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

Primary Purpose

Biliary Disease, Pancreatic Disease, Choledocholithiasis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Duodenoscope with single-use distal cover
Conventional duodenoscope
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Biliary Disease focused on measuring ERCP, Duodenoscope, Duodenoscope with single-use distal cover

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanford hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Duodenoscope with single-use distal cover

Conventional Duodenoscope

Arm Description

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

Patients will undergo ERCP using a conventional duodenoscope

Outcomes

Primary Outcome Measures

Number of participants with procedure-related adverse events
Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for superficial mucosal injury, perforation of the stomach or intestine, mucosal bleeding, pancreatitis, infection, death or any other symptom reported by the patient.

Secondary Outcome Measures

Duodenoscope maneuverability
Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for its maneuverability during the procedure using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver(1).
Duodenoscope mechanical characteristics profile
Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their mechanical characteristics (scope stiffness, air-water button functionality, elevator efficiency and hand strain). Each characteristic will be assessed using a published 5-point scoring system.
Duodenoscope imaging characteristics profile
Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their imaging characteristics (image quality and stability). Each characteristic will be assessed using a published 5-point scoring system.
Ability to perform interventions
Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their ability to perform endoscopic maneuvers like sphincterotomy, balloon sweep, use of basket/mechanical lithotriptor, stone clearance, stricture dilation using balloon/catheter, stent insertion, stent removal and use of single operator cholangioscopy/pancreatoscopy. Each patient's procedure will be assessed on a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.

Full Information

First Posted
June 17, 2022
Last Updated
October 24, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05429203
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 Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Disease, Pancreatic Disease, Choledocholithiasis, Biliary Obstruction, Biliary Tract Neoplasms, Pancreatic Neoplasms
Keywords
ERCP, Duodenoscope, Duodenoscope with single-use distal cover

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Duodenoscope with single-use distal cover
Arm Type
Active Comparator
Arm Description
Patients will undergo ERCP using a duodenoscope with a single-use distal cover
Arm Title
Conventional Duodenoscope
Arm Type
Active Comparator
Arm Description
Patients will undergo ERCP using a conventional duodenoscope
Intervention Type
Device
Intervention Name(s)
Duodenoscope with single-use distal cover
Intervention Description
Newer duodenoscope with a single-use distal cover
Intervention Type
Device
Intervention Name(s)
Conventional duodenoscope
Intervention Description
Conventional duodenoscope with standard methods of reprocessing
Primary Outcome Measure Information:
Title
Number of participants with procedure-related adverse events
Description
Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for superficial mucosal injury, perforation of the stomach or intestine, mucosal bleeding, pancreatitis, infection, death or any other symptom reported by the patient.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Duodenoscope maneuverability
Description
Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for its maneuverability during the procedure using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver(1).
Time Frame
Maneuverability will be assessed only during the procedure (approximately 10 minutes)
Title
Duodenoscope mechanical characteristics profile
Description
Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their mechanical characteristics (scope stiffness, air-water button functionality, elevator efficiency and hand strain). Each characteristic will be assessed using a published 5-point scoring system.
Time Frame
Mechanical and imaging characteristics will be assessed only during the procedure (approximately 15 minutes)
Title
Duodenoscope imaging characteristics profile
Description
Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their imaging characteristics (image quality and stability). Each characteristic will be assessed using a published 5-point scoring system.
Time Frame
Mechanical and imaging characteristics will be assessed only during the procedure (approximately 15 minutes)
Title
Ability to perform interventions
Description
Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their ability to perform endoscopic maneuvers like sphincterotomy, balloon sweep, use of basket/mechanical lithotriptor, stone clearance, stricture dilation using balloon/catheter, stent insertion, stent removal and use of single operator cholangioscopy/pancreatoscopy. Each patient's procedure will be assessed on a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.
Time Frame
30-60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subhas Banerjee, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
943305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pradeep Siddappa, MD
Phone
507-202-4577
Email
siddappa@stanford.edu
First Name & Middle Initial & Last Name & Degree
Siddappa K Siddappa, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33007136
Citation
Bang JY, Rosch T, Kim HM, Thakkar S, Robalino Gonzaga E, Tharian B, Inamdar S, Lee LS, Yachimski P, Jamidar P, Muniraj T, DiMaio C, Kumta N, Sethi A, Draganov P, Yang D, Seoud T, Perisetti A, Bondi G, Kirtane S, Hawes R, Wilcox CM, Kozarek R, Reddy DN, Varadarajulu S. Prospective evaluation of an assessment tool for technical performance of duodenoscopes. Dig Endosc. 2021 Jul;33(5):822-828. doi: 10.1111/den.13856. Epub 2020 Nov 17.
Results Reference
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Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope

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