Statins and Post-ERCP Acute Pancreatitis (Stark Project)

NCT06367322 | Completed

• 1 other identifier: EMP-PARA-20170-01
• Study Type: observational
• Target: 1,016
• Locations: 1 country
• Sites: 2

Brief Summary

Post-endoscopic retrograde cholangiopancrepatography (ERCP) acute pancreatitis (PEAP) is a frequent complication of this endoscopic procedure. Chronic statin intake has been linked to lower incidence and severity of acute pancreatitis (AP). Periprocedural rectal administration of non-steroidal anti-inflammatory drugs is protective against PEP, but the role of chronic acetylsalicylic acid (ASA) treatment is unclear. The aim of the study is to investigate whether statins and chronic ASA intake are associated with lower risk of PEAP.

Conditions

Post-ERCP Acute Pancreatitis

Keywords

Endoscopic retrograde cholangiopancreatography; Hydroxymethylglutaryl-Coenzyme A reductase inhibitors; Statin; Salicylates; Acute Pancreatitis; Prevention

Outcome Measures

Primary Outcomes (1)

• To assess the incidence and relative risk of PEAP according to statin use.

  The primary outcome was to compare the incidence and relative risk of PEAP between users of statins and non-users of statins. Subgroup analysis included type of statin and dosing and the consumption of statins the night before the procedure.

  2 years

Secondary Outcomes (2)

• To assess the effect of chronic use of other drugs on the incidence and relative risk of PEAP.

  2 years

• To assess the effect of other factors (demographic and endoscopic) on the incidence and relative risk of PEAP and severity of PEAP (severity according to the Revised Atlanta Classification).

  2 years

Study Arms (2)

Statin users

Patients ≥ 18 years old scheduled for ERCP according to a medical indication, and willing to participate were included, who were receiving treatment with statins. Excluded: patients with ongoing AP, surgically altered biliary anatomy (such as hepatico-jejunostomy or choledoco-duodenostomy), or failure to reach the papilla as well as patients undergoing ERCP for stent removal or exchange were excluded.

Drug: Statin

Non-statin users

Patients ≥ 18 years old scheduled for ERCP according to a medical indication, and willing to participate were included, who were not receiving treatment with statins. Excluded: patients with ongoing AP, surgically altered biliary anatomy (such as hepatico-jejunostomy or choledoco-duodenostomy), or failure to reach the papilla as well as patients undergoing ERCP for stent removal or exchange were excluded.

Interventions

Statin DRUG

The primary objective of this study was to determine whether the use of statin has a protective effect against PEAP. Patients undergoing ERCP for a specific medical indication were prospectively reviewed and the incidence of PEAP was compared according to whether or not the patients were receiving statin therapy.

Statin users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from seven tertiary centers in five European countries (Spain, Italy, Croatia, Finland, and Sweden), consecutively undergoing ERCP according to medical indication, over 18 years old, were prospectively recruited and investigated on their demographic characteristics, comorbidities, consumption of statins and other drugs, outcome of the endoscopic procedure and development of post-procedure complications (specifically PEAP).

You may qualify if:

• Patients ≥ 18 years old scheduled for ERCP and willing to participate were included.

You may not qualify if:

• Patients with ongoing AP
• Surgically altered biliary anatomy (such as hepatico-jejunostomy or choledoco-duodenostomy)
• Failure to reach the papilla
• Patients undergoing ERCP for stent removal or exchange

Sponsors & Collaborators

• Hospital General Universitario de Alicante: lead
• European Pancreatic Club (EPC), Pancreas 2000 Educational Program: collaborator

Study Sites (2)

Alicante

Alicante, 03010, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Related Publications (8)

• Dumonceau JM, Andriulli A, Elmunzer BJ, Mariani A, Meister T, Deviere J, Marek T, Baron TH, Hassan C, Testoni PA, Kapral C; European Society of Gastrointestinal Endoscopy. Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - updated June 2014. Endoscopy. 2014 Sep;46(9):799-815. doi: 10.1055/s-0034-1377875. Epub 2014 Aug 22.

  PMID: 25148137 BACKGROUND

• Wu BU, Pandol SJ, Liu IL. Simvastatin is associated with reduced risk of acute pancreatitis: findings from a regional integrated healthcare system. Gut. 2015 Jan;64(1):133-8. doi: 10.1136/gutjnl-2013-306564. Epub 2014 Apr 17.

  PMID: 24742713 BACKGROUND

• Anagnostopoulos GK, Tsiakos S, Margantinis G, Kostopoulos P, Arvanitidis D. Acute pancreatitis due to pravastatin therapy. JOP. 2003 May;4(3):129-32.

  PMID: 12743419 BACKGROUND

• Preiss D, Tikkanen MJ, Welsh P, Ford I, Lovato LC, Elam MB, LaRosa JC, DeMicco DA, Colhoun HM, Goldenberg I, Murphy MJ, MacDonald TM, Pedersen TR, Keech AC, Ridker PM, Kjekshus J, Sattar N, McMurray JJ. Lipid-modifying therapies and risk of pancreatitis: a meta-analysis. JAMA. 2012 Aug 22;308(8):804-11. doi: 10.1001/jama.2012.8439.

  PMID: 22910758 BACKGROUND

• Thisted H, Jacobsen J, Munk EM, Norgaard B, Friis S, McLaughlin JK, Sorensen HT, Johnsen SP. Statins and the risk of acute pancreatitis: a population-based case-control study. Aliment Pharmacol Ther. 2006 Jan 1;23(1):185-90. doi: 10.1111/j.1365-2036.2006.02728.x.

  PMID: 16393296 BACKGROUND

• Gornik I, Gasparovic V, Gubarev Vrdoljak N, Haxiu A, Vucelic B. Prior statin therapy is associated with milder course and better outcome in acute pancreatitis--a cohort study. Pancreatology. 2013 May-Jun;13(3):196-200. doi: 10.1016/j.pan.2013.03.008. Epub 2013 Mar 14.

  PMID: 23719587 BACKGROUND

• Wei L, Yamamoto M, Harada M, Otsuki M. Treatment with pravastatin attenuates progression of chronic pancreatitis in rat. Lab Invest. 2011 Jun;91(6):872-84. doi: 10.1038/labinvest.2011.41. Epub 2011 Mar 7.

  PMID: 21383674 BACKGROUND

• Almeida JL, Sampietre SN, Mendonca Coelho AM, Trindade Molan NA, Machado MC, Monteiro da Cunha JE, Jukemura J. Statin pretreatment in experimental acute pancreatitis. JOP. 2008 Jul 10;9(4):431-9.

  PMID: 18648134 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD. Associate Professor of Miguel Hernández University. Research Deputy Director of Alicante Institute for Health and Biomedical Research (acronyms in Spanish: ISABIAL).

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 16, 2024
• Study Start: January 10, 2017
• Primary Completion: July 31, 2018
• Study Completion: September 30, 2018
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

ES (2)