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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
124
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
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.
Keck Hospital of USC
Los Angeles, California, United States
Number of Dilatations
Total number of dilations within one year
Time frame: One year
Dilatation size
Dilatation size (as a proportion to size at presentation)
Time frame: Immediately after the intervention/procedure/surgery/etc
Perforation rate
Rates of hollow viscus perforation
Time frame: Immediately after the intervention/procedure/surgery/etc
Bleeding rate
Rates of clinically significant bleeding
Time frame: Immediately after the intervention/procedure/surgery/etc
Fistula rate
Rates of fistula formation
Time frame: One year
Reintervention
Rates of unplanned reintervention (e.g., stenting)
Time frame: One year
Readmission
Rates of readmission
Time frame: One year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.