Near-Infrared Fluorescence Imaging With Indocyanine Green to Evaluate Bowel Anastomoses in Gynecologic Oncology Surgery

NCT06871787 | Not Yet Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: 07.01.2025-3097444
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate if indocyanine green (ICG) fluorescence imaging helps reduce complications in bowel surgery performed during gynecologic cancer operations. 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.

Conditions

Gynecologic Cancers; Ovarian Cancer; Endometrial Cancers; Cervical Cancers; Vulvar Cancer; Anastomotic Leaks

Keywords

Indocyanine Green; Near-Infrared Imaging; Bowel Anastomosis; Gynecologic Oncology; Anastomotic Complications; Perfusion Assessment

Outcome Measures

Primary Outcomes (1)

• Rate of Anastomotic Complications within 30 Days After Surgery

  The primary outcome will be the incidence of anastomotic leaks, pelvic abscesses, and infections observed within 30 days following bowel anastomosis performed during gynecologic oncology surgery with indocyanine green-enhanced near-infrared fluorescence imaging.

  30 days after surgery

Secondary Outcomes (1)

• Number of Anastomoses Revised After Indocyanine Green Fluorescence Imaging

  Intraoperative (During Surgery)

Study Arms (1)

ICG Fluorescence Imaging Group

EXPERIMENTAL

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.

Drug: Indocyanine Green; Device: Near-Infrared Fluorescence Imaging System

Interventions

Indocyanine Green DRUG

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.

ICG Fluorescence Imaging Group

Near-Infrared Fluorescence Imaging System DEVICE

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.

ICG Fluorescence Imaging Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only female participants are eligible because the study specifically addresses surgical procedures performed for cancers affecting female reproductive organs.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18 years or older.
• 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.

You may not qualify if:

• Known allergy or hypersensitivity to indocyanine green (ICG).
• Pregnancy or breastfeeding at the time of surgery.
• Severe liver or kidney dysfunction limiting the use of ICG.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine, Department of Gynecologic Oncology

Istanbul, Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 31586247 BACKGROUND

• 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.

  PMID: 35024926 BACKGROUND

• 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.

  PMID: 33010938 BACKGROUND

• 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.

  PMID: 27474844 BACKGROUND

• 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.

  PMID: 18875031 BACKGROUND

• 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.

  PMID: 28610745 BACKGROUND

• 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.

  PMID: 30811909 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Uterine Cervical Neoplasms; Vulvar Neoplasms; Anastomotic Leak

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Uterine Cervical Diseases; Vulvar Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Samet Topuz, Prof.

  Istanbul University

  STUDY CHAIR

• Yagmur Minareci, Assist. Prof.

  Istanbul University

  STUDY DIRECTOR

Central Study Contacts

Atahan Toyran, Medical Doctor

CONTACT

+905057146233; atahan.toyran@istanbul.edu.tr

Yagmur Minareci, Assist. Prof.

CONTACT

+905053574361; dryagmurminareci@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

TU (1)