Prophylaxis of Post-ERCP Acute Pancreatitis — PEPPER  

Pancreatitis, Acute Clinical Trial

Official title: Prophylaxis of Post-ERCP Acute Pancreatitis: a Randomized, Multicenter, Open-label Study Comparing Indomethacin Versus Indomethacin-ringer Lactate Combination

Status Recruiting

Clinical Trial Summary

This study aims to compare indomethacin and the combination of indomethacin and aggressive lactated Ringer infusion in terms of efficacy in preventing post-ERCP acute pancreatitis (PEP).

Clinical Trial Description

This study aims to compare indomethacin and the combination of indomethacin and aggressive lactated Ringer infusion in terms of their efficacy in preventing PEP regardless of baseline risk in all eligible patients who have consecutively undergone ERCP. The intention is to confirm initial literature finding with a large sample size and a prospective, randomised, multicentre design to study and compare the efficacy of the two different prophylaxis strategies. The interest is determined by the need to assess whether there is a superiority of combination prophylaxis with indomethacin and a strong infusion of lactated Ringer against the exclusive administration of endorectal indomethacin, with a consequent considerable impact on the management of PEP. Shouldn't forget that both indomethacin and lactated Ringer have in the various studies only reduced the incidence of PEP compared to placebo. Therefore, PEP remains a possible complication even after prophylaxis with a single measure, even in low-risk patients. If the study demonstrates the superiority of combination prophylaxis, it could offer this to all patients with gains in PEP, hospitalisation, and complication management costs.

It should be noted that, compared with previous studies, this protocol doesn't include a placebo control arm. This choice, shared by all the centres involved, is dictated by the awareness that literature studies have already documented the superiority of both indomethacin and Ringer's lactate in PEP prophylaxis compared to placebo. Moreover, although some studies raise doubts about the prophylactic efficacy of indomethacin in low-risk patients, it was decided not to include a placebo arm because of ethical misgivings about not proposing a treatment with a low risk of side events, as recommended moreover by international guidelines.

Finally, the study aims to assess the occurrence of any adverse events in the two groups studied. ;

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Acute

• NCT number: NCT05381428
• Study type: Interventional
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: Vincenzo Giorgio Mirante, MD
• Phone: +390522242910
• Email: vincenzogiorgio.mirante@ausl.re.it
• Status: Recruiting
• Phase: Phase 3
• Start date: May 13, 2022
• Completion date: February 2025