Motorized Spiral Enteroscopy-assisted ERCP in Surgically Altered Anatomy

NCT ID: NCT04912440

Last Updated: 2021-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-30

Study Completion Date

2021-10-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Ercp in Altered Anatomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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MSE-ERCP

Group of patients, that received motorized spiral enteroscopy assisted ERCP in altered anatomy at the single study center

MSE-ERCP

Intervention Type DEVICE

No interventional study, MSE-ERCP performed within routine treatment, (approved indication of device)

Interventions

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MSE-ERCP

No interventional study, MSE-ERCP performed within routine treatment, (approved indication of device)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Evangelisches Krankenhaus Düsseldorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Torsten Beyna, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Evangelisches Krankenhaus Düsseldorf, Department of Gastroenterology and Therapeutic Endoscopy

Locations

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Evangelisches Krankenhaus

Düsseldorf, , Germany

Site Status

Countries

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Germany

Central Contacts

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Torsten Beyna, MD PhD

Role: CONTACT

00492119191605

Markus Schneider, MD

Role: CONTACT

00492119191605

Facility Contacts

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Torsten Beyna, MD

Role: primary

00492119191605

Other Identifiers

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EVK-PSE-ERCP RETRO

Identifier Type: -

Identifier Source: org_study_id

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