NCT02155244

Brief Summary

In unfit elderly people with comorbid disease leaving the gallbladder in situ is justified after ERCP treatment. Cholangitis is more present in elderly people. The purpose of this study is to determine leaving the gallbladder in situ does not reduce the morbidity rate after ERCP for common bile duct stones(CBDS), especially in patients with cholangitis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
Last Updated

June 4, 2014

Status Verified

June 1, 2014

Enrollment Period

8 years

First QC Date

May 19, 2014

Last Update Submit

June 3, 2014

Conditions

Common Bile Duct Stones

Keywords

CBDSERCPDindo-Clavien classification

Outcome Measures

Primary Outcomes (1)

  • Post-operative complications according to Clavien-Dindo classification

    During patients hospitalization (median hospital stay was 9 days)

Study Arms (2)

Common bile duct stones

Common bile duct stones traeted with ERCP

CBDS

treated with ERCP combined with surgery

Eligibility Criteria

Age18 Years - 94 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • \- Patients with common bile duct stones (CBDS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 19, 2014

First Posted

June 4, 2014

Study Start

January 1, 2006

Primary Completion

January 1, 2014

Study Completion

May 1, 2014

Last Updated

June 4, 2014

Record last verified: 2014-06