NCT07899125|Not Yet Recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
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Fluorescent Angiography in Reduction of Anastomotic Leak in Rectal Cancer Surgery
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Fluorescent Angiography in Reduction of Anastomotic Leak in Rectal Cancer Surgery
Sponsor study identifier
Secondary identifiers
REGISTRY · Clinical Trial Registry of India
interventional
610
1 country
1
Study Start
November 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
July 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to find out whether using a special green dye called indocyanine green (ICG) during minimally invasive rectal cancer surgery can help surgeons assess blood flow to the bowel and reduce leakage from the surgical connection between two ends of the bowel. The main questions this study aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2026
Actual (reported)October 27, 2026
Actual (reported)November 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Total Anastomotic Leakage Rate
Incidence of anastomotic leakage of any grade after surgery. Anastomotic leakage will include grade A, grade B, and grade C leaks. Grade A is a radiological leak without symptoms and without need for active treatment. Grade B is a symptomatic leak requiring non-surgical treatment such as antibiotics or drainage. Grade C is a symptomatic leak requiring reoperation.
Within 30 days after surgery
Clinically Significant Anastomotic Leakage Rate
Within 30 days after surgery
30-day postoperative morbidity
Within 30 days after surgery
Participants in this group will undergo planned colorectal cancer surgery with standard surgical assessment of bowel blood flow plus indocyanine green fluorescence angiography. Indocyanine green will be given intravenously during surgery, and near-infrared imaging will be used to assess blood flow at the planned bowel joining site. The surgeon may change the bowel transection level if fluorescence suggests poor blood flow.
Participants in this group will undergo planned colorectal cancer surgery with standard surgical assessment of bowel blood flow. The surgeon will assess bowel perfusion using usual clinical methods such as bowel color, bleeding from the cut edge, arterial pulsation, and overall tissue appearance. Indocyanine green fluorescence angiography will not be used.
Indocyanine green will be administered intravenously during surgery. Near-infrared fluorescence imaging will be used to assess bowel blood flow at the planned bowel joining site both for proximal large bowel end and distal rectal stump. The surgeon may change the bowel transection level if fluorescence suggests poor blood flow.
Bowel blood flow will be assessed using standard surgical judgment, including bowel color, bleeding from the cut edge, arterial pulsation, and overall tissue appearance.
Basavatarakam Indo American Cancer Hospital and Research Institute
Hyderabad, Telangana, 500034, India
Faber RA, Meijer RPJ, Droogh DHM, Jongbloed JJ, Bijlstra OD, Boersma F, Braak JPBM, Meershoek-Klein Kranenbarg E, Putter H, Holman FA, Mieog JSD, Neijenhuis PA, van Staveren E, Bloemen JG, Burger JWA, Aukema TS, Brouwers MAM, Marinelli AWKS, Westerterp M, Doornebosch PG, van der Weijde A, Bosscha K, Handgraaf HJM, Consten ECJ, Sikkenk DJ, Burggraaf J, Keereweer S, van der Vorst JR, Hutteman M, Peeters KCMJ, Vahrmeijer AL, Hilling DE. Indocyanine green near-infrared fluorescence bowel perfusion assessment to prevent anastomotic leakage in minimally invasive colorectal surgery (AVOID): a multicentre, randomised, controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024 Oct;9(10):924-934. doi: 10.1016/S2468-1253(24)00198-5. Epub 2024 Aug 13.
Jayne D, Croft J, Corrigan N, Quirke P, Cahill RA, Ainsworth G, Meads DM, Kirby A, Tolan D, Gordon K, Hompes R, Spinelli A, Foppa C, Wolthuis AM, D'Hoore A, Vignali A, Tilney HS, Moriarty C, Vargas-Palacios A, Young C, Kelly R, Stocken D; IntAct Collaborative Group. Intraoperative fluorescence angiography with indocyanine green to prevent anastomotic leak in rectal cancer surgery (IntAct): an unblinded randomised controlled trial. Lancet Gastroenterol Hepatol. 2025 Sep;10(9):806-817. doi: 10.1016/S2468-1253(25)00101-3. Epub 2025 Jul 18.
Syed Nusrath, MS,DNB(Gen Surg),DNB(Surg Onc)
Basavatarakam Indo American Hospital and Research Institute
Syed Nusrath, MS,DNB(Gen Surg),DNB(Surg Onc)
CONTACT
First Submitted
May 1, 2026
First Posted
October 27, 2026
Study Start
November 15, 2026
30-day postoperative mortality
Within 30 days after surgery
Rate of intraoperative modification of the proximal bowel transection line after ICG assessment.
During surgery, after ICG-FA assessment and before construction of the anastomosis
Rate of Intraoperative Modification of the Distal Rectal Stump Transection Line After ICG-FA Assessment
During surgery, after ICG-FA assessment and before construction of the anastomosis
Contact the study team to confirm eligibility.
Watanabe J, Takemasa I, Kotake M, Noura S, Kimura K, Suwa H, Tei M, Takano Y, Munakata K, Matoba S, Yamagishi S, Yasui M, Kato T, Ishibe A, Shiozawa M, Ishii Y, Yabuno T, Nitta T, Saito S, Saigusa Y, Watanabe M; EssentiAL Trial Group. Blood Perfusion Assessment by Indocyanine Green Fluorescence Imaging for Minimally Invasive Rectal Cancer Surgery (EssentiAL trial): A Randomized Clinical Trial. Ann Surg. 2023 Oct 1;278(4):e688-e694. doi: 10.1097/SLA.0000000000005907. Epub 2023 May 23.
Jafari MD, Pigazzi A, McLemore EC, Mutch MG, Haas E, Rasheid SH, Wait AD, Paquette IM, Bardakcioglu O, Safar B, Landmann RG, Varma MG, Maron DJ, Martz J, Bauer JJ, George VV, Fleshman JW Jr, Steele SR, Stamos MJ. Perfusion Assessment in Left-Sided/Low Anterior Resection (PILLAR III): A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT Near-Infrared Fluorescence Imaging in Low Anterior Resection. Dis Colon Rectum. 2021 Aug 1;64(8):995-1002. doi: 10.1097/DCR.0000000000002007.
Alekseev M, Rybakov E, Shelygin Y, Chernyshov S, Zarodnyuk I. A study investigating the perfusion of colorectal anastomoses using fluorescence angiography: results of the FLAG randomized trial. Colorectal Dis. 2020 Sep;22(9):1147-1153. doi: 10.1111/codi.15037. Epub 2020 Apr 6.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
July 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
Individual participant data will not be shared publicly because the study involves surgical patients and contains sensitive clinical information. Public sharing may risk participant privacy and confidentiality, even after de-identification. De-identified aggregate study results will be reported in publications and trial registry results, as required.
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