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NCT Number: NCT06002906

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T2S8, Canada

About this study

The purpose of this study is to examine intraoperative usefulness of near-infrared light fluorescence imaging with a contrast agent called indocyanine green to improve visualization of blood flow to a surgical connection between the small intestine and stomach (gastrojejunostomy) in patients undergoing gastric bypass surgery. ICG will be given prior to and after making the gastrojejunostomy to examine blood flow and then a subjective perfusion score will be given by the surgeon and assistant during the surgery.

Patients will be recruited before the laparoscopic Roux-en-Y gastric bypass surgery and the study data will be collected prospectively through standard bariatric follow up visits up to 2 years. A mid-term analysis of the procedure and patient outcomes will be performed for quality assurance purposes when half the study patients have undergone intraoperative ICG use. The ICG will be not given if a patient is allergic to sodium iodide or has a history of allergy to iodides because of the risk of a severe allergic reaction.

Participants will be assigned an identifying number to protect confidentiality. Descriptive univariate and multivariate statistical analysis will be performed on all patients satisfying the study's inclusion criteria.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: SPY AGENT GREEN

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.

Primary outcomes

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

    Time frame: 2 years

    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.

Secondary outcomes

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

    Time frame: 2 years

    The patients in the Toronto Western Hospital as per the standard care of bariatric program will be followed for up to 2 years following surgery to identify any complications including marginal ulcerations. Data is collected prospectively at the study site. The investigator will also use the data from the 5-point scale scoring system reference above to determine the correlation between the scores and the occurrence of marginal ulcers and any other complications (leaks, strictures).

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

    Time frame: 30 days

    Based on the literature, the investigator does not anticipate intra-operative or injection-related adverse effects. Nevertheless, the investigator will use the existing database that collects postoperative outcomes for 30 days to identify adverse events, if any.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Stryker Endoscopy

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2023
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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