Using a special dye to improve blood flow visualization during gastric bypass surgery
The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery
This study is testing a special dye to see if it helps doctors better visualize blood flow during gastric bypass surgery and reduce complications afterward.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06002906 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of near-infrared fluorescence imaging with indocyanine green (ICG) to visualize blood flow to the gastrojejunostomy during Roux-en-Y gastric bypass surgery. Patients will receive ICG before and after the surgical connection is made, allowing surgeons to assess blood flow and assign a perfusion score. The study aims to determine the long-term impact of this technique on complications such as marginal ulceration, leaks, and strictures. Data will be collected prospectively through standard follow-up visits for up to two years.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who are eligible for bariatric surgery and have been deemed appropriate for Roux-en-Y gastric bypass.
Not a fit: Patients with known allergies to indocyanine green or sodium iodide, or those not planning to undergo Roux-en-Y gastric bypass, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce complications associated with gastric bypass surgery, leading to better patient outcomes.
How similar studies have performed: Other studies using similar imaging techniques have shown promise, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- Toronto Western Hospital, University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Allan Okrainec — University Health Network, Toronto
- Study coordinator: Allan Okrainec, MDCM, MHPE
- Email: allan.okrainec@uhn.ca
- Phone: 4166035224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.