Post-endoscopic retrograde cholangiopancreatography pancreatitis: Mechanistic pathways, diagnostic benchmarks, and emerging and mitochondria-targeted therapies

Table 2 Overview of relevant randomized controlled trials

Ref.	Study design	Participants	Intervention	Control	Results
Luo et al[54], 2016	Multicentre, single-blinded, randomised controlled trial	Patients with native papilla undergoing ERCP at six centres in China	All patients received 100 mg rectal indometacin within 30 min before ERCP	High-risk patients received rectal indometacin immediately after ERCP	4% pancreatitis in universal indometacin group vs 8% in risk-stratified group (relative risk = 0.47; 95%CI: 0.34-0.66; P < 0.0001)
Fogel et al[57], 2020	Randomised, double-blind, comparative effectiveness trial	High-risk patients from six tertiary medical centres in the United States	Standard-dose group received two 50 mg indometacin suppositories and a placebo suppository; high-dose group received three 50 mg indometacin suppositories and an additional 50 mg suppository 4 hours after procedure	-	15% pancreatitis in standard-dose group vs 12% in high-dose group (risk ratio = 1.19, 95%CI: 0.87-1.61; P = 0.32)
Mok et al[72], 2017	Randomised, double-blinded, placebo-controlled trial	High-risk patients	Four groups: Normal saline + placebo, normal saline + indometacin, lactated Ringer's + placebo, lactated Ringer's + indometacin	-	6% pancreatitis in lactated Ringer's + indometacin group vs 21% in normal saline + placebo group (P = 0.04)
Patel et al[67], 2022	Randomised controlled trial	High-risk patients	Aggressive infusion of lactated Ringer's or normal saline	-	4% pancreatitis in lactated Ringer's group vs 11% in normal saline group (relative risk = 0.38, 95%CI: 0.10-1.42; P = 0.19)
Concepción-Martín et al[76], 2014	Randomised, double-blind trial	Patients undergoing ERCP at a single centre	Intravenous bolus of somatostatin followed by a 4-hour continuous infusion	Similar placebo regimen	7.5% pancreatitis in somatostatin group vs 6.7% in placebo group (relative risk = 1.12, 95%CI: 0.59-2.1; P = 0.73)
Wang et al[77], 2013	Randomised, placebo-controlled pilot trial	Patients scheduled for ERCP	Pre-ERCP somatostatin (0.5 mg/hour for 24 hours, starting 1 hour before ERCP), post-ERCP somatostatin (0.5 mg/hour for 24 hours, starting 1 hour after ERCP), or placebo (saline for 24 hours, starting 1 hour before ERCP)	-	16.7% pancreatitis in pre-ERCP somatostatin group, 10.6% in post-ERCP somatostatin group, 14.6% in placebo group (P = 0.715)
Norouzi et al[101], 2023	Double-blind randomised placebo-controlled clinical trial	High-risk patients	100 mg rectal indometacin + 250 g somatostatin bolus followed by 500 g infusion for 2 hours	100 mg rectal indometacin + placebo	11.4% pancreatitis in intervention group vs 15.2% in control group (P = 0.666)
Yoo et al[102], 2011	Prospective, randomised, double-blind, controlled trial	Patients undergoing ERCP	Intravenous nafamostat mesilate 60 min before and for 6 hours after ERCP	Placebo	2.8% pancreatitis in nafamostat group vs 9.1% in placebo group (P = 0.03)

ERCP: Endoscopic retrograde cholangiopancreatography.