NCT02461147

Brief Summary

Initial cholecystectomy with intraoperative cholangiogram, followed if required by ERCP, has been implemented at the investigators institution as the standard management strategy for patients at intermediate risk of common bile duct stone migration, following a randomized controlled trial previously published by the same investigators team. The aim of this study is to prospectively analyze the outcomes of this strategy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Typical duration 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

September 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

2.3 years

First QC Date

January 19, 2015

Last Update Submit

November 2, 2020

Conditions

CholedocholithiasisGallstone MigrationCholecystitisGallstone PancreatitisCholangitis

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay [days]

    1-100 days

Secondary Outcomes (3)

  • Number of common bile duct investigations [N]

    Anytime during hospital stay, an expected average of 7 days

  • Common bile duct clearance rate [%]

    This outcome will be assessed after each ERCP performed during hospital stay, an expected average of 7 days

  • Morbidity

    From admission up to 6 months after hospital discharge

Study Arms (1)

Validation cohort

All patients of the study (single group, single arm) will undergo initial cholecystectomy with intraoperative cholangiogram, followed if required by ERCP, according to the standard protocol of treatment previously implemented at the investigators institution.

Procedure: Cholecystectomy with intraoperative cholangiogram

Interventions

Cholecystectomy with intraoperative cholangiogramPROCEDURE

cf. arm/group description. This intervention is not assigned by the investigators: it is the standard treatment at the investigators institution.

Validation cohort

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted through the emergency department for an acute gallstone-related condition.

You may qualify if:

  • Admission through emergency department for an acute gallstone-related condition (cholecystitis, gallstone pancreatitis, ascending cholangitis, suspicion of gallstone migration, choledocholithiasis)

You may not qualify if:

  • Severe sepsis or septic shock
  • contra-indication to surgery
  • previous surgery interfering with common bile duct assessment procedures (roux-en-y gastric bypass, etc.)
  • previous cholecystectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospital

Geneva, 1205, Switzerland

Location

Related Publications (3)

  • Iranmanesh P, Frossard JL, Mugnier-Konrad B, Morel P, Majno P, Nguyen-Tang T, Berney T, Mentha G, Toso C. Initial cholecystectomy vs sequential common duct endoscopic assessment and subsequent cholecystectomy for suspected gallstone migration: a randomized clinical trial. JAMA. 2014 Jul;312(2):137-44. doi: 10.1001/jama.2014.7587.

    PMID: 25005650RESULT

  • Iranmanesh P, Frossard JL, Toso C. Treatment for patients at intermediate risk of a common duct stone--reply. JAMA. 2014 Nov 19;312(19):2043-4. doi: 10.1001/jama.2014.13425. No abstract available.

    PMID: 25399287RESULT

  • Iranmanesh P, Frossard JL, Toso C. Reply: To PMID 25451658. Gastroenterology. 2015 Jan;148(1):252. doi: 10.1053/j.gastro.2014.11.016. Epub 2014 Nov 21. No abstract available.

    PMID: 25451659RESULT

MeSH Terms

Conditions

CholedocholithiasisCholecystitisCholangitis

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasisGallbladder Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Pouya Iranmanesh, MD

    Geneva University Hospital, Division of Digestive Surgery

    PRINCIPAL INVESTIGATOR

  • Christian Toso, MD-PhD

    Geneva University Hospital, Division of Digestive Surgery

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 19, 2015

First Posted

June 3, 2015

Study Start

September 1, 2013

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

CH(1)