Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis
Primary Purpose
Gallstone Pancreatitis
Status
Terminated
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Early cholecystectomy
Control (Delayed cholecystectomy)
Sponsored by
About this trial
This is an interventional treatment trial for Gallstone Pancreatitis focused on measuring gallstone pancreatitis, mild acute pancreatitis, adult
Eligibility 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.
Sites / Locations
- Boris Marinkovic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Early cholecystectomy
Control (Delayed cholecystectomy)
Arm Description
Cholecystectomy within the first 72 hours of admission.
Standard care arm. Cholecystectomy is delayed until normalization of laboratory values, abdominal pain resolves and oral intake is restored.
Outcomes
Primary Outcome Measures
Length of Stay (LOS)
days
Secondary Outcome Measures
Endoscopic retrograde cholangio-pancreatography (ERCP)
yes/no
Conversion
yes/no
Wound infection
yes/no
Re-admission
yes/no
Biliary complications
biloma, bile leak, residual choledocholithiasis
Operative time
operative time in minutes
medical complications
any medical complication using Clavien-dindo classification
Full Information
NCT ID
NCT02590978
First Posted
October 27, 2015
Last Updated
September 13, 2018
Sponsor
Hospital del Salvador
1. Study Identification
Unique Protocol Identification Number
NCT02590978
Brief Title
Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis
Official Title
Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis: A Randomized Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis (n=52) with significantly differences in primary outcome (LOS)
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
November 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital del Salvador
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstone Pancreatitis
Keywords
gallstone pancreatitis, mild acute pancreatitis, adult
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early cholecystectomy
Arm Type
Experimental
Arm Description
Cholecystectomy within the first 72 hours of admission.
Arm Title
Control (Delayed cholecystectomy)
Arm Type
Other
Arm Description
Standard care arm. Cholecystectomy is delayed until normalization of laboratory values, abdominal pain resolves and oral intake is restored.
Intervention Type
Procedure
Intervention Name(s)
Early cholecystectomy
Intervention Description
Cholecystectomy + intraoperative cholangiography within the first 72 hours of admission.
Intervention Type
Procedure
Intervention Name(s)
Control (Delayed cholecystectomy)
Intervention Description
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 Measure Information:
Title
Length of Stay (LOS)
Description
days
Time Frame
90 dias
Secondary Outcome Measure Information:
Title
Endoscopic retrograde cholangio-pancreatography (ERCP)
Description
yes/no
Time Frame
90 days
Title
Conversion
Description
yes/no
Time Frame
surgery
Title
Wound infection
Description
yes/no
Time Frame
30 days
Title
Re-admission
Description
yes/no
Time Frame
90 days
Title
Biliary complications
Description
biloma, bile leak, residual choledocholithiasis
Time Frame
90 days
Title
Operative time
Description
operative time in minutes
Time Frame
surgery
Title
medical complications
Description
any medical complication using Clavien-dindo classification
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Riquelme, M.D.
Organizational Affiliation
Universidad de Chile- Hospital del Salvador
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boris Marinkovic
City
Santiago
State/Province
Región Metropolitana
Country
Chile
12. IPD Sharing Statement
Citations:
PubMed Identifier
18636298
Citation
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Results Reference
background
PubMed Identifier
3175860
Citation
Kelly TR, Wagner DS. Gallstone pancreatitis: a prospective randomized trial of the timing of surgery. Surgery. 1988 Oct;104(4):600-5.
Results Reference
background
PubMed Identifier
22470079
Citation
van Baal MC, Besselink MG, Bakker OJ, van Santvoort HC, Schaapherder AF, Nieuwenhuijs VB, Gooszen HG, van Ramshorst B, Boerma D; Dutch Pancreatitis Study Group. Timing of cholecystectomy after mild biliary pancreatitis: a systematic review. Ann Surg. 2012 May;255(5):860-6. doi: 10.1097/SLA.0b013e3182507646.
Results Reference
background
PubMed Identifier
15333174
Citation
Cameron DR, Goodman AJ. Delayed cholecystectomy for gallstone pancreatitis: re-admissions and outcomes. Ann R Coll Surg Engl. 2004 Sep;86(5):358-62. doi: 10.1308/147870804227.
Results Reference
background
PubMed Identifier
20101174
Citation
Aboulian A, Chan T, Yaghoubian A, Kaji AH, Putnam B, Neville A, Stabile BE, de Virgilio C. Early cholecystectomy safely decreases hospital stay in patients with mild gallstone pancreatitis: a randomized prospective study. Ann Surg. 2010 Apr;251(4):615-9. doi: 10.1097/SLA.0b013e3181c38f1f.
Results Reference
background
PubMed Identifier
24099593
Citation
Randial Perez LJ, Fernando Parra J, Aldana Dimas G. [The safety of early laparoscopic cholecystectomy (<48 hours) for patients with mild gallstone pancreatitis: a systematic review of the literature and meta-analysis]. Cir Esp. 2014 Feb;92(2):107-13. doi: 10.1016/j.ciresp.2013.01.024. Epub 2013 Oct 4. Spanish.
Results Reference
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PubMed Identifier
23996398
Citation
Gurusamy KS, Nagendran M, Davidson BR. Early versus delayed laparoscopic cholecystectomy for acute gallstone pancreatitis. Cochrane Database Syst Rev. 2013 Sep 2;(9):CD010326. doi: 10.1002/14651858.CD010326.pub2.
Results Reference
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PubMed Identifier
24756933
Citation
Morris S, Gurusamy KS, Patel N, Davidson BR. Cost-effectiveness of early laparoscopic cholecystectomy for mild acute gallstone pancreatitis. Br J Surg. 2014 Jun;101(7):828-35. doi: 10.1002/bjs.9501. Epub 2014 Apr 23.
Results Reference
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PubMed Identifier
23100216
Citation
Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
Results Reference
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PubMed Identifier
31235428
Citation
Riquelme F, Marinkovic B, Salazar M, Martinez W, Catan F, Uribe-Echevarria S, Puelma F, Munoz J, Canals A, Astudillo C, Uribe M. Early laparoscopic cholecystectomy reduces hospital stay in mild gallstone pancreatitis. A randomized controlled trial. HPB (Oxford). 2020 Jan;22(1):26-33. doi: 10.1016/j.hpb.2019.05.013. Epub 2019 Jun 22.
Results Reference
derived
Links:
URL
http://www.minsal.cl/
Description
Ministry of Public Health of Chile
Learn more about this trial
Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis
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