Prophylaxis of Post-ERCP Acute Pancreatitis

PHASE3CompletedINTERVENTIONAL
Enrollment

184

Participants

Timeline

Start Date

May 13, 2022

Primary Completion Date

October 12, 2024

Study Completion Date

October 12, 2024

Conditions
Pancreatitis, Acute
Interventions
DRUG

Indomethacin suppository

Control Group: Patients will be randomized to receive a 100 mg indomethacin suppository will be administered immediately before the endoscopic procedure (20-30 minutes) and saline infusion will be given as needed.

COMBINATION_PRODUCT

Indomethacin suppository and high-flow lactated ringer infusion combination

Interventional group: Patients will be randomized to receive an indomethacin suppository that will be administered immediately before (20-30 minutes) the endoscopic procedure in combination with a lactated Ringer's infusion that will be administered with the following weight-based schedule: 3 cc/kg/h during ERCP, a bolus of 20 cc/kg after ERCP, and again 3 cc/kg/h for 8 hours after ERCP.

Trial Locations (10)

29121

Ospedale Guglielmo da Saliceto - AUSL Piacenza, Piacenza

40133

AUSL Bologna - Ospedale Maggiore Carlo Alberto Pizzardi, Bologna

41121

Azienda USL di Modena - Ospedale di Carpi, Carpi

41126

Azienda Ospedaliero-Universitaria di Modena - Ospedale civile di Baggiovara, Baggiovara

42122

AUSL- IRCCS di Reggio Emilia, Reggio Emilia

43100

Azienda Ospedaliero - Universitaria di Parma, Parma

44124

Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale sant'Anna, Ferrara

47121

AUSL della Romagna - Ospedale Morgagni-Pierantoni di Forlì, Forlì

47920

AUSL della Romagna - Ospedale Infermi di Rimini, Rimini

48100

AUSL Romagna - Ospedale Santa Maria delle Croci, Ravenna

All Listed Sponsors
lead

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV