Cryoablation for Benign Gastrointestinal Anastomotic Strictures

NCT04372784 | Unknown FDA Device

• 1 other identifier: HS-19-00679
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Stricture; Duodenal Stricture; Jejunal Stricture; Anastomotic Stricture of Small Intestine

Outcome Measures

Primary Outcomes (1)

• Number of Dilatations

  Total number of dilations within one year

  One year

Secondary Outcomes (6)

• Dilatation size

  Immediately after the intervention/procedure/surgery/etc

• Perforation rate

  Immediately after the intervention/procedure/surgery/etc

• Bleeding rate

  Immediately after the intervention/procedure/surgery/etc

• Fistula rate

  One year

• Reintervention

  One year

Study Arms (2)

EGD with Balloon Dilatation

ACTIVE COMPARATOR

Esophagogastroduodenoscopy with balloon dilatation

Procedure: Esophagogastroduodenoscopy with Balloon Dilatation

EGD with Balloon Dilatation and Cryotherapy

EXPERIMENTAL

Esophagogastroduodenoscopy with balloon dilatation and cryotherapy

Device: Cryotherapy; Procedure: Esophagogastroduodenoscopy with Balloon Dilatation

Interventions

Cryotherapy 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

EGD with Balloon Dilatation and Cryotherapy

Esophagogastroduodenoscopy with Balloon Dilatation 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; EGD with Balloon Dilatation and Cryotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Esophageal Stenosis

Interventions

Cryotherapy; Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Kulmeet Sandhu, MD

CONTACT

323 442 5831; kulmeet.sandhu@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Surgery

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 4, 2020
• Study Start: September 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting six months after study publication

Locations

US (1)