Anastomotic Stricture of Small Intestine, Duodenal Stricture, Esophageal Stricture, Jejunal Stricture
Conditions
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.
Interventions
DEVICECryotherapy
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
PROCEDUREEsophagogastroduodenoscopy 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.
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Dilatations | One year | Total number of dilations within one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perforation rate | Immediately after the intervention/procedure/surgery/etc | Rates of hollow viscus perforation |
| Bleeding rate | Immediately after the intervention/procedure/surgery/etc | Rates of clinically significant bleeding |
| Dilatation size | Immediately after the intervention/procedure/surgery/etc | Dilatation size (as a proportion to size at presentation) |
| Reintervention | One year | Rates of unplanned reintervention (e.g., stenting) |
| Readmission | One year | Rates of readmission |
| Fistula rate | One year | Rates of fistula formation |
Countries
United States
Contacts
Primary ContactKulmeet Sandhu, MD
Outcome results
None listed