The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The applicability of ICG as an indicator of anastomotic blood flow during bariatric surgery.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Interventional group (with drug)
The interventional group will receive indocyanine green during bariatric surgery inside the operating room before and after making the gastrojejunostomy.
干预措施: Indocyanine green (Drug)
Interventional group (with drug)
The interventional group will receive indocyanine green during bariatric surgery inside the operating room before and after making the gastrojejunostomy.
干预措施: Stryker 1688 AIM system (Device)
结局指标
主要结局
The applicability of ICG as an indicator of anastomotic blood flow during bariatric surgery.
时间窗: 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.
次要结局
- 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)
研究者
Allan Okrainec
MD, MHPE, FACS, FRCSC (Principal Investigator)
University Health Network, Toronto