NCT04372784

Cryoablation for Benign Gastrointestinal Anastomotic Strictures

A Randomized Controlled Trial of Cryotherapy on Benign Anastomotic Strictures Following Esophagectomy, Gastrectomy, and Bariatric Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Esophageal Stricture
• Duodenal Stricture
• Jejunal Stricture
• Anastomotic Stricture of Small Intestine

Interventions

Type	Name	Description
DEVICE	Cryotherapy	Cryotherapy entails introducing a 9 French catheter via the endoscope's accessory port. The catheter is advanced until it is visualized on the endoscopy monitor. Under 4 psi pressure, liquid nitrogen is sprayed from the catheter for twenty seconds over each four-centimeter segment of stricture
PROCEDURE	Esophagogastroduodenoscopy with Balloon Dilatation	This procedure entails deploying a balloon via the accessory port of the esophagogastroduodenoscope under direct visualization and serially inflating the balloon. Balloon dilatation disrupts not only the muscular rings surrounding strictures but also the granulation tissue composing the strictures.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-08-01
• Completion: 2022-12-01
• First posted: 2020-05-04
• Last updated: 2020-05-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study