NCT04467710

Brief Summary

The aim of this study was to identify some risk factors of failure of surgical management of common bile duct stones, in our center between 2007 and 2019.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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, 2007

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
Last Updated

September 3, 2020

Status Verified

July 1, 2020

Enrollment Period

13 years

First QC Date

July 8, 2020

Last Update Submit

September 1, 2020

Conditions

LaparoscopicCommon Bile Duct Stone With Chronic Cholecystitis

Keywords

Common bile duct stonesLaparoscopic common bile duct exploration (LCBDE)ERCPMorbimortality

Outcome Measures

Primary Outcomes (1)

  • morbimortality

    Clavien dindo classification

    1 day

Secondary Outcomes (1)

  • risk factors of total laprascopic treatment failure.

    1 day

Study Arms (2)

Success of LCBDE

Patients with a fully laparoscopic surgical treatment of common bile duct stones

Procedure: Laparoscopic common bile duct exploration.

Failure of LCBDE

Patients with a laparoscopic cholecystectomy but an endoscopic treatment of common bile duct stone with an ERCP performed intra, per or postoperatively

Procedure: Laparoscopic common bile duct exploration.

Interventions

Laparoscopic common bile duct exploration.PROCEDURE

Laparoscopic common bile duct exploration. ERCP (Endoscopic Retrograde Cholangiopancreatography) with sphincterotomy : : removal of common bile duct stones trought the cystic duct (transcystically) with a Dormia or a choledoscope, or throught the common bile duct with a choledoscope introduced throught an incision of the common bile duct. ERCP with sphincterotomy: removal of common bile duct stones throught the duodenal papilla, and a sphincterotomy of the oddi sphincter during the same time.

Failure of LCBDESuccess of LCBDE

Eligibility Criteria

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

All patients aged more than 18, hospitalized in Montpellier University Hospital between 2007 and 2019 requiring a laparoscopic cholecystectomy for symptomatic biliary disease associated to a common bile duct stone highlighted on preoperative imaging or intraoperative cholangiography, which will be treated surgically or endoscopically during the same hospital stay.

You may qualify if:

  • More than 18 years old
  • Between 2007 and 2019
  • Montpellier University Hospital
  • Laparoscopic cholecystectomy for symptomatic cholelithiasis associated to common bile duct stones
  • Common bile duct stones highlighted on preoperative imaging or intraoperative cholangiography
  • Common bile duct stones treated during the same hospital stay surgically or endocopically

You may not qualify if:

  • Laparotomy
  • Previous ERCP
  • Less than 18 years old
  • Lost to follow up
  • Lack of data \> 10%
  • Other surgical procedure associated at the same time
  • Previous cholecystectomy
  • Caroli's disease
  • Severe cholangitis or acute pancreatitis
  • Pigmentary or hydatic lithiasis
  • Laparoscopic cholecystectomy for other indication than symptomatic cholelithiasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Related Publications (1)

  • Genet D, Souche R, Roucaute S, Borie F, Millat B, Valats JC, Fabre JM, Herrero A. Upfront Laparoscopic Management of Common Bile Duct Stones: What Are the Risk Factors of Failure? J Gastrointest Surg. 2023 Sep;27(9):1846-1854. doi: 10.1007/s11605-023-05687-9. Epub 2023 Apr 27.

    PMID: 37106206DERIVED

Study Officials

  • Astrid HERRERO, MD, PHD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 13, 2020

Study Start

January 1, 2007

Primary Completion

December 30, 2019

Study Completion

June 1, 2020

Last Updated

September 3, 2020

Record last verified: 2020-07

Locations

FR(1)