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Endoscopic Retrograde Cholangiopancreatography Access and Complication Rates After Cholecystectomy With Common Bile Duct Stones

ConditionCommon Bile Duct Stones
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska Institutet

About this trial

The aim of this retrospective, register-based study is to investigate whether access, or no access, to endoscopic retrograde cholangiopancreatography (ERCP) at a surgical unit is associated with the risk of complications in patients undergoing laparoscopic cholecystectomy with common bile duct stones detected on intraoperative cholangiography.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years old

Laparoscopic cholecystectomy with common bile duct stones (CBDS) detected on intraoperative cholangiography (IOC)

Procedure registered in the Swedish Registry for Gallstone Surgery and ERCP (GallRiks) 2015-2025

Disqualifiers

Open surgery

Conversion to open surgery

Transgastric ERCP

Trial population

Patients, ≥18 years old, undergoing laparoscopic cholecystectomy with common bile duct stones detected on intraoperative cholangiography in Sweden 2015-2025 and registered in GallRiks.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Exposed group

    Other intervention

    The exposed group consists of patients undergoing laparoscopic and diagnosed with CBDS during cholecystectomy at a unit where ERCP is not available.

Treatment groups

10,000 Participants
are divided into 2 treatment groups
Group A: Cholecystectomy without access to endoscopic retrograde cholangiopancreatography (ERCP)1 intervention
Group B: Cholecystectomy with access to ERCP0 interventions

Trial outcomes

Primary outcomes

1

Complications

Overall complications from both the cholecystectomy and the endoscopic retrograde cholangiopancreatography (ERCP).

Time frame
0- 30 days from the cholecystectomy, 0-30 days from any performed ERCP

Secondary outcomes

1

Length of hospital stay

Length of hospital stay for cholecystecomy plus ERCP

Time frame
0-100 days from the cholecystectomy, 0-100 days from any performed ERCP
2

Time from cholecystectomy to first treatment of common bile duct stones

Time from cholecystectomy to first treatment of common bile duct stones (days)

Time frame
0-100 days from the cholecystectomy
3

Unplanned ERCP after surgery due to CBDS

Unplanned ERCP after treatment of CBDS

Time frame
1-365 days
4

Unplanned readmission

Unplanned readmission (yes or no)

Time frame
0- 30 days from the cholecystectomy, 0-30 days from any performed ERCP

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: