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DOI: 10.1055/s-0040-1704092
A RANDOMIZED TRIAL OF RECTAL INDOMETHACIN TO PREVENT POST-ESWL PANCREATITIS (THE RIPEP TRIAL)
Publication History
Publication Date:
23 April 2020 (online)
Aims Pancreatic extracorporeal shock wave lithotripsy (ESWL) is the first-line therapy for large pancreatic duct stones, and pancreatitis is the most common complication. Non-steroidal anti-inflammatory drugs (NSAIDs) proved to be an effective prophylactic medication for post-ERCP pancreatitis while little research focused on the incidence and none on the effective prevention for post-ESWL pancreatitis. The aim of the study is to explore the effect of rectal indomethacin for post-ESWL pancreatitis.
Methods In this randomized controlled trial, patients with chronic pancreatitis (CP) and pancreatic stones (> 5 mm in diameter) treated with ESWL at Changhai Hospital were randomly allocated to receive rectal indomethacin or placebo 30 min before the procedure. The primary outcome was the incidence of post-ESWL pancreatitis. The severity of pancreatitis, occurrence of other ESWL-related complications and transient adverse events (TAEs) were also investigated.
Results From May 2016 to July 2019, 1370 patients were prospectively enrolled. The incidence of post-ESWL complications in placebo group was significantly higher than that in patients receiving rectal indomethacin (14.5% vs. 9.5%, P=0.005), with post-ESWL pancreatitis ranked the first in both groups followed by infection (1.9% vs. 0.7%, P=0.058). Rectal indomethacin can greatly reduce the incidence of post-ESWL pancreatitis (12.3% vs. 8.8%, P=0.034), and the incidence decreased significantly with the CP progression. In particular, indomethacin appeared to be protective in female patients with earlier clinical stages, idiopathic, non-type 3c diabetes, intact exocrine pancreatic function and pancreas divisum (all P< 0.05). No difference of other complications and adverse events was observed.
Conclusions Rectal indomethacin can greatly reduce the development of post-ESWL pancreatitis and especially benefit patients at elevated risk. (ClinicalTrials.gov number, NCT02797067.)