|
| Study | Year | Country | Type of trial | Patients (T/C) | Intervention | Definition of PEP |
|
| Sotoudehmanesh et al. [14] | 2007 | Iran | Double-blind randomized trial | 245/245 | 100 mg rectal indomethacin versus inert suppository; before ERCP | Serum amylase more than 3 times the upper limit of normal associated with epigastric pain, back pain, and epigastric tenderness |
| Montaño Loza et al. [21] | 2007 | Mexico | Randomized controlled trial | 75/75 | 100 mg rectal indomethacin versus rectal glycerine; before ERCP | Amylase level 3 times the upper limit of normal and epigastric pain or throughout the abdomen radiating to back associated with nausea or vomiting |
| Döbrönte et al. [19] | 2012 | Hungary | Prospective randomized clinical trial | 130/98 | 100 mg rectal indomethacin versus inert placebo; before ERCP | Amylase level 3 times the upper limit of normal and epigastric pain or throughout the abdomen radiating to back associated with nausea or vomiting |
| Elmunzer et al. [4] | 2012 | American | Multicentre, randomized, placebo-controlled, double-blind clinical trial | 295/307 | 2 ∗ 50 mg rectal indomethacin versus placebo suppository; after ERCP | Amylase level 3 times the upper limit of normal and epigastric pain or throughout the abdomen radiating to back associated with nausea or vomiting |
| Döbrönte et al. [18] | 2014 | Hungary | Multicentre prospective, randomized, controlled trial | 347/318 | 100 mg, rectal indomethacin versus placebo suppository; before ERCP | Amylase level 3 times the upper limit of normal and epigastric pain or throughout the abdomen radiating to back associated with nausea or vomiting |
| Patai et al. [5] | 2015 | Hungary | Prospective, placebo-controlled, double-blind trial | 270/269 | 100 mg rectal indomethacin versus placebo suppository; before ERCP | Abdominal pain, extended hospitalization 2–3 days, elevation of amylase 3 times the upper limit of normal in 24 hours |
| Andrade-Dávila et al. [9] | 2015 | Mexico | Prospective randomized controlled trial | 82/84 | 100 mg rectal indomethacin versus glycerine; after ERCP | New or increased abdominal pain consistent with pancreatitis, elevated amylase or lipase greater than three times the normal upper limit until 24 hours after the procedure, and hospitalization (or prolongation of existing hospitalization) for at least 2 nights |
| Levenick et al. [8] | 2016 | America | Prospective, double-blind, placebo-controlledtrial | 223/226 | 100 mg rectal indomethacin versus placebo suppository; during the ERCP | New upper abdominal pain, an elevated lipase greater than three times the upper limit of the normal 24 hours after the onset of pain, and hospitalization for at least two nights |
| Hosseini et al. [20] | 2016 | Iran | Randomized controlled trial | 100/105 | 100 mg rectal indomethacin versus glycerine; before ERCP | New onset or worsened abdominal pain, increase in serum amylase at least 3 times above the upper limit of normal measured 24 h after the procedure, and need for more than one night of hospitalization |
| Luo et al. [11] | 2016 | China | Multicentre, single-blinded, randomized controlled trial | 1297/1303 | 100 mg rectal indomethacin versus no treatment; before ERCP | New onset of upper abdominal pain associated with an elevated serum amylase of at least three times the upper limit of normal range at 24 h after the procedure and admission to a hospital for at least 2 nights |
|
