Motorized Spiral Enteroscopy-assisted ERCP in Surgically Altered Anatomy

Evangelisches Krankenhaus Düsseldorf

Status: Unknown

Conditions: Ercp in Altered Anatomy

Treatments: Device: MSE-ERCP

Study type: Observational

Funder types: Other

Identifiers

NCT04912440

EVK-PSE-ERCP RETRO

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

35 participants in 1 patient group

MSE-ERCP

Description:

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

Treatment:

Device: MSE-ERCP