Cryoablation for Benign Gastrointestinal Anastomotic Strictures

Not Applicable

• Conditions: Jejunal Stricture; Anastomotic Stricture of Small Intestine; Esophageal Stricture; Duodenal Stricture
• Interventions: Procedure: Esophagogastroduodenoscopy with Balloon Dilatation; Device: Cryotherapy

• Registration Number: NCT04372784
• Lead Sponsor: University of Southern California

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-29
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-02
• Study First Posted: 2020-05-04
• Last Update Posted: 2020-05-05
• Study Start: 2020-09
• Primary Completion: 2022-08
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EGD with Balloon Dilatation	Esophagogastroduodenoscopy with Balloon Dilatation	Esophagogastroduodenoscopy with balloon dilatation
EGD with Balloon Dilatation and Cryotherapy	Esophagogastroduodenoscopy with Balloon Dilatation	Esophagogastroduodenoscopy with balloon dilatation and cryotherapy
EGD with Balloon Dilatation and Cryotherapy	Cryotherapy	Esophagogastroduodenoscopy with balloon dilatation and cryotherapy

Primary Outcome Measures

Name	Time	Method
Number of Dilatations	One year	Total number of dilations within one year

Secondary Outcome Measures

Name	Time	Method
Readmission	One year	Rates of readmission
Reintervention	One year	Rates of unplanned reintervention (e.g., stenting)
Dilatation size	Immediately after the intervention/procedure/surgery/etc	Dilatation size (as a proportion to size at presentation)
Perforation rate	Immediately after the intervention/procedure/surgery/etc	Rates of hollow viscus perforation
Fistula rate	One year	Rates of fistula formation
Bleeding rate	Immediately after the intervention/procedure/surgery/etc	Rates of clinically significant bleeding

Trial Locations

Locations (1)

Keck Hospital of USC; 🇺🇸 Los Angeles, California, United States