Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy

NCT ID: NCT01492790

Last Updated: 2013-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-08-31

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.

Detailed Description

Emergency cholecystectomy is nowadays an accepted surgical procedure routinely performed worldwide. The main indications include acute cholecystitis, cholangitis and gallstone migration. Abnormal liver function tests upon admission and suspicion for accompanying common bile duct (CBD) stone can delay the surgical management due to the need for further investigations and/or therapeutic maneuvers. These procedures include magnetic resonance cholangio-pancreatography (MRCP), endoscopic ultrasound (EUS) and endoscopic retrograde cholangio-pancreatography (ERCP).

While useful to detect or exclude potential CBD stones, these procedures include inherent risks, delay the surgical treatment, extend hospital stay and as a result, increase the overall medical costs. They can also potentially increase the morbidity and/or mortality by delaying emergency cholecystectomy (due to the presence of more local inflammation and adherence). Finally, more and more centers perform systematic intra-operative cholangiogram during cholecystectomies (laparoscopic or open), which allow an accurate assessment of the CBD and potentially lead to its subsequent exploration (endoscopic or surgical).

In this study, the investigators will assess the following hypotheses:

• Patients with a SUSPICION of gallstone migration (with or without associated cholecystitis) should undergo emergency cholecystectomy with intra-operative cholangiogram (IOC) first
• "Cholecystectomy first" strategy will decrease both the length of hospital stay and the morbidity/mortality by decreasing the number of unnecessary EUS, MRCP and ERCP and therefore decreasing the overall number of their complications, as well as decreasing the complications related to delayed cholecystectomy (increased adherences due to inflammation, especially in case of associated cholecystitis, which increase the risk of bleeding, CBD lesion, duodenal lesion, gastric lesion, colon lesion, gallbladder perforation and intra-abdominal gallstones spillage with potential

Conditions

Cholelithiasis; Cholecystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cholecystectomy first

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

Group Type: EXPERIMENTAL

Emergency cholecystectomy first

Intervention Type: PROCEDURE

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

Sequential common bile duct imaging/cholecystectomy

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

Group Type: ACTIVE_COMPARATOR

Sequential common bile duct imaging/cholecystectomy

Intervention Type: PROCEDURE

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

Interventions

Emergency cholecystectomy first

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

Intervention Type: PROCEDURE

Sequential common bile duct imaging/cholecystectomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients must have a clinical diagnosis of gallstone migration, defined as right upper quadrant or epigastric abdominal pain and abnormal liver function tests (increase of at least two common hepatic parameters [AST, ALT, alkaline phosphatase, gGT and/or bilirubin], with one of them being either AST or ALT with a value at least two times higher than the norm) with a reasonable exclusion of other common differential diagnoses
• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Pouya Iranmanesh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pouya Iranmanesh, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Geneva University Hospitals

Geneva, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 25005650 (View on PubMed)

Other Identifiers

CER 11-045 (NAC 11-012)

Identifier Type: -

Identifier Source: org_study_id