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In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at two to three time points during procedures of upper GI, lower GI and hepatobiliary surgery with anastomosis formation in open or laparoscopic surgery. Postoperatively, a detailed software-based assessment of each recording is performed to determine the objective ICG-NIRF perfusion rate before and after anastomosis formation, which is then correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak.
Near-infrared-fluorescence by indocyanine green (ICG-NIRF) utilises the fluorescent property of intravenously injected indocyanine green (ICG) as an intravascular indicator of tissue and bowel perfusion.
The investigators hypothesise that ICG-NIRF is a suitable, reliable and precise method of visualisation of the blood supply and bowel perfusion in the area of gastrointestinal and hepatobiliary anastomosis formation.
In this prospective, non-randomized cohort study, the respective upper GI, lower GI or hepatobiliary procedure with anastomosis is performed according to standard of care and indication for the corresponding disease including non-malignant, malignant and inflammatory conditions. The following procedures are included in the study, in open or laparoscopic surgery, according to the surgeon's choice:
Upper GI surgery:
Lower GI surgery:
Hepatobiliary surgery:
- Pancreaticoduodenectomy
Written informed consent for participation and ICG-administration is obtained one day before surgery.
Intraoperatively, Indocyanine Green (ICG, VerDye, Diagnostic Green GmbH, Aschheim Germany, 25 mg vials) is dissolved in 5 mL sterile water to yield a 5 mg/mL concentration. It will then be administered intravenously at three consecutive time points as a bolus of 2 ml per time point at the most. The overall dose of ICG will amount to no more than 30mg of ICG per patient.
Real-time intraoperative visualization is performed with the SpectrumTM Fluorescence Imaging Platform (Quest Innovations, Middenmeer, The Netherlands) directly after each ICG injection assessing bowel perfusion at two different time points per anastomosis respectively: before and after anastomosis formation.
Postoperative NIRF-perfusion rate assessment Using the Quest Research SoftwareTM, the recordings before and after anastomosis formation will be analysed for their perfusion rate. This analysis will provide objective, quantitative data on the perfusion for a certain time frame which is determined by the length of the video recording. This data will be collected for statistical analysis and correlation with anastomotic leak as well as postoperative outcome.
Clinical data and follow-up Clinical data will be collected from all patients regarding anastomotic leak, bowel ischemia and necrosis as well as 30 day postoperative morbidity, mortality and length and cost of hospital stay.
Further data analysis will be performed using Microsoft Excel® and IBM SPSS®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG-NIRF Imaging and objective perfusion rate | Experimental | Intraoperatively, ICG-NIRF imaging is used to visualize the blood supply and the rate of tissue perfusion in the area of the anastomotic site. Postoperatively, an additional ingress and egress analysis at specific regions of interest is performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICG-NIRF Imaging plus ingress and egress analysis | Diagnostic Test | intraoperative NIRF Imaging using the fluorescence agent ICG (indocyanine-green) before and after anastomosis formation, postoperative analysis of ingress and egress for specific regions of interest |
| Measure | Description | Time Frame |
|---|---|---|
| anastomotic leak | number of patients suffering from an anastomotic leak within 30 days of operation | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Operative and post-operative complications | Clavien-Dindo for complication-level classification | 30 days |
| Length of hospital stay | length in days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Weixler, PD MD | Contact | +49 30 450 622 798 | benjamin.weixler@charite.de | |
| Leonard Lobbes, MD | Contact | +49 30 450 622 789 | leonard.lobbes@charite.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Campus Benjamin Franklin | Recruiting | Berlin | 12203 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24075499 | Background | Kassis ES, Kosinski AS, Ross P Jr, Koppes KE, Donahue JM, Daniel VC. Predictors of anastomotic leak after esophagectomy: an analysis of the society of thoracic surgeons general thoracic database. Ann Thorac Surg. 2013 Dec;96(6):1919-26. doi: 10.1016/j.athoracsur.2013.07.119. Epub 2013 Sep 24. | |
| 25703524 | Background |
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This is a non-randomised prospective cohort study design.
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| 100 days |
| McDermott FD, Heeney A, Kelly ME, Steele RJ, Carlson GL, Winter DC. Systematic review of preoperative, intraoperative and postoperative risk factors for colorectal anastomotic leaks. Br J Surg. 2015 Apr;102(5):462-79. doi: 10.1002/bjs.9697. Epub 2015 Feb 19. |
| 30710314 | Background | van den Bos J, Jongen ACHM, Melenhorst J, Breukink SO, Lenaerts K, Schols RM, Bouvy ND, Stassen LPS. Near-infrared fluorescence image-guidance in anastomotic colorectal cancer surgery and its relation to serum markers of anastomotic leakage: a clinical pilot study. Surg Endosc. 2019 Nov;33(11):3766-3774. doi: 10.1007/s00464-019-06673-6. Epub 2019 Feb 1. |
| 29106320 | Background | van den Bos J, Al-Taher M, Schols RM, van Kuijk S, Bouvy ND, Stassen LPS. Near-Infrared Fluorescence Imaging for Real-Time Intraoperative Guidance in Anastomotic Colorectal Surgery: A Systematic Review of Literature. J Laparoendosc Adv Surg Tech A. 2018 Feb;28(2):157-167. doi: 10.1089/lap.2017.0231. Epub 2017 Nov 6. |
| 26968863 | Background | Degett TH, Andersen HS, Gogenur I. Indocyanine green fluorescence angiography for intraoperative assessment of gastrointestinal anastomotic perfusion: a systematic review of clinical trials. Langenbecks Arch Surg. 2016 Sep;401(6):767-75. doi: 10.1007/s00423-016-1400-9. Epub 2016 Mar 11. |
| ID | Term |
|---|---|
| D007415 | Intestinal Obstruction |
| D004238 | Diverticulitis |
| D005770 | Gastrointestinal Neoplasms |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D011125 | Adenomatous Polyposis Coli |
| D010190 | Pancreatic Neoplasms |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D015212 | Inflammatory Bowel Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D018256 | Adenomatous Polyps |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D044483 | Intestinal Polyposis |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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