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| ID | Type | Description | Link |
|---|---|---|---|
| OCR40380 | Other Identifier | UF OnCore | |
| PRO00043219 | Other Identifier | UFIRST |
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| Name | Class |
|---|---|
| Society of University Surgeons | OTHER |
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Near-infrared fluorescence (NIRF) imaging after an intravenous injection of indocyanine green (ICG) allows for the intraoperative identification of liver anatomy. The investigators have new data that a much lower dose improves this visualization. Confirmation of this hypothesis would mean that ICG can be administered on the same day of surgery in order to augment real-time intraoperative visualization, thereby providing a safe, feasible, and cost-effective strategy for the surgical treatment of liver disease.
The investigators have a series of surgical cases in which the investigators have been able to achieve excellent intraoperative biliary visualization with a greatly decreased (50-200 fold lower) dose of ICG than the previously published dose. Furthermore, this decreased dose was visible in about 15-20 minutes from the time of injection with low liver background fluorescence, a significant improvement that would make its utilization in the operating room more practical. The investigators hypothesize that a lower dose will: 1) allow adequate visualization of the extrahepatic biliary tree, including the cystic, common hepatic, and common bile ducts. Confirmation of hypotheses would mean that a lower dose of ICG can be administered on the same day of surgery in order to augment real-time intraoperative localization of the extrahepatic biliary tree, thereby providing a safe, feasible, and cost-effective strategy for the surgical treatment of liver disease.
The investigators intend to test our hypothesis with the following specific aims:
Aim 1: To compare the efficacy and utility of a low dose ICG (0.05 mg) protocol with a previously published dose (2.5 mg) in imaging the extrahepatic biliary tract.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | Prior to surgery these patients will be given a ICG dose of 0.05 mg IV. |
|
| Standard Dose | Placebo Comparator | Prior to surgery these patients will be given the ICG standard dose of 2.5 mg IV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green | Drug | Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety). |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio | Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the liver | intraoperative, average of 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White Light | A qualitative assessment will be made based on the quality of the intraoperative visualization of the extrahepatic biliary tree on a scale of 1 to 5 (1 = no improvement/identification not confirmed; 2 = marginally improved; 3 = sufficiently improved; 4 = well improved; 5 = greatly improved/exceeds expectations). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Zarrinpar, MD, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Health Shands | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36728303 | Derived | Ladd AD, Zarate Rodriguez J, Lewis D, Warren C, Duarte S, Loftus TJ, Nassour I, Soma D, Hughes SJ, Hammill CW, Zarrinpar A. Low vs Standard-Dose Indocyanine Green in the Identification of Biliary Anatomy Using Near-Infrared Fluorescence Imaging: A Multicenter Randomized Controlled Trial. J Am Coll Surg. 2023 Apr 1;236(4):711-717. doi: 10.1097/XCS.0000000000000553. Epub 2023 Jan 10. |
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We are not sharing individual participant data with other researchers
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No enrolled patients were excluded from the study prior to group assignment.
Patients undergoing a planned laparoscopic cholecystectomy were approached between September 2021 to August 2022 in pre-surgical clinic and consented for a randomized ICG dose administration.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose | Prior to surgery these patients will be given a ICG dose of 0.05 mg IV. Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety). PINPOINT Endoscopic Fluorescence: The PINPOINT Endoscopic Fluorescence Imaging System (Stryker Corporation, Kalamazoo, Michigan) will be used. This device enables the surgeon to simultaneously see real-time, high-definition visible-range and NIR fluorescence videos and to superimpose them. It is currently approved by the FDA for intraoperative near-infrared fluorescence imaging. |
| FG001 | Standard Dose | Prior to surgery these patients will be given a ICG dose of 2.5 mg IV. Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
5 enrolled and randomized patients were excluded from analysis because their videos were either too dark or unusable due to technical issues with the scope, camera, or device tower.
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose | Prior to surgery these patients will be given a ICG dose of 0.05 mg IV. Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio | Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the liver | Posted | Median | Inter-Quartile Range | ratio | intraoperative, average of 2 hours |
|
Adverse event data were collected through study completion, an average of 24 hours.
ICG is a very safe drug with minimal risk for adverse advents. Participants were given a very low dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose | Study participants who received low dose ICG. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ali Zarrinpar | University of Florida | (352) 265-0606 | ali.zarrinpar@surgery.ufl.edu |
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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 9, 2021 | Jun 12, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2022 | Jun 12, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 15, 2022 | Jun 12, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D006528 | Carcinoma, Hepatocellular |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D000230 | Adenocarcinoma |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Adult patients scheduled to undergo a laparoscopic hepatic or biliary operation will be randomized to two groups 1) low dose (0.05 mg) or 2) standard dose (2.5 mg) of ICG preoperatively on the day of surgery. Patients with a history of adverse reactions or known allergy to ICG, iodine, or iodine dyes will be excluded.
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To mask the investigator randomization will be done with envelopes for this study and the dose given to the patient prior to surgery with the investigator not being aware of the amount given.
|
|
| PINPOINT Endoscopic Fluorescence | Device | The PINPOINT Endoscopic Fluorescence Imaging System (Stryker Corporation, Kalamazoo, Michigan) will be used. This device enables the surgeon to simultaneously see real-time, high-definition visible-range and NIR fluorescence videos and to superimpose them. It is currently approved by the FDA for intraoperative near-infrared fluorescence imaging. |
|
|
| intraoperative, average of 2 hours |
| Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity Ratio | Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the background fat | intraoperative, average of 2 hours |
| Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts) | A qualitative assessment will be made based on the quality of the intraoperative visualization of the extrahepatic biliary tree on a scale of 1 to 5 (1 = no improvement/identification not confirmed; 2 = marginally improved; 3 = sufficiently improved; 4 = well improved; 5 = greatly improved/exceeds expectations). | intraoperative, average of 2 hours |
| BG001 | Standard Dose | Prior to surgery these patients will be given a ICG dose of 2.5 mg IV. Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Prior to surgery these patients will be given a ICG dose of 2.5 mg IV.
Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).
|
|
| Secondary | Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White Light | A qualitative assessment will be made based on the quality of the intraoperative visualization of the extrahepatic biliary tree on a scale of 1 to 5 (1 = no improvement/identification not confirmed; 2 = marginally improved; 3 = sufficiently improved; 4 = well improved; 5 = greatly improved/exceeds expectations). | Posted | Mean | Standard Deviation | score on a scale | intraoperative, average of 2 hours |
|
|
|
| Secondary | Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity Ratio | Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the background fat | Posted | Median | Inter-Quartile Range | ratio | intraoperative, average of 2 hours |
|
|
|
| Secondary | Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts) | A qualitative assessment will be made based on the quality of the intraoperative visualization of the extrahepatic biliary tree on a scale of 1 to 5 (1 = no improvement/identification not confirmed; 2 = marginally improved; 3 = sufficiently improved; 4 = well improved; 5 = greatly improved/exceeds expectations). | Posted | Mean | Standard Deviation | score on a scale | intraoperative, average of 2 hours |
|
|
|
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Standard Dose | Study participants who received standard dose ICG. | 0 | 26 | 0 | 26 | 0 | 26 |
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| D002277 |
| Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D008107 | Liver Diseases |
| Common Bile Duct |
|
| Aberrant Duct |
|