- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05429203
Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope
April 15, 2024 updated by: Subhas Banerjee, Stanford University
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 943305
- Recruiting
- Stanford hospital
-
Contact:
- Pradeep Siddappa, MD
- Phone Number: 507-202-4577
- Email: siddappa@stanford.edu
-
Sub-Investigator:
- Siddappa K Siddappa, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Duodenoscope with single-use distal cover
Patients will undergo ERCP using a duodenoscope with a single-use distal cover
|
Newer duodenoscope with a single-use distal cover
|
Active Comparator: Conventional Duodenoscope
Patients will undergo ERCP using a conventional duodenoscope
|
Conventional duodenoscope with standard methods of reprocessing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with procedure-related adverse events
Time Frame: 3 months
|
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duodenoscope maneuverability
Time Frame: Maneuverability will be assessed only during the procedure (approximately 10 minutes)
|
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).
|
Maneuverability will be assessed only during the procedure (approximately 10 minutes)
|
Duodenoscope mechanical characteristics profile
Time Frame: Mechanical and imaging characteristics will be assessed only during the procedure (approximately 15 minutes)
|
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.
|
Mechanical and imaging characteristics will be assessed only during the procedure (approximately 15 minutes)
|
Duodenoscope imaging characteristics profile
Time Frame: Mechanical and imaging characteristics will be assessed only during the procedure (approximately 15 minutes)
|
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.
|
Mechanical and imaging characteristics will be assessed only during the procedure (approximately 15 minutes)
|
Ability to perform interventions
Time Frame: 30-60 minutes
|
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.
|
30-60 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Subhas Banerjee, MD, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 25, 2022
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
June 17, 2022
First Submitted That Met QC Criteria
June 17, 2022
First Posted (Actual)
June 23, 2022
Study Record Updates
Last Update Posted (Actual)
April 17, 2024
Last Update Submitted That Met QC Criteria
April 15, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Biliary Tract Diseases
- Bile Duct Diseases
- Common Bile Duct Diseases
- Cholelithiasis
- Neoplasms
- Pancreatic Neoplasms
- Pancreatic Diseases
- Biliary Tract Neoplasms
- Choledocholithiasis
- Gallbladder Diseases
Other Study ID Numbers
- 65189
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreatic Neoplasms
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CelgeneWithdrawnPancreatic Ductal Adenocarcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Cancer Metastatic | Pancreatic Cancer Stage IV | Metastatic Pancreatic Carcinoma | Metastatic Pancreatic Adenocarcinoma | Pancreatic Carcinoma | Metastatic Pancreatic Cancer | Pancreatic Cancer Non-resectable | Metastatic Pancreatic Ductal Adenocarcinoma | Pancreatic Carcinoma... and other conditionsUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedPancreatic Adenocarcinoma | Resectable Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer | Poorly Differentiated Malignant Neoplasm | Undifferentiated Pancreatic CarcinomaUnited States
-
The First Affiliated Hospital with Nanjing Medical...RecruitingLocally Advanced Pancreatic Adenocarcinoma | Metastatic Pancreatic Cancer | Pancreatic NeoplasmChina
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer
-
National Cancer Institute (NCI)CompletedStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
University of UtahNovartis PharmaceuticalsRecruitingMetastatic Pancreatic Carcinoma | Unresectable Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic CancerUnited States
-
University of OxfordNational Institute for Health Research, United Kingdom; ImunonWithdrawnPancreatic Cancer Metastatic | Pancreatic Ductal Adenocarcinoma | Pancreatic Cancer Stage IV | Pancreatic Cancer Non-resectableUnited Kingdom
-
Mayo ClinicNational Cancer Institute (NCI)CompletedAdvanced Pancreatic Carcinoma | Metastatic Pancreatic Carcinoma | Stage II Pancreatic Cancer AJCC v8 | Stage III Pancreatic Cancer AJCC v8 | Stage IV Pancreatic Cancer AJCC v8 | Unresectable Pancreatic Carcinoma | Pancreatic Neoplasm | Locally Advanced Pancreatic CarcinomaUnited States
-
Maria LiljeforsKarolinska University Hospital; Karolinska Institutet; CelgeneCompletedPancreatic Ductal Adenocarcinoma | Pancreatic Carcinoma MetastaticSweden
Clinical Trials on Duodenoscope with single-use distal cover
-
Nottingham University Hospitals NHS TrustCompleted
-
Nottingham University Hospitals NHS TrustNot yet recruiting
-
Boston Scientific CorporationCompletedEndoscopic Retrograde CholangiopancreatographyUnited States, Netherlands
-
Boston Scientific CorporationCompletedEndoscopic Retrograde CholangiopancreatographyUnited States
-
Boston Scientific CorporationCompletedEndoscopic Retrograde CholangiopancreatographyUnited States, France, Hong Kong, Singapore, Australia, Canada, Germany, India, Italy, Netherlands, South Africa
-
Boston Scientific CorporationWithdrawnCholangiopancreatography
-
Peking University Third HospitalBeijing Friendship HospitalCompletedSingle-use Precision Filter Infusion SetChina
-
Rigshospitalet, DenmarkCompletedDifficult Airway | Tracheal IntubationDenmark
-
Medacta USACompletedOsteo Arthritis Knee | Total Knee ArthroplastyUnited States
-
University Hospital, Clermont-FerrandGroupe LépineCompletedTotal Hip Replacement | CoxarthrosisFrance