Acute PancreatitisCHISPANCT06113419

Timing of CHolecystectomy In Severe PAncreatitis

A study testing Laparoscopic cholecystectomy in people with Acute Pancreatitis and Cholelithiasis, run by Hospital Universitario Mayor Méderi at 2 sites in Colombia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The goal of this clinical trial is to compare outcomes for interval or early laparoscopic cholecystectomy in patients with moderately severe and severe pancreatitis. The main question[s] it aims to answer are: To establish whether there is a difference in surgical outcomes comparing patients diagnosed with severe or… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Pancreatitis, Cholelithiasis
What is being tested?: Laparoscopic cholecystectomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 134 participants
Where: 2 sitesColombia
Study dates: 1 Apr 2024to Jul 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥18 years, diagnosis of pancreatitis according to Atlanta guidelines, moderately severe or severe pancreatitis (APACHE score ≥8 on admittance)
Biliary pancreatitis diagnosed on imaging (be it ultrasound, magnetic resonance imaging and/or tomography)
Recovery of pancreatitis by tolerance of oral intake (defined as 24 hours of food consumption of any consistency without emetic episodes and pain defined as 4/10 on the visual analogue score of pain) and written informed consent.

Who cannot join

Pregnancy
History of cholecystectomy
Planned open cholecystectomy
Pancreatitis-associated complication before laparoscopic cholecystectomy (compartment syndrome, bleeding and/or need for peripancreatic collection drainage)
Chronic pancreatitis,
More than one episode of pancreatitis

Show all 9Show fewer

Active malignant disease
Septic shock
Choledocholithiasis not resolved by ERCP, post-ERCP perforation and post-ERCP concomitant pancreatitis.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Camilo Ramírez-Giraldo, MD contact

+5773206770474

ramirezgiraldocamilo@gmail.com

Colombia2 sites, 2 recruiting

Hospital Universitario Mayor-Méderi
Bogota, Cundinamarca, 111221
Camilo Ramírez-Giraldo, 57 3206770474, ramirezgiraldocamilo@gmail.com
Recruiting
Hospital Universitario Méderi Barrios Unidos
Bogota, Cundinamarca, 111221
Isabella Van, 3206955392, isabellavanl@gmail.com
Recruiting

Other trials in Colombia

About this study

Official title: Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): Study Protocol for a Randomized Controlled Trial.

To establish whether there is a difference in surgical outcomes comparing patients diagnosed with severe or moderately severe pancreatitis on which early cholecystectomy was performed versus performing interval cholecystectomy.
The primary endpoint will be to evaluate major complications, defined as a Clavien-Dindo score greater than or equal to III/V.
Secondary endpoints include evaluating minor complications (defined as a Clavien-Dindo score below III/V), biliary disease recurrence, mortality, postoperative hospital stay and postoperative admittance into an intensive care unit.

Participants will be randomly assigned to either group: early cholecystectomy during the pancreatitis hospitalization or interval cholecystectomy scheduled 4 weeks after clinical resolution of pancreatitis.

Read the detailed description

CHISPA is a randomized controlled, parallel-group, superiority clinical trial. An intention- to-treat analysis will be performed. It seeks to evaluate differences between patients taken to early cholecystectomy during hospital admission (72 hours after randomization) versus delayed cholecystectomy (30 +/- 5 days after randomization). Primary endpoint is major complications associated to laparoscopic cholecystectomy defined as a Clavien-Dindo score of over III/V during the first 90 days after the procedure. Secondary endpoints include recurrence of biliary disease, mortality, minor complications (Clavien-Dindo score below III/V), days of postoperative hospital stay, and days admitted in an intensive care unit postoperatively.

