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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000904-36 | EudraCT Number |
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| Name | Class |
|---|---|
| Instituto de Investigación Biomédica de Salamanca | OTHER |
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Laparoscopic cholecystectomy is one of the most performed surgical procedures worldwide. One of its most serious complications is injury to the main bile duct, with an incidence of less than 1%. There are different surgical strategies that try to reduce this complication, with indocyanine green fluorescence cholangiography being one of the most recent to appear. This technique is becoming a great tool during laparoscopic cholecystectomy. Despite the great rise of the procedure, today there is a great disparity in the administration protocols of indocyanine green during the procedure.
Goals. The main objective of the study is to analyze whether there are differences between different types of doses and administration intervals of indocyanine green to obtain quality fluorescent cholangiography during laparoscopic cholecystectomy. In addition, the factors that influence the results of the technique will be sought.
Symptomatic cholelithiasis is a pathology of great relevance in the world population, with prevalence rates of up to 20%. The standard treatment for cholelithiasis is laparoscopic cholecystectomy (LC). One of the most serious complications of LC is injury to the main bile duct (LVB). Although this complication has incidences of less than 1% (0.3-0.7% in the different series), the consequences it causes are highly relevant. LVB is related to a significant increase in patient morbidity and mortality, a significant deterioration in quality of life, a very significant increase in healthcare costs and not insignificant medical-legal consequences. Indocyanine green fluorescence cholangiography (CF-VI) is a novel technique that allows precise and real-time anatomical visualization of the extrahepatic biliary anatomy, facilitating surgery and reducing the risk of complications. Currently, there are large differences in LV administration protocols during CF in LC. The precise dose and the ideal moment of administration are key to achieving adequate visualization of the critical vascular and biliary structures and to reduce the fluorescence emitted by the hepatic parenchyma, which could hinder correct anatomical visualization. In relation to the dose, there are many protocols for IV administration, by means of a single dose or a dose adjusted for the patient's body weight. Some authors advocate the administration of IV 24 hours before the procedure, in order to avoid hepatic fluorescence. However, in the context of major outpatient surgery, outpatient surgery or short-stay surgery, we believe that this practice is not currently logistically feasible. Other groups administer the IV with a variable range of time interval. The recent preliminary results of the European Registry of Fluorescent Image Guided Surgery show the great disparity of preoperative LV administration protocols. Therefore, it is necessary to protocolize the administration of the drug based on the results of randomized clinical trials.. The precise dose and the ideal moment of administration are key to achieving adequate visualization of the critical vascular and biliary structures and to reduce the fluorescence emitted by the hepatic parenchyma, which could hinder correct anatomical visualization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed dose 3 hours | Experimental | Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery. |
|
| Fixed dose 30 min | Experimental | Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery). |
|
| Weight-adjusted dose 3 hour | Experimental | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery. |
|
| Weight-adjusted dose 30 min | Experimental | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VERDYE powder for solution for injection 25 mg | Drug | Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver. |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Identification of biliary structures prior to dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection | During surgical procedure, before beginning the dissection of the hepatocystic triangle. |
| Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Identification of biliary structures after dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection | During surgical procedure, after dissection of the hepatocystic triangle. |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Degree of identification of biliary structures prior to dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime López Sánchez, MD | University of Salamanca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Germans Trias i Pujol. | Badalona | Barcelona | 08916 | Spain | ||
| Complejo Asistencial Universitario de Salamanca |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27307785 | Background | Ansaloni L, Pisano M, Coccolini F, Peitzmann AB, Fingerhut A, Catena F, Agresta F, Allegri A, Bailey I, Balogh ZJ, Bendinelli C, Biffl W, Bonavina L, Borzellino G, Brunetti F, Burlew CC, Camapanelli G, Campanile FC, Ceresoli M, Chiara O, Civil I, Coimbra R, De Moya M, Di Saverio S, Fraga GP, Gupta S, Kashuk J, Kelly MD, Koka V, Jeekel H, Latifi R, Leppaniemi A, Maier RV, Marzi I, Moore F, Piazzalunga D, Sakakushev B, Sartelli M, Scalea T, Stahel PF, Taviloglu K, Tugnoli G, Uraneus S, Velmahos GC, Wani I, Weber DG, Viale P, Sugrue M, Ivatury R, Kluger Y, Gurusamy KS, Moore EE. 2016 WSES guidelines on acute calculous cholecystitis. World J Emerg Surg. 2016 Jun 14;11:25. doi: 10.1186/s13017-016-0082-5. eCollection 2016. | |
| 27942871 |
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All IPD that underlie results in a publication
From the date of publication of the results.
Through access to the journal where the results are published.
