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Cryoablation for Benign Gastrointestinal Anastomotic Strictures

University of Southern California logo

University of Southern California

Status

Unknown

Conditions

Duodenal Stricture
Esophageal Stricture
Jejunal Stricture
Anastomotic Stricture of Small Intestine

Treatments

Procedure: Esophagogastroduodenoscopy with Balloon Dilatation
Device: Cryotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04372784
HS-19-00679

Details and patient eligibility

About

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.

Enrollment

124 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

124 participants in 2 patient groups

EGD with Balloon Dilatation
Active Comparator group
Description:
Esophagogastroduodenoscopy with balloon dilatation
Treatment:
Procedure: Esophagogastroduodenoscopy with Balloon Dilatation
EGD with Balloon Dilatation and Cryotherapy
Experimental group
Description:
Esophagogastroduodenoscopy with balloon dilatation and cryotherapy
Treatment:
Procedure: Esophagogastroduodenoscopy with Balloon Dilatation
Device: Cryotherapy

Trial contacts and locations

1

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Central trial contact

Kulmeet Sandhu, MD

Data sourced from clinicaltrials.gov

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