Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis

NCT ID: NCT02590978

Last Updated: 2018-09-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-01
• Study Completion Date: 2017-11-01

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.

Conditions

Gallstone Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early cholecystectomy

Cholecystectomy within the first 72 hours of admission.

Group Type: EXPERIMENTAL

Early cholecystectomy

Intervention Type: PROCEDURE

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.

Group Type: OTHER

Control (Delayed cholecystectomy)

Intervention Type: PROCEDURE

Standard care arm. Cholecystectomy + intraoperative cholangiography is delayed once complete resolution of abdominal tenderness, oral feeding and trending down in pancreatic laboratory is achieved

Interventions

Early cholecystectomy

Cholecystectomy + intraoperative cholangiography within the first 72 hours of admission.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital del Salvador

OTHER

Sponsor Role: lead

Responsible Party

FRANCISCO RIQUELME

SURGEON

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francisco Riquelme, M.D.

Role: PRINCIPAL_INVESTIGATOR

Universidad de Chile- Hospital del Salvador

Locations

Boris Marinkovic

Santiago, Santiago Metropolitan, Chile

Countries

Chile

References

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Reference Type: BACKGROUND

PMID: 18636298 (View on PubMed)

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Gurusamy KS, Nagendran M, Davidson BR. Early versus delayed laparoscopic cholecystectomy for acute gallstone pancreatitis. Cochrane Database Syst Rev. 2013 Sep 2;2013(9):CD010326. doi: 10.1002/14651858.CD010326.pub2.

Reference Type: BACKGROUND

PMID: 23996398 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24756933 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23100216 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31235428 (View on PubMed)

Other Identifiers

CPPAL-2015

Identifier Type: -

Identifier Source: org_study_id