Conditions: Acute Pancreatitis, Cholelithiasis
Being tested: Laparoscopic cholecystectomy
Keywords: cholecystectomy, Acute Pancreatitis, Cholelithiasis
Medical subject headings: Pancreatitis, Cholelithiasis

What participants receive

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

Laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy will be performed using the standard American 4-port technique, insufflation will be achieved using CO2 to 15mmHg of pressure. Calot's triangle will be dissected until the critical view of safety is reached, being careful to dissect above the R4U line. After reaching the critical view of safety, two proximal and one distal clip will be placed on both the cystic conduct and artery separately, cutting the clips and then dissecting the gallbladder in a cystfundic direction. When the critical view of safety is not reached, the surgeon may perform a fundus-first cholecystectomy, subtotal cholecystectomy, conversion to open procedure, intraoperative cholangiography or cholecystostomy to their own discretion. It will also be the surgeon's criteria to employ or not a drain system in the surgical site. The decision for theses interventions will be taken intraoperatively and will be according to findings during the procedure.

Study groups in NCT06113419
Study group	Role	What they receive
Early cholecystectomy	Experimental	Early laparoscopic cholecystectomy (within 72 hours after randomization) Receives: Procedure: Laparoscopic cholecystectomy
Interval cholecystectomy	Active comparator	Interval laparoscopic cholecystectomy (30 +/- 5 days after randomization). Receives: Procedure: Laparoscopic cholecystectomy

What is being measured

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

Major complications (rates)
Clavien-Dindo score III in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy
Measured: 90 days
Major complications (rates)
Clavien-Dindo score IV in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy
Measured: 90 days
Major complications (rates)
Clavien-Dindo score V in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy
Measured: 90 days

Secondary outcomes (5)

Recurrence (rates)
Biliary disease recurrence defined as a new admission for recurrent pancreatitis, cholecystitis, cholangitis, choledocholithiasis, need fro ERCP or biliary colic previous to the surgical procedure until 90 postoperative days after it
Measured: 90 days
Mortality (rates)
Determine differences in mortality between patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy
Measured: 90 days
Postoperative hospital stay length (days; median)
Compare differences in postoperative hospital stay length (general) in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy
Measured: 90 days
Minor complications (rates)
Clavien-Dindo score I-II in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy
Measured: 90 days
Postoperative stay length in the ICU (days; median)
Compare differences in postoperative stay length in the ICU in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy
Measured: 90 days

Timeline

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

1 Apr 2024Jul 2027

First posted2 Nov 2023
Study start1 Apr 2024
Primary completionApr 2027 (estimated)
Study completionJul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Acute PancreatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Model description: CHISPA is a randomized controlled, parallel-group, superiority clinical trial. Patients will be randomly allocated to receive early laparoscopic cholecystectomy (within 72 hours after randomization) or interval laparoscopic cholecystectomy (30 +/- 5 days after randomization).
Masking: None (open label)
Enrolment: 134 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06113419
Sponsor's protocol ID: 2022-26-02B
Other IDs: DVO005 2456-CV1683
Acronym: CHISPA
Status last verified: Oct 2026
First submitted: 27 Oct 2023
Last updated: 22 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data obtained and input into the database is anonymous, without any individual or identifying characteristics will be stored in a dataset from the Centro de Recursos para el Aprendizaje y la Investigación, property of and administered by the Universidad del Rosario as a plan of data management. Moreover, the different codes used in the analysis will be stored in this dataset.

