Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy

NCT01492790 | Completed

• 1 other identifier: CER 11-045 (NAC 11-012)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate if cholecystectomy first (studied group) versus sequential common bile duct imaging/cholecystectomy (control group) result in a decrease of hospital stay, morbidity/mortality and costs in the management of patients with a suspicion of gallstone migration.

Conditions

Cholelithiasis; Cholecystitis

Outcome Measures

Primary Outcomes (1)

• Hospital stay [days]

  We will evaluate if our "new treatment" arm will have a decreased hospital stay. We do not expect patients to stay more than 30 days.

  0 - 30 days

Secondary Outcomes (2)

• Morbidity

  6 months

• Mortality

  6 months

Study Arms (2)

Cholecystectomy first

EXPERIMENTAL

Patients enrolled in this arm will undergo emergency cholecystectomy first without any common bile duct imaging

Procedure: Emergency cholecystectomy first

Sequential common bile duct imaging/cholecystectomy

ACTIVE COMPARATOR

Patients enrolled in this arm will undergo common bile duct imaging and, if needed, ERCP first followed by emergency cholecystectomy

Procedure: Sequential common bile duct imaging/cholecystectomy

Interventions

Emergency cholecystectomy first PROCEDURE

The intervention is an emergency cholecystectomy without prior common bile duct imaging

Cholecystectomy first

Sequential common bile duct imaging/cholecystectomy PROCEDURE

This intervention is a common bile duct imaging modality and, if needed, ERCP first followed in the same hospital stay by a cholecystectomy

Sequential common bile duct imaging/cholecystectomy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be included regardless the presence of an associated cholecystitis, defined as right upper quadrant abdominal pain, radiological signs of cholecystitis (including radiological Murphy sign and/or thickened gallbladder wall and/or free abdominal fluid around the gallbladder) and signs of infection (including fever, increased CRP or white blood cell count)
• Age ≥ 16 years

You may not qualify if:

• Presence of CBD stone on CT or US performed on admission (which will require ERCP exploration prior to surgery)
• Associated radiologically proven gallstone pancreatitis
• Associated cholangitis
• Medical conditions preventing surgery such as acute stroke, acute coronary syndrome, severe cardiac failure (NYHA class IV and/or respiratory failure with SpO2 \< 85% with room air and/or LVEF \< 35%), severe COPD with VEMS \< 30 % of predicted value
• Medical conditions preventing informed consent
• Patients with contraindications to MRI (MRI-incompatible electronic devices \[e.g. pacemakers\], implants or prostheses, vascular clips less than 2 weeks, severe claustrophobia) and to EUS/ERCP (surgery with gastric diversion, severe cardiac dysfunction)

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1211, Switzerland

Location

Related Publications (1)

• 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: 25005650 DERIVED

MeSH Terms

Conditions

Cholelithiasis; Cholecystitis

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Pouya Iranmanesh, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 15, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

CH (1)