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Screening details:
Patients scheduled for laparoscopic cholecystectomy who meet all inclusion criteria and none of the exclusion criteria
The annual rate of LC in the two hospitals in the study is over 300 surgeries per year. In order to recruit 200 in both centres, a review waiting list will be conducted. Patients who meet the inclusion criteria will be given the necessary information and, after signing the informed consent form, will be included in the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fixed Dose 3 Hours | Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery. |
| FG001 | Fixed Dose 30 Min | Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 16, 2022 | Mar 21, 2025 |
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Subjects included in this CT will be treated with VI [Verdye (Diagnostic Green GMBH, Aschheim-Dornach, Germany)]. Single dose and weight-adjusted dose and different administration intervals will be analyzed. Low-intervention clinical trial.
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|
|
| During surgical procedure, before beginning the dissection of the hepatocystic triangle. |
| Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Degree of identification of biliary structures after dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the disection of the hepatocystic triangle has begun. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name. | During surgical procedure, after the disection of the hepatocystic triangle has begun. |
| Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery | Extent to which fluorescence cholangiography was perceived as useful for surgery. Participants were assigned toeach category according to the intraoperative identification of distinct anatomical structures observed in each case,once the surgery has begun. The following scale will be used: 0=not useful, 1=moderately useful, 2=very useful. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name. | During surgical procedure |
| Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Extent to which liver fundus fluorescence (contrast between liver and ducts) was perceived as disturbing. Participants were assigned to each category according to the intraoperative identification of distinct anatomical structures observed in each case, once the surgery has begun. The following scale will be used: 0=no disturbance, 1=slightly disturbed, 2=disturbed visualization, but cystic-bile duct junction was clearly visible before dissection, 3=disturbed visualization and cystic-bile duct junction was only visible after dissection. dissection and 4= very disturbed: it was impossible to correctly visualize the biliary structures. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name. | During surgical procedure |
| Salamanca |
| 37007 |
| Spain |
| Background |
| Tazuma S, Unno M, Igarashi Y, Inui K, Uchiyama K, Kai M, Tsuyuguchi T, Maguchi H, Mori T, Yamaguchi K, Ryozawa S, Nimura Y, Fujita N, Kubota K, Shoda J, Tabata M, Mine T, Sugano K, Watanabe M, Shimosegawa T. Evidence-based clinical practice guidelines for cholelithiasis 2016. J Gastroenterol. 2017 Mar;52(3):276-300. doi: 10.1007/s00535-016-1289-7. Epub 2016 Dec 10. |
| 34629815 | Background | Pesce A, Piccolo G, Lecchi F, Fabbri N, Diana M, Feo CV. Fluorescent cholangiography: An up-to-date overview twelve years after the first clinical application. World J Gastroenterol. 2021 Sep 28;27(36):5989-6003. doi: 10.3748/wjg.v27.i36.5989. |
| 16230550 | Background | Nuzzo G, Giuliante F, Giovannini I, Ardito F, D'Acapito F, Vellone M, Murazio M, Capelli G. Bile duct injury during laparoscopic cholecystectomy: results of an Italian national survey on 56 591 cholecystectomies. Arch Surg. 2005 Oct;140(10):986-92. doi: 10.1001/archsurg.140.10.986. |
| 8000648 | Background | Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995 Jan;180(1):101-25. No abstract available. |
| 30842813 | Background | Gupta V, Jain G. Safe laparoscopic cholecystectomy: Adoption of universal culture of safety in cholecystectomy. World J Gastrointest Surg. 2019 Feb 27;11(2):62-84. doi: 10.4240/wjgs.v11.i2.62. |
| 33201104 | Background | Mascagni P, Vardazaryan A, Alapatt D, Urade T, Emre T, Fiorillo C, Pessaux P, Mutter D, Marescaux J, Costamagna G, Dallemagne B, Padoy N. Artificial Intelligence for Surgical Safety: Automatic Assessment of the Critical View of Safety in Laparoscopic Cholecystectomy Using Deep Learning. Ann Surg. 2022 May 1;275(5):955-961. doi: 10.1097/SLA.0000000000004351. Epub 2020 Nov 16. |
| 12672731 | Background | Flum DR, Dellinger EP, Cheadle A, Chan L, Koepsell T. Intraoperative cholangiography and risk of common bile duct injury during cholecystectomy. JAMA. 2003 Apr 2;289(13):1639-44. doi: 10.1001/jama.289.13.1639. |
| 27844236 | Background | Vlek SL, van Dam DA, Rubinstein SM, de Lange-de Klerk ESM, Schoonmade LJ, Tuynman JB, Meijerink WJHJ, Ankersmit M. Biliary tract visualization using near-infrared imaging with indocyanine green during laparoscopic cholecystectomy: results of a systematic review. Surg Endosc. 2017 Jul;31(7):2731-2742. doi: 10.1007/s00464-016-5318-7. Epub 2016 Nov 14. |
| 20623766 | Background | Ishizawa T, Bandai Y, Ijichi M, Kaneko J, Hasegawa K, Kokudo N. Fluorescent cholangiography illuminating the biliary tree during laparoscopic cholecystectomy. Br J Surg. 2010 Sep;97(9):1369-77. doi: 10.1002/bjs.7125. |
| 26359355 | Background | Reinhart MB, Huntington CR, Blair LJ, Heniford BT, Augenstein VA. Indocyanine Green: Historical Context, Current Applications, and Future Considerations. Surg Innov. 2016 Apr;23(2):166-75. doi: 10.1177/1553350615604053. Epub 2015 Sep 10. |
