Cryoablation for Benign Gastrointestinal Anastomotic Strictures

• Sponsor: University of Southern California (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04372784
• Collaborator: (none)
• Enrollment: 124
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Stricture; Duodenal Stricture; Jejunal Stricture; Anastomotic Stricture of Small Intestine	Device: Cryotherapy; Procedure: Esophagogastroduodenoscopy with Balloon Dilatation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of Cryotherapy on Benign Anastomotic Strictures Following Esophagectomy, Gastrectomy, and Bariatric Surgery
• Anticipated Study Start Date: Sep 1, 2020
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: EGD with Balloon Dilatation Esophagogastroduodenoscopy with balloon dilatation	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.
Experimental: EGD with Balloon Dilatation and Cryotherapy Esophagogastroduodenoscopy with balloon dilatation and cryotherapy	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.

Outcome Measures

Primary Outcome Measures

1. Number of Dilatations [One year]

   Total number of dilations within one year

Secondary Outcome Measures

1. Dilatation size [Immediately after the intervention/procedure/surgery/etc]

   Dilatation size (as a proportion to size at presentation)

2. Perforation rate [Immediately after the intervention/procedure/surgery/etc]

   Rates of hollow viscus perforation

3. Bleeding rate [Immediately after the intervention/procedure/surgery/etc]

   Rates of clinically significant bleeding

4. Fistula rate [One year]

   Rates of fistula formation

5. Reintervention [One year]

   Rates of unplanned reintervention (e.g., stenting)

6. Readmission [One year]

   Rates of readmission

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keck Hospital of USC	Los Angeles	California	United States	90033

Sponsors and Collaborators

• University of Southern California

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kulmeet Sandhu, Clinical Associate Professor of Surgery, University of Southern California
• ClinicalTrials.gov Identifier: NCT04372784
• Other Study ID Numbers: HS-19-00679
• First Posted: May 4, 2020
• Last Update Posted: May 5, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Esophageal Stenosis; Constriction, Pathologic

Study Results

No Results Posted as of May 5, 2020