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

Stanford University

Status

Completed

Conditions

Biliary Disease

Biliary Tract Neoplasms

Biliary Obstruction

Pancreatic Disease

Choledocholithiasis

Pancreatic Neoplasms

Treatments

Device: Duodenoscope with single-use distal cover

Device: Conventional duodenoscope

Study type

Interventional

Funder types

Other

Identifiers

NCT05429203

65189

Details and patient eligibility

About

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.

Full 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.

Enrollment

319 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients undergoing ERCP for biliary and pancreatic conditions
Age > 18 years old

Exclusion criteria

Vulnerable patient groups including pregnant women
Patients who are unable to consent
Patients with known cholangitis
Patients with known Carbapenem-Resistant Enterobacteriaceae (CRE) or any other multi-drug resistant organisms (MDRO) infection
Surgically altered anatomy except for Billroth I