NCT06871787

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

Evaluation of Bowel Anastomoses During Gynecologic Oncology Surgery Using Near-Infrared Fluorescence Imaging With Indocyanine Green

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Istanbul University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In gynecologic cancer surgeries, complete removal of the tumor often requires bowel resection (removal of part of the intestine). After resection, surgeons perform bowel anastomosis to restore gastrointestinal continuity. However, anastomosis can sometimes fail, leading to complications such as leaks, pelvic abscesses, or infections. Such complications significantly affect patient health, recovery, and outcomes. 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

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

Interventions

Type	Name	Description
DRUG	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.
DEVICE	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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-09-01
• Completion: 2027-12-30
• First posted: 2025-03-12
• Last updated: 2025-03-14

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated drug study
• FDA-regulated device study