Publications

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
Yokoe M, Takada T, Mayumi T, Yoshida M, Isaji S, Wada K, Itoi T, Sata N, Gabata T, Igarashi H, Kataoka K, Hirota M, Kadoya M, Kitamura N, Kimura Y, Kiriyama S, Shirai K, Hattori T, Takeda K, Takeyama Y, Hirota M, Sekimoto M, Shikata S, Arata S, Hirata K. Japanese guidelines for the management of acute pancreatitis: Japanese Guidelines 2015. J Hepatobiliary Pancreat Sci. 2015 Jun;22(6):405-32. doi: 10.1002/jhbp.259. Epub 2015 May 13.
PubMed 25973947
Leppaniemi A, Tolonen M, Tarasconi A, Segovia-Lohse H, Gamberini E, Kirkpatrick AW, Ball CG, Parry N, Sartelli M, Wolbrink D, van Goor H, Baiocchi G, Ansaloni L, Biffl W, Coccolini F, Di Saverio S, Kluger Y, Moore E, Catena F. 2019 WSES guidelines for the management of severe acute pancreatitis. World J Emerg Surg. 2019 Jun 13;14:27. doi: 10.1186/s13017-019-0247-0. eCollection 2019.
PubMed 31210778
Prasanth J, Prasad M, Mahapatra SJ, Krishna A, Prakash O, Garg PK, Bansal VK. Early Versus Delayed Cholecystectomy for Acute Biliary Pancreatitis: A Systematic Review and Meta-Analysis. World J Surg. 2022 Jun;46(6):1359-1375. doi: 10.1007/s00268-022-06501-4. Epub 2022 Mar 19.
PubMed 35306590
Forsmark CE, Vege SS, Wilcox CM. Acute Pancreatitis. N Engl J Med. 2016 Nov 17;375(20):1972-1981. doi: 10.1056/NEJMra1505202.
PubMed 27959604
Nealon WH, Bawduniak J, Walser EM. Appropriate timing of cholecystectomy in patients who present with moderate to severe gallstone-associated acute pancreatitis with peripancreatic fluid collections. Ann Surg. 2004 Jun;239(6):741-9; discussion 749-51. doi: 10.1097/01.sla.0000128688.97556.94.
PubMed 15166953
Ackermann TG, Cashin PA, Alwan M, Wewelwala CC, Tan D, Vu AN, Bowers KA, Berry R, Croagh DG. The Role of Laparoscopic Cholecystectomy After Severe and/or Necrotic Pancreatitis in the Setting of Modern Minimally Invasive Management of Pancreatic Necrosis. Pancreas. 2020 Aug;49(7):935-940. doi: 10.1097/MPA.0000000000001601.
PubMed 32658078
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542
Gupta V, Jain G. Safe laparoscopic cholecystectomy: Adoption of universal culture of safety in cholecystectomy. World J Gastrointest Surg. 2019 Feb 27;11(2):62-84. doi: 10.4240/wjgs.v11.i2.62.
PubMed 30842813
Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.
PubMed 24054878
Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
PubMed 23896955
Li J, Chen J, Tang W. The consensus of integrative diagnosis and treatment of acute pancreatitis-2017. J Evid Based Med. 2019 Feb;12(1):76-88. doi: 10.1111/jebm.12342.
PubMed 30806495
Sun W, An LY, Bao XD, Qi YX, Yang T, Li R, Zheng SY, Sun DL. Consensus and controversy among severe pancreatitis surgery guidelines: a guideline evaluation based on the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool. Gland Surg. 2020 Oct;9(5):1551-1563. doi: 10.21037/gs-20-444.
PubMed 33224831
Hughes DL, Morris-Stiff G. Determining the optimal time interval for cholecystectomy in moderate to severe gallstone pancreatitis: A systematic review of published evidence. Int J Surg. 2020 Dec;84:171-179. doi: 10.1016/j.ijsu.2020.11.016. Epub 2020 Nov 20.
PubMed 33227531
da Costa DW, Bouwense SA, Schepers NJ, Besselink MG, van Santvoort HC, van Brunschot S, Bakker OJ, Bollen TL, Dejong CH, van Goor H, Boermeester MA, Bruno MJ, van Eijck CH, Timmer R, Weusten BL, Consten EC, Brink MA, Spanier BWM, Bilgen EJS, Nieuwenhuijs VB, Hofker HS, Rosman C, Voorburg AM, Bosscha K, van Duijvendijk P, Gerritsen JJ, Heisterkamp J, de Hingh IH, Witteman BJ, Kruyt PM, Scheepers JJ, Molenaar IQ, Schaapherder AF, Manusama ER, van der Waaij LA, van Unen J, Dijkgraaf MG, van Ramshorst B, Gooszen HG, Boerma D; Dutch Pancreatitis Study Group. Same-admission versus interval cholecystectomy for mild gallstone pancreatitis (PONCHO): a multicentre randomised controlled trial. Lancet. 2015 Sep 26;386(10000):1261-1268. doi: 10.1016/S0140-6736(15)00274-3.
PubMed 26460661

Interested in taking part?

