The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- mucosal leak
研究概览
简要总结
The aim this prospective observational study is to evaluate the role of Indocyanine Green Fluorescence (ICG) in patients with achalasia underwent to Heller-Dor laparoscopic. The main gol are:
- If with use of ICG iatrogenic mucosal leaks can be identified and, if necessary, improve the myotomy.
- Assess the need for postoperative radiographic control using esophagogastric radiography with gastrografin.
- Compare clinical characteristics, perioperative outcomes, and 12-month postoperative follow-up between the two populations.
详细描述
Achalasia is a rare disease of motility characterized by dysfunction of low esophageal sphincter (LES). This disease is divided according to Chicago classification. Laparoscopic Heller - Dor is gold standard of types I and II Achalasia. The use of intraoperative indocyanine green (ICG) fluorescence in recent years is becoming an interesting and innovative tool for surgical procedures. Its use is widely described in surgery The aim of our study is to value the role of ICG for this surgery. The investigators prospectively enrolled achalasic patients undergoing laparoscopic Heller -Dor .
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •patients with achalasia of type I and II
- •patients undergoing laparoscopic Heller-Dor
- •patients older than 18 years
排除标准
- •Patients <18 years of age;
- •Uncooperative patients and/or patients unable to provide informed consent
- •Patients previously treated with other endoscopic/surgical procedures (botulinum toxin injections, dilation, POEM, myotomy)
- •Patients with achalasia type III
- •Patients with megaesophagus
- •Allergy to dyes or contrast agents included in the protocol (e.g., indocyanine green, barium, gastrografin)
结局指标
主要结局
mucosal leak
时间窗: Intraoperative
Directly visualize intraoperatively the presence or absence of an esophageal mucosal lesion through the color change due to indocyanine green fluorescence.
Completeness of myotomy
时间窗: intraoperative
Intraoperatively visualize the presence or absence of residual muscle fibers after myotomy through the use of indocyanine green fluorescence.
次要结局
- Length of stay(From the first to the fourth post-operative day)
- Perioperative complications(Perioperative/Periprocedural)
研究者
Giuseppe Palomba
Principal Investigator
Federico II University