Motorized Spiral Enteroscopy-assisted ERCP in Surgically Altered Anatomy
June 18, 2021 updated by: Evangelisches Krankenhaus Düsseldorf
Patients with surgically altered anatomy receiving Motorized Spiral Eneroscopy (MSE)-assisted ERCP at a single endoscopic reference center for various indications are planned to be retrospectively enrolled
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
All consecutive patients with altered upper gastrointestinal anatomy after Billroth-II- or Roux-en-Y reconstructive surgery and indication for ERCP with biliary and/or pancreatic indication, who underwent routine Enteroscopy-assisted ERCP using MSE, at the study center during the study period, will be enrolled in the analysis.
Primary endpoint of the study will be efficacy and safety of MSE-assisted ERCP.
Retrospective epidemiologic Study (not interventional) was approved by local IRB and ethical committee of the North-Rhine Chamber of Physicians (Düsseldorf, Germany), Reference Number: 177/2021.
Study Type
Observational
Enrollment (Anticipated)
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Torsten Beyna, MD PhD
- Phone Number: 00492119191605
- Email: torsten.beyna@evk-duesseldorf.de
Study Contact Backup
- Name: Markus Schneider, MD
- Phone Number: 00492119191605
- Email: markus.schneider@evk-duesseldorf.de
Study Locations
-
-
-
Dusseldorf, Germany, 40217
- Evangelisches Krankenhaus
-
Contact:
- Torsten Beyna, MD
- Phone Number: 00492119191605
- Email: Torsten.Beyna@evk-duesseldorf.de
-
Sub-Investigator:
- Horst Neuhaus, MD
-
Principal Investigator:
- Markus Schneider, 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
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with surgically altered upper gastrointestinal anatomy and indication for endoscopic retrograde cholangio-pancreatography
Description
Inclusion Criteria:
- altered upper gastrointestinal anatomy after Billroth-II- or Roux-en-Y reconstructive surgery
- indication for ERCP with biliary and/or pancreatic indication
- Enteroscopy-assisted ERCP using MSE, at the study center during the study period
Exclusion Criteria:
- due to the retrospective design of the study, no exclusion criteria are defined
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
MSE-ERCP
Group of patients, that received motorized spiral enteroscopy assisted ERCP in altered anatomy at the single study center
|
No interventional study, MSE-ERCP performed within routine treatment, (approved indication of device)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Success rate of MSE-ERCP
Time Frame: intraprocedural
|
rate of subjects with successfull MSE-assisted ERCP
|
intraprocedural
|
|
Adverse event rate of MSE-ERCP
Time Frame: 3 days
|
rate of adverse events during and early after MSE-ERCP
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Success rate of enteroscopy
Time Frame: intraprocedural
|
rate of subjects with successful enteroscopic access to the papilla
|
intraprocedural
|
|
Procedural duration
Time Frame: intraprocedural
|
overall time for MSE-ERCP (scope in to scope out)
|
intraprocedural
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Torsten Beyna, MD PhD, Evangelisches Krankenhaus Düsseldorf, Department of Gastroenterology and Therapeutic Endoscopy
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 (ANTICIPATED)
June 1, 2021
Primary Completion (ANTICIPATED)
September 1, 2021
Study Completion (ANTICIPATED)
October 1, 2021
Study Registration Dates
First Submitted
May 28, 2021
First Submitted That Met QC Criteria
May 28, 2021
First Posted (ACTUAL)
June 3, 2021
Study Record Updates
Last Update Posted (ACTUAL)
June 21, 2021
Last Update Submitted That Met QC Criteria
June 18, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EVK-PSE-ERCP RETRO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No exchange of individual data is planned
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.