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Cryoablation for Benign Gastrointestinal Anastomotic Strictures

Primary Purpose

Esophageal Stricture, Duodenal Stricture, Jejunal Stricture

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cryotherapy
Esophagogastroduodenoscopy with Balloon Dilatation
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Stricture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keck Hospital of USC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

EGD with Balloon Dilatation

EGD with Balloon Dilatation and Cryotherapy

Arm Description

Esophagogastroduodenoscopy with balloon dilatation

Esophagogastroduodenoscopy with balloon dilatation and cryotherapy

Outcomes

Primary Outcome Measures

Number of Dilatations
Total number of dilations within one year

Secondary Outcome Measures

Dilatation size
Dilatation size (as a proportion to size at presentation)
Perforation rate
Rates of hollow viscus perforation
Bleeding rate
Rates of clinically significant bleeding
Fistula rate
Rates of fistula formation
Reintervention
Rates of unplanned reintervention (e.g., stenting)
Readmission
Rates of readmission

Full Information

First Posted
April 29, 2020
Last Updated
May 2, 2020
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT04372784
Brief Title
Cryoablation for Benign Gastrointestinal Anastomotic Strictures
Official Title
A Randomized Controlled Trial of Cryotherapy on Benign Anastomotic Strictures Following Esophagectomy, Gastrectomy, and Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Stricture, Duodenal Stricture, Jejunal Stricture, Anastomotic Stricture of Small Intestine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EGD with Balloon Dilatation
Arm Type
Active Comparator
Arm Description
Esophagogastroduodenoscopy with balloon dilatation
Arm Title
EGD with Balloon Dilatation and Cryotherapy
Arm Type
Experimental
Arm Description
Esophagogastroduodenoscopy with balloon dilatation and cryotherapy
Intervention Type
Device
Intervention Name(s)
Cryotherapy
Intervention Description
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
Procedure
Intervention Name(s)
Esophagogastroduodenoscopy with Balloon Dilatation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Dilatations
Description
Total number of dilations within one year
Time Frame
One year
Secondary Outcome Measure Information:
Title
Dilatation size
Description
Dilatation size (as a proportion to size at presentation)
Time Frame
Immediately after the intervention/procedure/surgery/etc
Title
Perforation rate
Description
Rates of hollow viscus perforation
Time Frame
Immediately after the intervention/procedure/surgery/etc
Title
Bleeding rate
Description
Rates of clinically significant bleeding
Time Frame
Immediately after the intervention/procedure/surgery/etc
Title
Fistula rate
Description
Rates of fistula formation
Time Frame
One year
Title
Reintervention
Description
Rates of unplanned reintervention (e.g., stenting)
Time Frame
One year
Title
Readmission
Description
Rates of readmission
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kulmeet Sandhu, MD
Phone
323 442 5831
Email
kulmeet.sandhu@med.usc.edu
Facility Information:
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kulmeet Sandhu, MD
Phone
323-442-5831
Email
kulmeet.sandhu@med.usc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Starting six months after study publication

Learn more about this trial

Cryoablation for Benign Gastrointestinal Anastomotic Strictures

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