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Gallstone PancreatitisNCT02590978

Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis

A study testing Early cholecystectomy in people with Gallstone Pancreatitis, run by Hospital del Salvador at 1 site in Chile.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gallstone Pancreatitis
What is being tested?
Early cholecystectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChile
Study dates
1 Dec 2015to 1 Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Boris Marinkovic

    Santiago, Santiago Metropolitan

Other trials in Chile

About this study

Official title: Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis: A Randomized Prospective Study

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.

Read the 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.

Being tested
Early cholecystectomy, Control (Delayed cholecystectomy)
Keywords
gallstone pancreatitis, mild acute pancreatitis, adult

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early cholecystectomyProcedure or surgery

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

  • Control (Delayed cholecystectomy)Procedure or surgery

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

Study groups in NCT02590978
Study groupRoleWhat they receive
Early cholecystectomyExperimentalCholecystectomy within the first 72 hours of admission.
Receives: Procedure: Early cholecystectomy
Control (Delayed cholecystectomy)OtherStandard care arm. Cholecystectomy is delayed until normalization of laboratory values, abdominal pain resolves and oral intake is restored.
Receives: Procedure: Control (Delayed cholecystectomy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of Stay (LOS)

    days

    Measured: 90 dias

Secondary outcomes (7)

  1. Endoscopic retrograde cholangio-pancreatography (ERCP)

    yes/no

    Measured: 90 days

  2. Conversion

    yes/no

    Measured: surgery

  3. Wound infection

    yes/no

    Measured: 30 days

  4. Re-admission

    yes/no

    Measured: 90 days

  5. Biliary complications

    biloma, bile leak, residual choledocholithiasis

    Measured: 90 days

  6. Operative time

    operative time in minutes

    Measured: surgery

  7. medical complications

    any medical complication using Clavien-dindo classification

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2015 (estimated)
  2. Study start1 Dec 2015
  3. Primary completion1 Nov 2017
  4. Study completion1 Nov 2017

Why it stopped: Interim analysis (n=52) with significantly differences in primary outcome (LOS)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02590978
Sponsor's protocol ID
CPPAL-2015
Status last verified
Dec 2015
First submitted
27 Oct 2015
Last updated
17 Sep 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18636298

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

    PubMed 3175860

  • 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.

    PubMed 22470079

  • 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.

    PubMed 15333174

  • 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.

    PubMed 20101174

  • 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.

    PubMed 24099593

  • 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.

    PubMed 23996398

  • 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.

    PubMed 24756933

  • 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.

    PubMed 23100216

  • 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.

    PubMed 31235428

Questions about this trial

What is this clinical trial studying?

A study testing Early cholecystectomy in people with Gallstone Pancreatitis, run by Hospital del Salvador at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Interim analysis (n=52) with significantly differences in primary outcome (LOS)). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of Stay (LOS) (time frame: 90 dias). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02590978, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.

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