The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery.

NCT06002906 | Active Not Recruiting Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: 20-5008
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This is an interventional pilot study aimed to evaluate the use of NIF imaging as an intraoperative aid to assess the anastomotic blood flow to the gastric pouch and gastrojejunostomy during Roux-en-Y gastric bypass surgery and to determine its long-term impact on the rate of marginal ulceration, leaks and stricture.

Conditions

Ulcer, Gastric; Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

• The applicability of ICG as an indicator of anastomotic blood flow during bariatric surgery.

  ICG imaging will be performed intraoperatively using an existing imaging system (1688 Advanced Imaging Modalities (AIM) System (Stryker)), and the images will be assessed by the operating surgeons and as well as by an independent surgeon (part of the study team, independent from the surgery) postoperatively using a subjective assessment of intraoperative Fluorescence Intensity (FI), a 5-point scale to check blood flow of the stomach and small intestine at the new connection. The scale range is 1 to 5 where a score of 1 signifies no fluorescence signal and poor blood supply whereas a score of 5 signifies maximum fluorescence signal and blood supply. Images will also be analyzed postoperatively to obtain an objective score based on fluorescence intensity. The applicability of ICG imaging in the context of RYGB will be assessed based on the inter-observer agreement.

  2 years

Secondary Outcomes (2)

• The impact of ICG imaging on the rate of marginal ulcer and other complications (leaks, strictures).

  2 years

• To evaluate the safety of routine use of NIF imaging using ICG in bariatric patients.

  30 days

Study Arms (1)

Interventional group (with drug)

EXPERIMENTAL

The interventional group will receive indocyanine green during bariatric surgery inside the operating room before and after making the gastrojejunostomy.

Drug: Indocyanine green; Device: Stryker 1688 AIM system

Interventions

Indocyanine green DRUG

Indocyanine green (ICG) is a safe, sterile, water-soluble molecule that binds to plasma proteins and can be injected intravenously. ICG will be injected intravenously based on the patient's weight prior to and after making the GJ anastomosis and a 10 mL bolus of normal saline will be immediately followed the injection of indocyanine green by an anesthesiologist. A subjective score of 1-5 for perfusion will be assigned by operating surgeons. The RYGB will then be completed by the operating surgeon in their routine fashion.

Also known as: SPY AGENT GREEN

Interventional group (with drug)

Stryker 1688 AIM system DEVICE

The Stryker 1688 AIM system used during laparoscopic surgery which is sensitive in the visible and infrared spectrum. ICG (SPY AGENT™ GREEN) is used with the SPY mode in the Stryker 1688 AIM fluorescence imaging system to perform intraoperative fluorescence angiography.

Interventional group (with drug)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capacity to provide informed consent.
• Over the Age of 18.
• Eligible for bariatric surgery in Ontario and deemed an appropriate candidate for RYGB surgery by the bariatric program.
• Commit to follow-up within the bariatric program, including behavioral and dietary modifications designed to aid in sustained weight-loss.
• Treatment of marginal ulcer with the revisional surgery.

You may not qualify if:

• Not willing to participate in study
• Contraindication to, or not planned to undergo RYGB
• Known allergy to indocyanine green or Sodium Iodide
• Is participant pregnant or planning to get pregnant in next two years
• Ongoing substance abuse or active smoking
• Bleeding diathesis or Coagulopathy
• Unwilling to take PPI medication Post operatively

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Stryker Endoscopy: collaborator

Study Sites (1)

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T2S8, Canada

Location

MeSH Terms

Conditions

Stomach Ulcer; Obesity, Morbid

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Allan Okrainec

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MHPE, FACS, FRCSC (Principal Investigator)

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 21, 2023
• Study Start: January 25, 2023
• Primary Completion (Estimated): July 3, 2027
• Study Completion (Estimated): July 3, 2027
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)