Cryoablation for Benign Gastrointestinal Anastomotic Strictures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Esophageal Stricture Duodenal Stricture Jejunal Stricture Anastomotic Stricture of Small Intestine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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EGD with Balloon Dilatation

Esophagogastroduodenoscopy with balloon dilatation

Group Type ACTIVE_COMPARATOR

Esophagogastroduodenoscopy with Balloon Dilatation

Intervention Type PROCEDURE

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.

EGD with Balloon Dilatation and Cryotherapy

Esophagogastroduodenoscopy with balloon dilatation and cryotherapy

Group Type EXPERIMENTAL

Cryotherapy

Intervention Type DEVICE

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

Esophagogastroduodenoscopy with Balloon Dilatation

Intervention Type PROCEDURE

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.

Interventions

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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

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No