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
|Condition or disease||Intervention/treatment||Phase|
|Gallstone Pancreatitis||Procedure: Early cholecystectomy Procedure: Control (Delayed cholecystectomy)||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Length of Stay (LOS) [ Time Frame: 90 dias ]days
- 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
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
|Santiago, Región Metropolitana, Chile|
|Principal Investigator:||Francisco Riquelme, M.D.||Universidad de Chile- Hospital del Salvador|