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Completed

NCT Number: NCT02461147

Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration

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.

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Key information

Conditions

Choledocholithiasis Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholecystitis Cholelithiasis Common Bile Duct Diseases Digestive System Diseases Gallbladder Diseases Gallstone Migration Gallstone Pancreatitis

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geneva University Hospital

Geneva, 1205, Switzerland

About this study

A previous randomized controlled trial comparing initial cholecystectomy with intraoperative cholangiogram (IOC) versus common bile duct (CBD) assessment and subsequent cholecystectomy for patients admitted in the emergency room with an acute gallstone-related condition and with an intermediate risk of common bile duct stone was performed by the investigators. This study had been registered on Clinicaltrials.gov as well and had shown that a strategy with initial cholecystectomy significantly decreased the length of hospital stay and the number of CBD investigations procedures.

Initial cholecystectomy with IOC is now the standard management strategy for these patients in the investigators hospital. The goal of this study is to perform a prospective validation of this strategy and to analyze if the results obtained in the previously mentioned randomized controlled trial are confirmed on a larger patients cohort. This study will be observational, since the intervention (initial cholecystectomy) is not assigned by the investigators, but is already a standard treatment strategy at our institution.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Cholecystectomy with intraoperative cholangiogram

Procedure

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

Primary outcomes

  1. Length of hospital stay [days]

    Time frame: 1-100 days

Secondary outcomes

  1. Number of common bile duct investigations [N]

    Time frame: Anytime during hospital stay, an expected average of 7 days

    These include number of endoscopic ultrasounds (EUS), magnetic cholangio-pancreatography (MRCP) and endoscopic retrograde cholangio-pancreatography (ERCP) performed during the patient's hospital stay

  2. Common bile duct clearance rate [%]

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

    Percentage of patients where common bile duct (CBD) clearance was achieved after ERCP (did not require surgical exploration because of ERCP failure)

  3. Morbidity

    Time frame: From admission up to 6 months after hospital discharge

    Morbidity will be assessed for each patient according to the Dindo-Clavien classification of surgical complications, including death.

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

Initial Cholecystectomy With Intraoperative Cholangiography for Patients at Intermediate Risk of Common Bile Duct Stone Migration : Prospective Validation and Analysis

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 3, 2015
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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