Motorized Spiral Enteroscopy-assisted ERCP in Surgically Altered Anatomy

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04912440

Enrollment

Registered

2021-06-03

Start date

2021-06-30

Completion date

2021-10-31

Last updated

2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ercp in Altered Anatomy

Keywords

endoscopy, enteroscopy, ercp in altered anatomy

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.

Interventions

DEVICEMSE-ERCP

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Contacts

Primary ContactTorsten Beyna, MD PhD

torsten.beyna@evk-duesseldorf.de00492119191605

Backup ContactMarkus Schneider, MD

markus.schneider@evk-duesseldorf.de00492119191605

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026