NCT04912440

Motorized Spiral Enteroscopy-assisted ERCP in Surgically Altered Anatomy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 35 (estimated)
• Sponsor: Evangelisches Krankenhaus Düsseldorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ercp in Altered Anatomy

Interventions

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

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-09-01
• Completion: 2021-10-01
• First posted: 2021-06-03
• Last updated: 2021-06-21

Locations

1 site across 1 country: Germany