Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy

Brief Title

Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy

Official Title

An Open Randomized Study Comparing Emergency Cholecystectomy First Versus Sequential Common Bile Duct Imaging/Cholecystectomy for the Management of Gallstone Migration

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
    

Study Type

Interventional

Primary Outcome

Hospital stay [days]

Secondary Outcome

 Morbidity

Condition

Cholelithiasis

Intervention

Emergency cholecystectomy first

Study Arms / Comparison Groups

 Cholecystectomy first

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Procedure

Estimated Enrollment

100

Start Date

June 2011

Completion Date

August 2013

Primary Completion Date

February 2013

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)
      

Gender

All

Ages

16 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pouya Iranmanesh, MD, , 

Location Countries

Switzerland

Location Countries

Switzerland

NCT ID

NCT01492790

Organization ID

CER 11-045 (NAC 11-012)

Responsible Party

Principal Investigator

Study Sponsor

University Hospital, Geneva

Study Sponsor

Pouya Iranmanesh, MD, Principal Investigator, University Hospital, Geneva

Verification Date

August 2013