MedTrace Logo

Feasibility and Safety of Bile Duct Clearance by Transcystic Sphincter of Oddi Balloon Dilatation

NCT04737642 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2023-01-26

No results posted yet for this study

Summary

To investigate feasibility and safety of intraoperative bile duct clearance by sphincter of Oddi balloon dilatation via cystic duct at cholecystectomy.

Primary endpoint: rate of successful bile duct stone clearance (feasibility). Secondary endpoints (safety): rate of peri-interventional complications (injury to the common bile duct, bleeding, injury to surrounding organs: stomach, duodenum, liver) and short-term postoperative complications (bile leak, cholangitis, lipasaemia, pancreatitis, pneumonia). Duration of procedure. Length of hospital stay.

Conditions

  • Cholecystolithiasis
  • Choledocholithiasis
  • Surgery

Interventions

PROCEDURE

Papillary ballon dilatation

Trans cystic papillary ballon dilatation during cholecystectomy

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Beat Schnüriger, Prof · UVCM, Inselspital Bern

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2022-07-01
Completion
2022-10-09

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04737642 on ClinicalTrials.gov