| 33398590 | Background | Lim SH, Tan HTA, Shelat VG. Comparison of indocyanine green dye fluorescent cholangiography with intra-operative cholangiography in laparoscopic cholecystectomy: a meta-analysis. Surg Endosc. 2021 Apr;35(4):1511-1520. doi: 10.1007/s00464-020-08164-5. Epub 2021 Jan 4. |
| 30614881 | Background | Dip F, LoMenzo E, Sarotto L, Phillips E, Todeschini H, Nahmod M, Alle L, Schneider S, Kaja L, Boni L, Ferraina P, Carus T, Kokudo N, Ishizawa T, Walsh M, Simpfendorfer C, Mayank R, White K, Rosenthal RJ. Randomized Trial of Near-infrared Incisionless Fluorescent Cholangiography. Ann Surg. 2019 Dec;270(6):992-999. doi: 10.1097/SLA.0000000000003178. |
| 29777357 | Background | van den Bos J, Wieringa FP, Bouvy ND, Stassen LPS. Optimizing the image of fluorescence cholangiography using ICG: a systematic review and ex vivo experiments. Surg Endosc. 2018 Dec;32(12):4820-4832. doi: 10.1007/s00464-018-6233-x. Epub 2018 May 18. |
| 24232054 | Background | Verbeek FP, Schaafsma BE, Tummers QR, van der Vorst JR, van der Made WJ, Baeten CI, Bonsing BA, Frangioni JV, van de Velde CJ, Vahrmeijer AL, Swijnenburg RJ. Optimization of near-infrared fluorescence cholangiography for open and laparoscopic surgery. Surg Endosc. 2014 Apr;28(4):1076-82. doi: 10.1007/s00464-013-3305-9. |
| 28660320 | Background | Widjaja SP, Fischer H, Brunner AR, Honigmann P, Metzger J. Acceptance of Ambulatory Laparoscopic Cholecystectomy in Central Switzerland. World J Surg. 2017 Nov;41(11):2731-2734. doi: 10.1007/s00268-017-4098-0. |
| 31591654 | Background | Agnus V, Pesce A, Boni L, Van Den Bos J, Morales-Conde S, Paganini AM, Quaresima S, Balla A, La Greca G, Plaudis H, Moretto G, Castagnola M, Santi C, Casali L, Tartamella L, Saadi A, Picchetto A, Arezzo A, Marescaux J, Diana M. Fluorescence-based cholangiography: preliminary results from the IHU-IRCAD-EAES EURO-FIGS registry. Surg Endosc. 2020 Sep;34(9):3888-3896. doi: 10.1007/s00464-019-07157-3. Epub 2019 Oct 7. |
| 15273542 | Background | Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. |
| 29032636 | Background | Yokoe M, Hata J, Takada T, Strasberg SM, Asbun HJ, Wakabayashi G, Kozaka K, Endo I, Deziel DJ, Miura F, Okamoto K, Hwang TL, Huang WS, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Noguchi Y, Shikata S, Ukai T, Higuchi R, Gabata T, Mori Y, Iwashita Y, Hibi T, Jagannath P, Jonas E, Liau KH, Dervenis C, Gouma DJ, Cherqui D, Belli G, Garden OJ, Gimenez ME, de Santibanes E, Suzuki K, Umezawa A, Supe AN, Pitt HA, Singh H, Chan ACW, Lau WY, Teoh AYB, Honda G, Sugioka A, Asai K, Gomi H, Itoi T, Kiriyama S, Yoshida M, Mayumi T, Matsumura N, Tokumura H, Kitano S, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):41-54. doi: 10.1002/jhbp.515. Epub 2018 Jan 9. |
| 36868593 | Derived | Lopez-Sanchez J, Garrosa-Munoz S, Pardo Aranda F, Gene Skrabec C, Lopez Perez R, Rodriguez-Fortunez P, Sanchez Santos JM, Munoz-Bellvis L; DOTIG Collaborative Group. Dose and administration time of indocyanine green in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy (DOTIG): study protocol for a randomised clinical trial. BMJ Open. 2023 Mar 3;13(3):e067794. doi: 10.1136/bmjopen-2022-067794. |
| FG002 | Weight-adjusted Dose 3 Hour | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery. |
| FG003 | Weight-adjusted Dose 30 Min | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery). |
| COMPLETED |
|
| NOT COMPLETED |
|
Of the 200 overall number of baseline participants, 196 completed the study; therefore, only the results and data obtained from these 196 subjects were used for the corresponding statistical analyses
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fixed Dose 3 Hours | Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery. |
| BG001 | Fixed Dose 30 Min | Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery). |
| BG002 | Weight-adjusted Dose 3 Hour | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery. |
| BG003 | Weight-adjusted Dose 30 Min | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||
| Sex: Female, Male | Of the 200 overall number of baseline participants, 196 completed the study; therefore, only the results and data obtained from these 196 subjects were used for the corresponding statistical analyses | Count of Participants | Participants | No |
| |||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Body mass index (BMI) | Mean | Standard Deviation | Kilogram per square meter |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Identification of biliary structures prior to dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection | Posted | Count of Participants | Participants | During surgical procedure, before beginning the dissection of the hepatocystic triangle. |
|
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| Primary | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Identification of biliary structures after dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection | Posted | Count of Participants | Participants | During surgical procedure, after dissection of the hepatocystic triangle. |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Degree of identification of biliary structures prior to dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name. | Posted | Count of Participants | Participants | During surgical procedure, before beginning the dissection of the hepatocystic triangle. |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Degree of identification of biliary structures after dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the disection of the hepatocystic triangle has begun. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name. | Posted | Count of Participants | Participants | During surgical procedure, after the disection of the hepatocystic triangle has begun. |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery | Extent to which fluorescence cholangiography was perceived as useful for surgery. Participants were assigned toeach category according to the intraoperative identification of distinct anatomical structures observed in each case,once the surgery has begun. The following scale will be used: 0=not useful, 1=moderately useful, 2=very useful. