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

Study Contact Backup

Study Locations

  • Germany
      • Dusseldorf, Germany, 40217
        • Evangelisches Krankenhaus
        • Contact:
        • 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
Device: MSE-ERCP
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.

Sponsor

Evangelisches Krankenhaus Düsseldorf

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.

General Publications

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.

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