Clinical trial NCT06002906: The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery.
Official title: The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ulcer, Gastric
Obesity, Morbid
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Stryker Endoscopy
First posted: 2023-08-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: The applicability of ICG as an indicator of anastomotic blood flow during bariatric surgery.
timeFrame: 2 years
Secondary outcomes:
measure: The impact of ICG imaging on the rate of marginal ulcer and other complications (leaks, strictures).
timeFrame: 2 years
measure: To evaluate the safety of routine use of NIF imaging using ICG in bariatric patients.
timeFrame: 30 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital, University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Allan Okrainec
role: PRINCIPAL_INVESTIGATOR
References: