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2020-03-01
2021-12
2021-12
100
NCT04709445
Charite University, Berlin, Germany
Charite University, Berlin, Germany
INTERVENTIONAL
Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses
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: * Esophageal resection * Subtotal or total gastrectomy with or without jejunal pouch reconstruction * Y-Roux-reconstruction * Right or left colonic interposition (iso- or antiperistaltic) Lower GI surgery: * Jejunal or ileal segmental resection * Ileal / Ileocoecal resection * Colectomy with restorative ileal pouch formation and ileal-pouch-anal anastomosis * Left or right-sided hemicolectomy * Sigmoid resection * Rectal resections (lower anterior resection (LAR), proctectomy with colo-anal anastomosis, abdominoperineal resection) * Stoma closure 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®.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-01-13 | N/A | 2021-01-13 |
2021-01-13 | N/A | 2021-01-14 |
2021-01-14 | N/A | 2021-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: ICG-NIRF Imaging and objective perfusion rate 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. | DIAGNOSTIC_TEST: ICG-NIRF Imaging plus ingress and egress analysis
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| anastomotic leak | number of patients suffering from an anastomotic leak within 30 days of operation | 30 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Operative and post-operative complications | Clavien-Dindo for complication-level classification | 30 days |
| Length of hospital stay | length in days | 100 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Benjamin Weixler, PD MD Phone Number: +49 30 450 622 798 Email: benjamin.weixler@charite.de |
Study Contact Backup Name: Leonard Lobbes, MD Phone Number: +49 30 450 622 789 Email: leonard.lobbes@charite.de |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
