Safety of early oral refeeding in patients with chronic pancreatitis after extracorporeal shock wave lithotripsy of pancreatic stone (SHEEL): A multicenter randomized controlled trial.

BACKGROUND Fasting after extracorporeal shock wave lithotripsy (ESWL) is often used to avoid pancreas injury and reduce risk of pancreatitis. However, the optimal timing of oral refeeding after ESWL remains unclear. This study evaluates the impact of early oral refeeding on post-ESWL pancreatitis. METHODS This multicenter randomized controlled trial was conducted at six centers in China. Patients without complications at 6 hours after ESWL were randomly assigned (1:1) to the 6-hour fasting or 24-hour fasting group. Patients in the 6-hour fasting group started oral intake at 6 hours after ESWL, whereas those in the 24-hour fasting group fasted for 24 hours after ESWL. The primary outcome was post-ESWL pancreatitis, analysed on the intention-to-treat principle. RESULTS Between May 2023, and April 2024, 216 patients were enrolled, with 107 patients randomly assigned to the 6-hour fasting group and 109 patients to the 24-hour fasting group. Post-ESWL pancreatitis occurred in 2 (1.9%) of 107 patients assigned to the 6-hour fasting group and in 3 (2.8%) of 109 patients assigned to the 24-hour fasting group (risk difference -0.9%, 95% confidence interval -6.1 to 4.2). There were no differences between the two groups in post-ESWL pancreatitis, severity of post-ESWL pancreatitis, other complications and transient adverse events. Additionally, the incidences of abdominal discomfort and hunger were significantly lower in 6-hour fasting than 24-hour fasting group. Among all post-ESWL pancreatitis, 80.8% of post-ESWL pancreatitis occurred within 6 hours after ESWL. DISCUSSION Early oral refeeding in patients after ESWL was safe and did not increase the incidence of post-ESWL pancreatitis. This was also associated with reduced abdominal discomfort and hunger. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT05669573.