Motorized Spiral Enteroscopy-assisted ERCP in Surgically Altered Anatomy

NCT04912440 | Unknown

• 1 other identifier: EVK-PSE-ERCP RETRO
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ercp in Altered Anatomy

Keywords

endoscopy; enteroscopy; ercp in altered anatomy

Outcome Measures

Primary Outcomes (2)

• Success rate of MSE-ERCP

  rate of subjects with successfull MSE-assisted ERCP

  intraprocedural

• Adverse event rate of MSE-ERCP

  rate of adverse events during and early after MSE-ERCP

  3 days

Secondary Outcomes (2)

• Success rate of enteroscopy

  intraprocedural

• Procedural duration

  intraprocedural

Study Arms (1)

MSE-ERCP

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

Device: MSE-ERCP

Interventions

MSE-ERCP DEVICE

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

MSE-ERCP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with surgically altered upper gastrointestinal anatomy and indication for endoscopic retrograde cholangio-pancreatography

You may qualify if:

• 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

Sponsors & Collaborators

• Evangelisches Krankenhaus Düsseldorf: lead

Study Sites (1)

Evangelisches Krankenhaus

Düsseldorf, 40217, Germany

Location

Study Officials

• Torsten Beyna, MD PhD

  Evangelisches Krankenhaus Düsseldorf, Department of Gastroenterology and Therapeutic Endoscopy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Torsten Beyna, MD PhD

CONTACT

00492119191605; torsten.beyna@evk-duesseldorf.de

Markus Schneider, MD

CONTACT

00492119191605; markus.schneider@evk-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 3, 2021
• Study Start: June 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)