The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery
Overview
- Phase
- Phase 4
- Intervention
- Indocyanine green
- Conditions
- Ulcer, Gastric
- Sponsor
- University Health Network, Toronto
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- The applicability of ICG as an indicator of anastomotic blood flow during bariatric surgery.
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
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.
Investigators
Allan Okrainec
MD, MHPE, FACS, FRCSC (Principal Investigator)
University Health Network, Toronto
Eligibility Criteria
Inclusion Criteria
- •Capacity to provide informed consent.
- •Over the Age of
- •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
Arms & Interventions
Interventional group (with drug)
The interventional group will receive indocyanine green during bariatric surgery inside the operating room before and after making the gastrojejunostomy.
Intervention: Indocyanine green
Interventional group (with drug)
The interventional group will receive indocyanine green during bariatric surgery inside the operating room before and after making the gastrojejunostomy.
Intervention: Stryker 1688 AIM system
Outcomes
Primary Outcomes
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
- To evaluate the safety of routine use of NIF imaging using ICG in bariatric patients.(30 days)
- The impact of ICG imaging on the rate of marginal ulcer and other complications (leaks, strictures).(2 years)