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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

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.

Condition or disease Intervention/treatment Phase
Gallstone Pancreatitis Procedure: Early cholecystectomy Procedure: Control (Delayed cholecystectomy) Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis: A Randomized Prospective Study
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early cholecystectomy
Cholecystectomy within the first 72 hours of admission.
Procedure: Early cholecystectomy
Cholecystectomy + intraoperative cholangiography within the first 72 hours of admission.

Control (Delayed cholecystectomy)
Standard care arm. Cholecystectomy is delayed until normalization of laboratory values, abdominal pain resolves and oral intake is restored.
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




Primary Outcome Measures :
  1. Length of Stay (LOS) [ Time Frame: 90 dias ]
    days


Secondary Outcome Measures :
  1. Endoscopic retrograde cholangio-pancreatography (ERCP) [ Time Frame: 90 days ]
    yes/no

  2. Conversion [ Time Frame: surgery ]
    yes/no

  3. Wound infection [ Time Frame: 30 days ]
    yes/no

  4. Re-admission [ Time Frame: 90 days ]
    yes/no

  5. Biliary complications [ Time Frame: 90 days ]
    biloma, bile leak, residual choledocholithiasis

  6. Operative time [ Time Frame: surgery ]
    operative time in minutes

  7. medical complications [ Time Frame: 30 days ]
    any medical complication using Clavien-dindo classification



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590978


Locations
Chile
Boris Marinkovic
Santiago, Región Metropolitana, Chile
Sponsors and Collaborators
Hospital del Salvador
Investigators
Principal Investigator: Francisco Riquelme, M.D. Universidad de Chile- Hospital del Salvador

Additional Information:
Publications:

Responsible Party: FRANCISCO RIQUELME, SURGEON, Hospital del Salvador
ClinicalTrials.gov Identifier: NCT02590978     History of Changes
Other Study ID Numbers: CPPAL-2015
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: December 2015

Keywords provided by FRANCISCO RIQUELME, Hospital del Salvador:
gallstone pancreatitis
mild acute pancreatitis
adult

Additional relevant MeSH terms:
Pancreatitis
Gallstones
Cholelithiasis
Cholecystolithiasis
Pancreatic Diseases
Digestive System Diseases
Biliary Tract Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical