Near-Infrared Fluorescence Imaging With Indocyanine Green to Evaluate Bowel Anastomoses in Gynecologic Oncology Surgery
NCT ID: NCT06871787
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2025-09-01
2027-12-30
Brief Summary
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The main question it aims to answer is: Does using ICG fluorescence imaging during bowel anastomosis reduce the rate of complications such as leaks, infections, and abscesses within 30 days after surgery? Participants are women aged 18 and older undergoing surgery for gynecologic cancers (such as ovarian, uterine, cervical, or vulvar cancer). During surgery, investigators will inject ICG intravenously, then use a special near-infrared camera to see how well blood flows at the anastomosis site. The investigators will then decide if the reconnection is good enough or needs adjustment.
Researchers will record any complications within the first 30 days after surgery to understand if this imaging method helps reduce surgical risks.
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Detailed Description
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Indocyanine green (ICG) is a dye approved by health authorities for clinical use. When injected into the bloodstream, it glows brightly under near-infrared (NIR) light, allowing investigators to visually assess blood flow in tissues during surgery. Good blood flow is critical for proper healing of the bowel reconnection.
This study aims to evaluate the effectiveness of using ICG-enhanced NIR fluorescence imaging specifically during gynecologic oncology surgeries involving bowel resections. After surgeons complete the anastomosis, ICG will be administered intravenously. Investigators will then examine the blood flow at the anastomosis site using a special near-infrared camera. If the blood flow appears insufficient, investigators may choose to revise the bowel connection during the same operation.
The study will include approximately 50 women undergoing surgery for gynecologic cancers such as ovarian, uterine, cervical, or vulvar cancer. The primary goal is to determine whether the use of this imaging technique reduces complications, especially within the first 30 days after surgery.
The results of this research could lead to safer surgical procedures, improved patient outcomes, and potentially influence clinical practice guidelines in gynecologic oncology.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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ICG Fluorescence Imaging Group
Women undergoing gynecologic oncology surgery with bowel resection and anastomosis. Anastomotic perfusion will be evaluated intraoperatively using indocyanine green (ICG) enhanced near-infrared fluorescence imaging.
Indocyanine Green
Indocyanine green (ICG), administered intravenously at a dose of 2.5 mg/ml, will be used during surgery to evaluate bowel anastomosis perfusion through near-infrared fluorescence imaging.
Near-Infrared Fluorescence Imaging System
A near-infrared fluorescence imaging device will be used intraoperatively to visualize indocyanine green (ICG) fluorescence, assessing the perfusion of bowel anastomoses during gynecologic oncology surgery.
Interventions
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Indocyanine Green
Indocyanine green (ICG), administered intravenously at a dose of 2.5 mg/ml, will be used during surgery to evaluate bowel anastomosis perfusion through near-infrared fluorescence imaging.
Near-Infrared Fluorescence Imaging System
A near-infrared fluorescence imaging device will be used intraoperatively to visualize indocyanine green (ICG) fluorescence, assessing the perfusion of bowel anastomoses during gynecologic oncology surgery.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of gynecologic cancer (ovarian, endometrial, cervical, vulvar) requiring surgical treatment.
* Planned bowel resection and anastomosis during gynecologic oncology surgery.
* Ability and willingness to provide informed consent.
Exclusion Criteria
* Pregnancy or breastfeeding at the time of surgery.
* Severe liver or kidney dysfunction limiting the use of ICG.
18 Years
FEMALE
No
Sponsors
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Istanbul University
OTHER
Responsible Party
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Atahan Toyran
Principal Investigator
Principal Investigators
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Samet Topuz, Prof.
Role: STUDY_CHAIR
Istanbul University
Yagmur Minareci, Assist. Prof.
Role: STUDY_DIRECTOR
Istanbul University
Locations
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Istanbul University, Istanbul Faculty of Medicine, Department of Gynecologic Oncology
Istanbul, Istanbul, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Morales-Conde S, Alarcon I, Yang T, Licardie E, Camacho V, Aguilar Del Castillo F, Balla A. Fluorescence angiography with indocyanine green (ICG) to evaluate anastomosis in colorectal surgery: where does it have more value? Surg Endosc. 2020 Sep;34(9):3897-3907. doi: 10.1007/s00464-019-07159-1. Epub 2019 Oct 4.
Emile SH, Khan SM, Wexner SD. Impact of change in the surgical plan based on indocyanine green fluorescence angiography on the rates of colorectal anastomotic leak: a systematic review and meta-analysis. Surg Endosc. 2022 Apr;36(4):2245-2257. doi: 10.1007/s00464-021-08973-2. Epub 2022 Jan 13.
Chan DKH, Lee SKF, Ang JJ. Indocyanine green fluorescence angiography decreases the risk of colorectal anastomotic leakage: Systematic review and meta-analysis. Surgery. 2020 Dec;168(6):1128-1137. doi: 10.1016/j.surg.2020.08.024. Epub 2020 Oct 1.
Parthasarathy M, Greensmith M, Bowers D, Groot-Wassink T. Risk factors for anastomotic leakage after colorectal resection: a retrospective analysis of 17 518 patients. Colorectal Dis. 2017 Mar;19(3):288-298. doi: 10.1111/codi.13476.
BRUNSCHWIG A. Complete excision of pelvic viscera for advanced carcinoma; a one-stage abdominoperineal operation with end colostomy and bilateral ureteral implantation into the colon above the colostomy. Cancer. 1948 Jul;1(2):177-83. doi: 10.1002/1097-0142(194807)1:23.0.co;2-a. No abstract available.
Grimm C, Harter P, Alesina PF, Prader S, Schneider S, Ataseven B, Meier B, Brunkhorst V, Hinrichs J, Kurzeder C, Heitz F, Kahl A, Traut A, Groeben HT, Walz M, du Bois A. The impact of type and number of bowel resections on anastomotic leakage risk in advanced ovarian cancer surgery. Gynecol Oncol. 2017 Sep;146(3):498-503. doi: 10.1016/j.ygyno.2017.06.007. Epub 2017 Jun 10.
Harter P, Sehouli J, Lorusso D, Reuss A, Vergote I, Marth C, Kim JW, Raspagliesi F, Lampe B, Aletti G, Meier W, Cibula D, Mustea A, Mahner S, Runnebaum IB, Schmalfeldt B, Burges A, Kimmig R, Scambia G, Greggi S, Hilpert F, Hasenburg A, Hillemanns P, Giorda G, von Leffern I, Schade-Brittinger C, Wagner U, du Bois A. A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms. N Engl J Med. 2019 Feb 28;380(9):822-832. doi: 10.1056/NEJMoa1808424.
Other Identifiers
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07.01.2025-3097444
Identifier Type: -
Identifier Source: org_study_id
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