NCT02590978

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

September 17, 2018

Status Verified

December 1, 2015

Enrollment Period

1.9 years

First QC Date

October 27, 2015

Last Update Submit

September 13, 2018

Conditions

Gallstone Pancreatitis

Keywords

gallstone pancreatitismild acute pancreatitisadult

Outcome Measures

Primary Outcomes (1)

  • Length of Stay (LOS)

    days

    90 dias

Secondary Outcomes (7)

  • Endoscopic retrograde cholangio-pancreatography (ERCP)

    90 days

  • Conversion

    surgery

  • Wound infection

    30 days

  • Re-admission

    90 days

  • Biliary complications

    90 days

  • +2 more secondary outcomes

Study Arms (2)

Early cholecystectomy

EXPERIMENTAL

Cholecystectomy within the first 72 hours of admission.

Procedure: Early cholecystectomy

Control (Delayed cholecystectomy)

OTHER

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

Procedure: Control (Delayed cholecystectomy)

Interventions

Early cholecystectomyPROCEDURE

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

Early cholecystectomy
Control (Delayed cholecystectomy)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

Control (Delayed cholecystectomy)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Boris Marinkovic

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (10)

  • Ito K, Ito H, Whang EE. Timing of cholecystectomy for biliary pancreatitis: do the data support current guidelines? J Gastrointest Surg. 2008 Dec;12(12):2164-70. doi: 10.1007/s11605-008-0603-y. Epub 2008 Jul 18.

    PMID: 18636298BACKGROUND

  • Kelly TR, Wagner DS. Gallstone pancreatitis: a prospective randomized trial of the timing of surgery. Surgery. 1988 Oct;104(4):600-5.

    PMID: 3175860BACKGROUND

  • 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.

    PMID: 22470079BACKGROUND

  • 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.

    PMID: 15333174BACKGROUND

  • 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.

    PMID: 20101174BACKGROUND

  • 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.

    PMID: 24099593BACKGROUND

  • 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.

    PMID: 23996398BACKGROUND

  • 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.

    PMID: 24756933BACKGROUND

  • 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.

    PMID: 23100216BACKGROUND

  • 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.

    PMID: 31235428DERIVED

Related Links

Study Officials

  • Francisco Riquelme, M.D.

    Universidad de Chile- Hospital del Salvador

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SURGEON

Study Record Dates

First Submitted

October 27, 2015

First Posted

October 29, 2015

Study Start

December 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

September 17, 2018

Record last verified: 2015-12

Locations

CL(1)