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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

319 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-25

Study Completion Date

2024-07-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Biliary Disease Pancreatic Disease Choledocholithiasis Biliary Obstruction Biliary Tract Neoplasms Pancreatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Duodenoscope with single-use distal cover

Patients will undergo ERCP using a duodenoscope with a single-use distal cover

Group Type ACTIVE_COMPARATOR

Duodenoscope with single-use distal cover

Intervention Type DEVICE

Newer duodenoscope with a single-use distal cover

Conventional Duodenoscope

Patients will undergo ERCP using a conventional duodenoscope

Group Type ACTIVE_COMPARATOR

Conventional duodenoscope

Intervention Type DEVICE

Conventional duodenoscope with standard methods of reprocessing

Interventions

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Duodenoscope with single-use distal cover

Newer duodenoscope with a single-use distal cover

Intervention Type DEVICE

Conventional duodenoscope

Conventional duodenoscope with standard methods of reprocessing

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No