Cryoablation for Benign Gastrointestinal Anastomotic Strictures

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

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Stricture; Duodenal Stricture; Jejunal Stricture; Anastomotic Stricture of Small Intestine
• Intervention / Treatment: Procedure: Esophagogastroduodenoscopy with Balloon Dilatation; Device: Cryotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kulmeet Sandhu, MD; Phone Number: 323 442 5831; Email: kulmeet.sandhu@med.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Keck Hospital of USC
      • Contact: Kulmeet Sandhu, MD; Phone Number: 323-442-5831; Email: kulmeet.sandhu@med.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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	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.; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Southern California

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 2, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Esophageal Diseases; Constriction, Pathologic; Esophageal Stenosis
• Other Study ID Numbers: HS-19-00679

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Starting six months after study publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• 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