Camilo Ramírez-Giraldo, MD

+5773206770474

ramirezgiraldocamilo@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): Study Protocol for a Randomized Controlled Trial.
ClinicalTrials.gov ID: NCT06113419
Acronym / sponsor ID: CHISPA / 2022-26-02B
Conditions: Acute Pancreatitis, Cholelithiasis
Keywords: cholecystectomy, Acute Pancreatitis, Cholelithiasis
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 134 participants (estimated)
Lead sponsor: Hospital Universitario Mayor MéderiUniversity, hospital or other
Collaborators: Universidad del Rosario
Study start: 1 Apr 2024 (actual)
Primary completion: Apr 2027 (estimated)
Study completion: Jul 2027 (estimated)
First posted: 2 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To establish whether there is a difference in surgical outcomes comparing patients diagnosed with severe or moderately severe pancreatitis on which early cholecystectomy was performed versus performing interval cholecystectomy.
The primary endpoint will be to evaluate major complications, defined as a Clavien-Dindo score greater than or equal to III/V.
Secondary endpoints include evaluating minor complications (defined as a Clavien-Dindo score below III/V), biliary disease recurrence, mortality, postoperative hospital stay and postoperative admittance into an intensive care unit.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: CHISPA is a randomized controlled, parallel-group, superiority clinical trial. Patients will be randomly allocated to receive early laparoscopic cholecystectomy (within 72 hours after randomization) or interval laparoscopic cholecystectomy (30 +/- 5 days after randomization).

Arm	Type	Receives
Early cholecystectomy	Experimental	Procedure: Laparoscopic cholecystectomyEarly laparoscopic cholecystectomy (within 72 hours after randomization)
Interval cholecystectomy	Active comparator	Procedure: Laparoscopic cholecystectomyInterval laparoscopic cholecystectomy (30 +/- 5 days after randomization).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age ≥18 years, diagnosis of pancreatitis according to Atlanta guidelines, moderately severe or severe pancreatitis (APACHE score ≥8 on admittance)
Biliary pancreatitis diagnosed on imaging (be it ultrasound, magnetic resonance imaging and/or tomography)
Recovery of pancreatitis by tolerance of oral intake (defined as 24 hours of food consumption of any consistency without emetic episodes and pain defined as 4/10 on the visual analogue score of pain) and written informed consent.

Key exclusion criteria (9 listed)

Pregnancy
History of cholecystectomy
Planned open cholecystectomy
Pancreatitis-associated complication before laparoscopic cholecystectomy (compartment syndrome, bleeding and/or need for peripancreatic collection drainage)
Chronic pancreatitis,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Laparoscopic cholecystectomyLaparoscopic cholecystectomy will be performed using the standard American 4-port technique, insufflation will be achieved using CO2 to 15mmHg of pressure. Calot's triangle will be dissected until the critical view of safety is reached, being careful to dissect above the R4U line. After reaching the critical view of safety, two proximal and one distal clip will be placed on both the cystic conduct and artery separately, cutting the clips and then dissecting the gallbladder in a cystfundic direction. When the critical view of safety is not reached, the surgeon may perform a fundus-first cholecystectomy, subtotal cholecystectomy, conversion to open procedure, intraoperative cholangiography or cholecystostomy to their own discretion. It will also be the surgeon's criteria to employ or not a drain system in the surgical site. The decision for theses interventions will be taken intraoperatively and will be according to findings during the procedure.	Procedure or surgery	Early cholecystectomy, Interval cholecystectomy

Primary outcome

Major complications (rates)
Time frame: 90 days
Clavien-Dindo score III in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy
Major complications (rates)
Time frame: 90 days
Clavien-Dindo score IV in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy
Major complications (rates)
Time frame: 90 days
Clavien-Dindo score V in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy

