NCT04690101

Brief Summary

There are three treatment options for choledocholithiasis: endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy; laparoscopic exploration of the main bile duct with concomitant cholecystectomy; and open cholecystectomy with exploration of the main bile duct. A retrospective, descriptive, observational study was taken of patients with a diagnosis of cholecystocholedocholithiasis that failed ERCP and who underwent laparoscopic cholecystectomy with exploration of the bile duct.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

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 31, 2009

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

9.8 years

First QC Date

December 22, 2020

Last Update Submit

December 27, 2020

Conditions

Choledocholithiasis

Outcome Measures

Primary Outcomes (1)

  • TREATMENT OF CHOLEDOCOLITHIASIS

    TREATMENT OF CHOLEDOCOLITHIASIS AFTER FAILED ENDOSCOPIC CHOLANGIOPANCREATOGRAPHY

    2009-2018

Interventions

none, this is an observational studyOTHER

none, this is an observational study

Eligibility Criteria

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

patients with a diagnosis of cholecyto-choledocholithiasis with failed ERCP and who were taken to LCDE in the General Surgery service of the General Ignacio Zaragoza

You may qualify if:

  • Patients with a diagnosis of cholecyto-choledocholithiasis with failed ERCP and who were taken to LCDE in the General Surgery service

You may not qualify if:

  • Less than 18 year old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Choledocholithiasis

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasis

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 30, 2020

Study Start

January 31, 2009

Primary Completion

December 1, 2018

Study Completion

November 30, 2020

Last Updated

December 30, 2020

Record last verified: 2020-12