Clinical trial · Interventional
Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses
Objective Perfusion Rate Assessment of Gastrointestinal Anastomoses by Inflow and Outflow Analysis of Near-infrared Fluorescence Agents
NCT04709445CI-TRIAL-00049428unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abnormality of the Gastrointestinal Tract | — | UNRESOLVED | — |
| Bowel Ischemia | — | UNRESOLVED | — |
| Bowel Obstruction | — | UNRESOLVED | — |
| Cancer of the Gastrointestinal Tract | — | UNRESOLVED | — |
| Crohn Disease | — | UNRESOLVED | — |
| Diverticulitis | — | UNRESOLVED | — |
| Familial Adenomatous Polyposis | — | UNRESOLVED | — |
| Hepatobiliary Neoplasm | Hepatobiliary Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Neoplasms | Pancreatic Neoplasm |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG-NIRF Imaging plus ingress and egress analysis | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICG-NIRF Imaging and objective perfusion rate
- description
- 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.
- interventionNames
- Diagnostic Test: ICG-NIRF Imaging plus ingress and egress analysis
Primary outcomes (1)
- measure
- anastomotic leak
- timeFrame
- 30 days
- description
- number of patients suffering from an anastomotic leak within 30 days of operation
Secondary outcomes (2)
- measure
- Operative and post-operative complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 * capability of signing informed consent * diagnosis of malignancies of the upper gastrointestinal tract (GI), or malignancies of the lower GI, or malignancies of the hepatobiliary system, refractory ulcerative colitis, or Crohn's disease, or acute, inflammatory, degenerative functional or anatomical disorders * Surgery possible and medically indicated to the diagnosis (esophageal resection, or subtotal or total gastrectomy, or Y-Roux reconstruction, or right or left colonic interposition, or small bowel segment resection, or ileocecal resection, or colectomy, or proctectomy with restorative ileoanal pouch (one or two-stage), or left or right hemicolectomy, or sigmoid resection, or rectal resection (deep anterior resection (TAR)), or proctectomy with colo-anal anastomosis, or abdominoperineal resection, or stoma closure, or pancreaticoduodenectomy Exclusion Criteria: * liver disfunction (MELD score \> 10) * ICG (indocyanine green) specific exclusion criteria as per literature (intolerance to indocyanine green or sodium iodide, iodine allergy, hyperthyroidism, autonomous thyroid adenoma, focal or diffuse autonomies of the thyroid, previously badly tolerated injection of ICG) * pregnancy or breastfeeding
References
Publications (5)
- BACKGROUNDKassis 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. PMID 24075499
- BACKGROUNDMcDermott 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. PMID 25703524
- BACKGROUNDvan 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. PMID 30710314
- BACKGROUNDvan 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. PMID 29106320
- BACKGROUNDDegett 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. PMID 26968863