5 secondary outcomes

Recurrence (rates)
Time frame: 90 days
Mortality (rates)
Time frame: 90 days
Postoperative hospital stay length (days; median)
Time frame: 90 days
Minor complications (rates)
Time frame: 90 days
Postoperative stay length in the ICU (days; median)
Time frame: 90 days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
Background: PubMed 23100216Banks 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.
Background: PubMed 25973947Yokoe M, Takada T, Mayumi T, Yoshida M, Isaji S, Wada K, Itoi T, Sata N, Gabata T, Igarashi H, Kataoka K, Hirota M, Kadoya M, Kitamura N, Kimura Y, Kiriyama S, Shirai K, Hattori T, Takeda K, Takeyama Y, Hirota M, Sekimoto M, Shikata S, Arata S, Hirata K. Japanese guidelines for the management of acute pancreatitis: Japanese Guidelines 2015. J Hepatobiliary Pancreat Sci. 2015 Jun;22(6):405-32. doi: 10.1002/jhbp.259. Epub 2015 May 13.
Background: PubMed 31210778Leppaniemi A, Tolonen M, Tarasconi A, Segovia-Lohse H, Gamberini E, Kirkpatrick AW, Ball CG, Parry N, Sartelli M, Wolbrink D, van Goor H, Baiocchi G, Ansaloni L, Biffl W, Coccolini F, Di Saverio S, Kluger Y, Moore E, Catena F. 2019 WSES guidelines for the management of severe acute pancreatitis. World J Emerg Surg. 2019 Jun 13;14:27. doi: 10.1186/s13017-019-0247-0. eCollection 2019.
Background: PubMed 35306590Prasanth J, Prasad M, Mahapatra SJ, Krishna A, Prakash O, Garg PK, Bansal VK. Early Versus Delayed Cholecystectomy for Acute Biliary Pancreatitis: A Systematic Review and Meta-Analysis. World J Surg. 2022 Jun;46(6):1359-1375. doi: 10.1007/s00268-022-06501-4. Epub 2022 Mar 19.
Background: PubMed 27959604Forsmark CE, Vege SS, Wilcox CM. Acute Pancreatitis. N Engl J Med. 2016 Nov 17;375(20):1972-1981. doi: 10.1056/NEJMra1505202.
Background: PubMed 15166953Nealon WH, Bawduniak J, Walser EM. Appropriate timing of cholecystectomy in patients who present with moderate to severe gallstone-associated acute pancreatitis with peripancreatic fluid collections. Ann Surg. 2004 Jun;239(6):741-9; discussion 749-51. doi: 10.1097/01.sla.0000128688.97556.94.
Background: PubMed 32658078Ackermann TG, Cashin PA, Alwan M, Wewelwala CC, Tan D, Vu AN, Bowers KA, Berry R, Croagh DG. The Role of Laparoscopic Cholecystectomy After Severe and/or Necrotic Pancreatitis in the Setting of Modern Minimally Invasive Management of Pancreatic Necrosis. Pancreas. 2020 Aug;49(7):935-940. doi: 10.1097/MPA.0000000000001601.
Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
Background: PubMed 30842813Gupta V, Jain G. Safe laparoscopic cholecystectomy: Adoption of universal culture of safety in cholecystectomy. World J Gastrointest Surg. 2019 Feb 27;11(2):62-84. doi: 10.4240/wjgs.v11.i2.62.
Background: PubMed 24054878Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.
Background: PubMed 23896955Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
Background: PubMed 30806495Li J, Chen J, Tang W. The consensus of integrative diagnosis and treatment of acute pancreatitis-2017. J Evid Based Med. 2019 Feb;12(1):76-88. doi: 10.1111/jebm.12342.
Individual participant dataSharing planned: Yes. Data obtained and input into the database is anonymous, without any individual or identifying characteristics will be stored in a dataset from the Centro de Recursos para el Aprendizaje y la Investigación, property of and administered by the Universidad del Rosario as a plan of data management. Moreover, the different codes used in the analysis will be stored in this dataset.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Camilo Ramírez-Giraldo, MD contact

+5773206770474

ramirezgiraldocamilo@gmail.com

Camilo Ramirez-Giraldo, MD principal investigator

Hospital Universitario Mayor Méderi

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic cholecystectomy in people with Acute Pancreatitis and Cholelithiasis, run by Hospital Universitario Mayor Méderi at 2 sites in Colombia.

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

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Colombia. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Camilo Ramírez-Giraldo, MD (+5773206770474, ramirezgiraldocamilo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major complications (rates) (time frame: 90 days). The study lists 3 primary outcomes in all. 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 NCT06113419, which also lists 17 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 22 Oct 2026.