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Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis

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ClinicalTrials.gov Identifier: NCT02590978
Recruitment Status : Terminated (Interim analysis (n=52) with significantly differences in primary outcome (LOS))
First Posted : October 29, 2015
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
FRANCISCO RIQUELME, Hospital del Salvador

Tracking Information
First Submitted Date  ICMJE October 27, 2015
First Posted Date  ICMJE October 29, 2015
Last Update Posted Date September 17, 2018
Actual Study Start Date  ICMJE December 1, 2015
Actual Primary Completion Date November 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
Length of Stay (LOS) [ Time Frame: 90 dias ]
days
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2015)
hospital stay [ Time Frame: Through study completion (approximately two years) ]
Change History Complete list of historical versions of study NCT02590978 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
  • Endoscopic retrograde cholangio-pancreatography (ERCP) [ Time Frame: 90 days ]
    yes/no
  • Conversion [ Time Frame: surgery ]
    yes/no
  • Wound infection [ Time Frame: 30 days ]
    yes/no
  • Re-admission [ Time Frame: 90 days ]
    yes/no
  • Biliary complications [ Time Frame: 90 days ]
    biloma, bile leak, residual choledocholithiasis
  • Operative time [ Time Frame: surgery ]
    operative time in minutes
  • medical complications [ Time Frame: 30 days ]
    any medical complication using Clavien-dindo classification
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2015)
perioperative complications [ Time Frame: within 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis
Official Title  ICMJE Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis: A Randomized Prospective Study
Brief Summary Randomized controlled trial to demonstrate the safety of early cholecystectomy (<72h) in patients with mild gallstone pancreatitis. The purpose of this study is to demonstrate that there is a shorter hospital stay and no higher complication rates.
Detailed Description

Acute pancreatitis is a prevalent disease, responsible for 220.000 hospital admissions per year in the United States of America. In Chile, during year 2012 there were 76.463 hospital admissions for this diagnosis, with a mean hospital stay of 11,8 days and 25 deaths per year associated with this disease (250 deaths from 2002 to 2012). The most frequent etiology of pancreatitis in Chile is gallstones, which can be present in 80% of the patients admitted for acute pancreatitis. This can be explained by the high prevalence of gallstones among these patients.

Since Acosta and Ledesma demonstrated the association between gallstones and acute pancreatitis in 1974, cholecystectomy has been the most efficient treatment option to prevent recurrence that can reach even 30-40% in the first two weeks after the first episode. There is consensus in delaying the time of the cholecystectomy in patients with acute gallstone pancreatitis where mortality can be as high as 80% in patients presenting with severe cases. However, the vast majority of the patients will present with a mild pancreatitis requiring no more than basic medical support. In these patients, the role of surgery during the same hospital admission has been clearly demonstrated.

There is no current consensus with respect to the safety of performing cholecystectomy in patients with mild pancreatitis within 48 to 72 hours after the hospital admission. There are few well-designed observational studies and only one randomized clinical trial, which has demonstrated a significant decrease in hospital stay (7 to 4 days), without increasing the rate of complications or mortality. According to some models of analysis and decision, this strategy could reduce costs associated with prolonged hospital stays and improve the quality of life of these patients without jeopardizing patient safety.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gallstone Pancreatitis
Intervention  ICMJE
  • Procedure: Early cholecystectomy
    Cholecystectomy + intraoperative cholangiography within the first 72 hours of admission.
  • Procedure: Control (Delayed cholecystectomy)
    Standard care arm. Cholecystectomy + intraoperative cholangiography is delayed once complete resolution of abdominal tenderness, oral feeding and trending down in pancreatic laboratory is achieved
Study Arms  ICMJE
  • Experimental: Early cholecystectomy
    Cholecystectomy within the first 72 hours of admission.
    Intervention: Procedure: Early cholecystectomy
  • Control (Delayed cholecystectomy)
    Standard care arm. Cholecystectomy is delayed until normalization of laboratory values, abdominal pain resolves and oral intake is restored.
    Intervention: Procedure: Control (Delayed cholecystectomy)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 13, 2018)
52
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2015)
100
Actual Study Completion Date  ICMJE November 1, 2017
Actual Primary Completion Date November 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Patients aged 18-70 years admitted with first gallstone acute pancreatitis (GAP) is evaluated for eligibility. Diagnosis and severity of GAP is based upon Atlanta Consensus modified at 2012. Acute pancreatitis is diagnosed when at least two out of three criteria are met; acute upper abdominal pain, elevated serum amylase/lipase level (more than thrice upper limit of normal range) and evidence of pancreatitis at any imaging modality (abdominal ultrasonography, computed tomography or magnetic resonance image). Biliary etiology is verified by abdominal ultrasonography showing stones or sludge at gallbladder. All other etiologies should be excluded. Exclusions criteria: (1) acute cholecystitis at abdominal ultrasonography, (2) suspected or confirmed acute cholangitis according to 2013 Tokyo Guidelines (fever or laboratory data with inflammatory response, cholestasis and imaging study with biliary dilatation/evident etiology), (3) history of Roux en Y gastric by pass or open supraumbilical surgery, (4) acute alcohol consumption, (5) chronic hepatic/pancreatic disease, (6) comorbidities contraindicating emergency surgery, (7) mental condition that preclude informed consent, (8) pregnancy, (9) patient refusal, (10) no endoscopist availability. There is no exclusions based on choledocolithiasis risk. All patients must complete clinical, anthropometric, and general laboratory/liver function tests at admission and daily until third day of stay or surgery.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02590978
Other Study ID Numbers  ICMJE CPPAL-2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party FRANCISCO RIQUELME, Hospital del Salvador
Study Sponsor  ICMJE Hospital del Salvador
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francisco Riquelme, M.D. Universidad de Chile- Hospital del Salvador
PRS Account Hospital del Salvador
Verification Date December 2015

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