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NCT06793280
Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Colorectal Surgery
NA trial testing intraoperative ICG angiography in Anastomotic Leak in 562 participants. Currently enrolling.
6 May 2025
Quick facts
| Lead sponsor | University of Roma La Sapienza |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 562 |
| Start date | 6 May 2023 |
| Primary completion | 6 May 2025 |
| Estimated completion | 6 September 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- intraoperative ICG angiography
- No intraoperative ICG angiography
Conditions studied
- Anastomotic Leak — all drugs for Anastomotic Leak →
Sponsor
University of Roma La Sapienza
Who can join
Adults 18 to 85, any sex, with Anastomotic Leak. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Despite advancements in technology and improved surgical techniques, the occurrence of anastomotic leakage (AL) after colorectal surgery remains between 4% and 30%. AL is a feared complication associated with significant morbidity and mortality in colorectal surgery, with its causes being multifaceted. Inadequate blood supply to the intestines is believed to be a major contributor to its development. Various methods have been proposed to objectively assess intestinal perfusion beyond the subjective evaluation done by surgeons during surgery. However, these methods face challenges such as poor reproducibility and high costs, limiting their routine use. In recent years, indocyanine green (ICG) angiography has emerged as a tool for assessing organ perfusion in various medical scenarios. However, only one randomized clinical trial has been conducted regarding its use in evaluating colorectal surgery outcomes, which found that while ICG angiography sometimes led to additional bowel resection, it didn't significantly reduce the rate of anastomotic leaks compared to conventional methods. This could be due to the trial's small sample size, potentially reducing its statistical power. This study aims to investigate whether ICG angiography can lower the rate of anastomotic leaks during laparoscopic colorectal cancer surgery, while also examining its impact on resection margins, perioperative morbidity, and mortality rates. A total of 561 subjects undergoing laparoscopic colorectal surgery for malignancy, will be randomized in 2 arms: A Study Group undergoing ICG angiography (i.e. colonic perfusion is intraoperatively assessed by ICG angiography and level of resection is selected based on the fluorescence) and a Control Group (i.e. resection is performed based on subjective judgment).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Impact of fluorescence angiography on anastomotic leak and complication rate in colorectal surgery: A systematic review and meta-analysis of randomized controlled trials.
Balaphas A, Sleiman MJ, Meurette G, Liot E, et al · · 2025 · cited 3× · PMID 41031406 · DOI 10.1111/codi.70236
Verify or expand the search:
- PubMed search for NCT06793280
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other University of Roma La Sapienza trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06793280 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Roma La Sapienza
- Last refreshed: 19 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06793280.
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