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name. | Posted | Count of Participants | Participants | During surgical procedure |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Extent to which liver fundus fluorescence (contrast between liver and ducts) was perceived as disturbing. Participants were assigned to each category according to the intraoperative identification of distinct anatomical structures observed in each case, once the surgery has begun. The following scale will be used: 0=no disturbance, 1=slightly disturbed, 2=disturbed visualization, but cystic-bile duct junction was clearly visible before dissection, 3=disturbed visualization and cystic-bile duct junction was only visible after dissection. dissection and 4= very disturbed: it was impossible to correctly visualize the biliary structures. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name. | Posted | Count of Participants | Participants | During surgical procedure |
|
The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total Number of Patients | All patients who completed the study, regardless of the group to which they were randomized. Adverse events were not analyzed separately by study arm but rather aggregated across all participants. Consequently, in the following sections, all references to adverse events pertain to this combined analysis. This approach was selected because the occurrence of adverse events is primarily related to the surgical intervention required for each patient's underlying pathology, rather than to the treatment arm to which the patient was randomized. Therefore, stratifying adverse events by study arm would not yield specific information regarding the dose or timing of administration of the investigational medicinal product. | 0 | 196 | 13 | 196 | 66 | 196 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adenocarcinoma | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute pancreatitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cholecystitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cholangitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Intraabdominal fluid collection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ecchymosis | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Fever | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Anxiety disorders | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dehiscense | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
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| Sinus arrhythmia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Disorientation | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute cholecystitis necrotic | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gallbladder rupture | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Omphalitis | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Sacral pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abcess | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Abcess intestinal | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Luis Muñoz BellvÃs | Instituto de Investigación Biomédica de Salamanca (IBSAL) | 0034 923 29 11 00 | luismb@usal.es |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 16, 2022 | Apr 15, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 7, 2022 | Mar 21, 2025 | ICF_002.pdf |
| ID | Term |
|---|---|
| D012996 | Solutions |
| D007267 | Injections |
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
|
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| Category 2 |
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| Category 3 |
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| Category 4 |
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| Category 5 |
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| Category 6 |
|
Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery). VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver. |
| OG002 | Weight-adjusted Dose 3 Hour | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery. VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver. |
| OG003 | Weight-adjusted Dose 30 Min | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery). VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver. |
|
|
| OG002 | Weight-adjusted Dose 3 Hour | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery. VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver. |
| OG003 | Weight-adjusted Dose 30 Min | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery). VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver. |
|
|
| OG002 | Weight-adjusted Dose 3 Hour | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery. VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver. |
| OG003 | Weight-adjusted Dose 30 Min | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery). VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver. |
|
|
| OG002 | Weight-adjusted Dose 3 Hour | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery. VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver. |
| OG003 | Weight-adjusted Dose 30 Min | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery). VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver. |
|
|
| OG002 | Weight-adjusted Dose 3 Hour | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery. VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver. |
| OG003 | Weight-adjusted Dose 30 Min | Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery). VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver. |
|
|