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
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 Type
OBSERVATIONAL
Enrollment
35
No interventional study, MSE-ERCP performed within routine treatment, (approved indication of device)
Evangelisches Krankenhaus
Düsseldorf, Germany
Success rate of MSE-ERCP
rate of subjects with successfull MSE-assisted ERCP
Time frame: intraprocedural
Adverse event rate of MSE-ERCP
rate of adverse events during and early after MSE-ERCP
Time frame: 3 days
Success rate of enteroscopy
rate of subjects with successful enteroscopic access to the papilla
Time frame: intraprocedural
Procedural duration
overall time for MSE-ERCP (scope in to scope out)
Time frame: intraprocedural
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