Motorized Spiral Enteroscopy-assisted ERCP in Surgically Altered Anatomy

• Conditions: Ercp in Altered Anatomy
• Interventions: Device: MSE-ERCP

• Registration Number: NCT04912440
• Lead Sponsor: Evangelisches Krankenhaus Düsseldorf

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

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 Timeline

• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-05-28
• Status Verified: 2021-06
• Study Start: 2021-06
• Study First Posted: 2021-06-03
• Last Update Submitted: 2021-06-18
• Last Update Posted: 2021-06-21
• Primary Completion: 2021-09
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Adverse event rate of MSE-ERCP	3 days	rate of adverse events during and early after MSE-ERCP
Success rate of MSE-ERCP	intraprocedural	rate of subjects with successfull MSE-assisted ERCP

Secondary Outcome Measures

Name	Time	Method
Procedural duration	intraprocedural	overall time for MSE-ERCP (scope in to scope out)
Success rate of enteroscopy	intraprocedural	rate of subjects with successful enteroscopic access to the papilla

Trial Locations

Locations (1)

Evangelisches Krankenhaus; 🇩🇪 Dusseldorf, Germany