A Randomized Controlled Trial of Cryotherapy on Benign Anastomotic Strictures Following Esophagectomy, Gastrectomy, and Bariatric Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Number of Dilatations
研究概览
简要总结
Anastomotic stricture is a common complication following foregut surgery. The standard of care for these benign foregut anastomotic strictures is balloon dilatation. However, re-stenosis of strictures is also common, requiring frequent repetition of balloon dilatation. Cryotherapy is a novel therapy that may improve clinical outcomes following dilatation. The purpose of the present study is to conduct a randomized controlled trial to characterize the impact of cryotherapy on clinical outcomes and complications for benign anastomotic strictures following esophagectomy, gastrectomy, and bariatric surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Inclusion Critieria
- •History of esophagectomywith primary anastomosis
- •History of gastrectomy with primary anastomosis
- •History of bariatric surgery with primary anastomosis
- •History of anastomotic stricture
- •History of balloon dilatation at Keck Hospital of the University of Southern California
- •Exclusion Critieria
- •Patients treated at medical centers other than Keck Hospital of the University of Southern California
- •History of anastomotic stent placement
排除标准
- 未提供
研究组 & 干预措施
EGD with Balloon Dilatation
Esophagogastroduodenoscopy with balloon dilatation
干预措施: Esophagogastroduodenoscopy with Balloon Dilatation (Procedure)
EGD with Balloon Dilatation and Cryotherapy
Esophagogastroduodenoscopy with balloon dilatation and cryotherapy
干预措施: Cryotherapy (Device)
EGD with Balloon Dilatation and Cryotherapy
Esophagogastroduodenoscopy with balloon dilatation and cryotherapy
干预措施: Esophagogastroduodenoscopy with Balloon Dilatation (Procedure)
结局指标
主要结局
Number of Dilatations
时间窗: One year
Total number of dilations within one year
次要结局
- Fistula rate(One year)
- Readmission(One year)
- Reintervention(One year)
- Dilatation size(Immediately after the intervention/procedure/surgery/etc)
- Perforation rate(Immediately after the intervention/procedure/surgery/etc)
- Bleeding rate(Immediately after the intervention/procedure/surgery/etc)
研究者
Kulmeet Sandhu
Clinical Associate Professor of Surgery
University of Southern California