Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy (CCK first)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pouya Iranmanesh, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01492790
First received: December 13, 2011
Last updated: August 12, 2013
Last verified: August 2013

December 13, 2011
August 12, 2013
June 2011
February 2013   (final data collection date for primary outcome measure)
Hospital stay [days] [ Time Frame: 0 - 30 days ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01492790 on ClinicalTrials.gov Archive Site
  • Morbidity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    We will follow-up patients until 6 months after their operation (cholecystectomy) and compare if there is any statistically significant difference between the two arms of the study in terms of morbidity.
  • Mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    We will follow-up patients until 6 months after their operation (cholecystectomy) and compare if there is any statistically significant difference between the two arms of the study in terms of mortality.
Same as current
Not Provided
Not Provided
 
Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy
An Open Randomized Study Comparing Emergency Cholecystectomy First Versus Sequential Common Bile Duct Imaging/Cholecystectomy for the Management of Gallstone Migration

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.

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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cholelithiasis
  • Cholecystitis
  • Procedure: Emergency cholecystectomy first
    The intervention is an emergency cholecystectomy without prior common bile duct imaging
  • 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
  • Experimental: Cholecystectomy first
    Patients enrolled in this arm will undergo emergency cholecystectomy first without any common bile duct imaging
    Intervention: Procedure: Emergency cholecystectomy first
  • Active Comparator: 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
    Intervention: Procedure: Sequential common bile duct imaging/cholecystectomy
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 9;312(2):137-44. doi: 10.1001/jama.2014.7587.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2013
February 2013   (final data collection date for primary outcome measure)

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)
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01492790
CER 11-045 (NAC 11-012)
No
Pouya Iranmanesh, University Hospital, Geneva
University Hospital, Geneva
Not Provided
Principal Investigator: Pouya Iranmanesh, MD University Hospital, Geneva
University Hospital, Geneva
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP