Simvastatin in the Prevention of Recurrent Pancreatitis

• Status: Recruiting
• Trial end date: 2022-09-28
• Target enrollment: 0
• Participant gender: All

Summary

Recurrent acute pancreatitis and recurrent relapses of inflammation in chronic pancreatitis are an important problem. In some cases, prevention of these acute flares of inflammation is not possible. Population-based studies and meta-analysis of randomized controlled trials suggest that statins may decrease the incidence of acute pancreatitis. SIMBA aims to investigate the effect of simvastatin on the incidence of new episodes of pancreatitis in recurrent acute pancreatitis and chronic pancreatitis. This is a non-profit, researcher-driven placebo-controlled multicenter (27 Spanish centers) randomized controlled trial

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Enrique de-Madaria
• Collaborators: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana; Generalitat Valenciana; Instituto de Salud Carlos III
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

1. Adult (>=18) patients

2. At least 2 episodes of acute pancreatitis or acute flares of chronic pancreatitis

3. Written consent to participate in the study

Exclusion Criteria:

1. <2 episodes of pancreatitis in the last 12 months.

2. Statin consumption in the previous year.

3. Contraindications to the use of Statins

4. Cholelithiasis or choledocholitiasis diagnosed in the last episode of pancreatitis

5. Endoscopic sphyncterotomy and/or cholecystectomy and/or pancreatic surgery between last episode of AP and recruitment or patients who are expected to undergo one of this techniques in less than a year.

6. Serum triglycerides >500 mg/dL without previous specific treatment before the last episode of pancreatitis, or in patients expected to have a change in their specific hypertriglyceridemia treatment in less than 1 year

7. Primary hyperparathyroidism that has been operated between last episode of pancreatitis and recruitment or will be operated in less than 1 year

8. Iatrogenic Pancreatitis

9. Abstinence syndrome due to alcohol or drugs and/or delirium tremens in the last 6 months before recruitment

10. Previous (last year) failure to attend follow-up medical visits, social problems that may be associated to failure to take the medication or to perform an adequate follow-up

11. Pregnancy, breastfeeding