Spots Global Cancer Trial Database for Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope

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Trial Identification

Brief Title: Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope

Official Title: Comparison of Outcomes in Patients Undergoing Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) Using Duodenoscope With Single-use Distal Cover and Conventional Reusable Duodenoscope: A Randomized Controlled Trial

Study ID: NCT05429203

Conditions

Biliary Tract Neoplasms

Pancreatic Neoplasms

Interventions

Duodenoscope with single-use distal cover

Conventional duodenoscope

Study Description

Brief Summary: The purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using two types of currently available endoscopes. These are (1) duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope.

Detailed Description: The risks associated with the ERCP procedure will be explained to patients who meets the eligibility criteria. Consenting patients will be randomized to undergo Endoscopic retrograde cholangiopancreatography (ERCP) using either (1) a duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope. Assessments will be made during, and immediately after the procedure, then patients will be called after 1 week, 1 month, and 3 months after the procedure to get information about adverse events.