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NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures — SAMURAI  

Esophageal Stricture Clinical Trial

Official title:
Needle-knife inciSion therApy coMpared to Usual caRe of Recurrent Esophagogastric AnastomotIc Strictures: a Multicenter Randomized Controlled Trial

Clinical Trial Summary

Rationale: The study hypothesizes that NKI followed by endoscopic bougie dilation therapy will result in an increased dysphagia-free period, a reduction of endoscopic procedures and dysphagia-related quality of life, and lower costs, when compared with the standard endoscopic bougie dilation (EBD) in recurrent esophagogastric anastomotic strictures. Objective: To evaluate the efficacy and cost-effectiveness of needle-knife incision (NKI) followed by EBD compared to standard EBD in patients with recurrent esophagogastric anastomotic strictures. Study design: This multicenter study is an randomized controlled trial in which NKI followed by EBD will be compared with standard EBD. Study population: Patients with recurrent dysphagia (at least 1 and a maximum of 5 previous dilations) due to an anastomotic esophagogastric stricture that requires treatment with repeated endoscopic bougie dilations. Intervention : The intervention to be investigated is the addition of NKI therapy to EBD to 18 mm esophageal diameter. Main study parameters/endpoints: The primary outcome of this study will be EBD-free time during follow-up of 6 months. Secondary outcome parameters will be the number of endoscopic procedures for treatment of dysphagia, quality of life (QoL), cost-reduction and cost-effectiveness.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04406428
Study type Interventional
Source Radboud University Medical Center
Contact
Status Terminated
Phase N/A
Start date September 14, 2020
Completion date February 20, 2024
View Details
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