Clinical trial

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

Active, not recruiting · Phase 4 · 1 countries · Registry ID NCT06002906

Active, not recruitingPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionUlcer, Gastric, Obesity, Morbid

Full registry criteria

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

Treatments and study arms

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.

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

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Toronto Western Hospital, University Health Network🇨🇦 Toronto, Ontario, Canada

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