Cryoablation for Benign Gastrointestinal Anastomotic Strictures

Study Overview
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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.

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

Conditions
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Esophageal Stricture, Duodenal Stricture, Jejunal Stricture, Anastomotic Stricture of Small Intestine

Intervention / Treatment
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* Device: Cryotherapy
* Procedure: Esophagogastroduodenoscopy with Balloon Dilatation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EGD with Balloon Dilatation<br>Esophagogastroduodenoscopy with balloon dilatation | Procedure: Esophagogastroduodenoscopy with Balloon Dilatation<br>* 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.<br>|
| Experimental: EGD with Balloon Dilatation and Cryotherapy<br>Esophagogastroduodenoscopy with balloon dilatation and cryotherapy | Device: Cryotherapy<br>* 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<br>Procedure: Esophagogastroduodenoscopy with Balloon Dilatation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Dilatations | Total number of dilations within one year | One year | 

Secondary Outcome Measures

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