Effect of rectal indomethacin and intravenous hydration in the prevention of pancreatitis after endoscopic retrograde cholangiopancreatography (single blind clinical trial)

Prophylactic effect of rectal indomethacin administration, with and without intravenous hydration, on the development of pancreatitis after retrograde cholangiopancreatography

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014082418915N1

Enrollment

406

Registered

2014-10-24

Start date

2013-05-12

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calculus of bile duct without cholangitis or cholecystitis. Choledocholithiasis

Interventions

Intervention 1: Placebo: Patients in the control group only receive rectal glycerin. Intervention 2: Intervention: Patients divide up into three study groups and receive the intervention 2 hours prior

Treatment - Drugs

Placebo: Patients in the control group only receive rectal glycerin.

Intervention: Patients divide up into three study groups and receive the intervention 2 hours prior to the procedure. The patients in the first group receive 100 mg of rectal indomethacin.

The patients in the second group receive intravenous normal saline perfusion.

The patients in the third group receive both interventions.

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age>18y; Patients are eligible if they are diagnosed with choledocolithiasis. Exclusion criteria: Patients with previous unsuccessful sphincterotomy; Decreased state of consciousness; Cardiovascular, renal diseases and under dialysis patients; Increased risk of bleeding; Evident acute pancreatitis, chronic pancreatitis or pancreatic cancer; Hyperamylasemia (= 150 IU/L); Allergy or hypersensitivity to indomethacin or water-soluble contrast solutions; Having ingested NSAIDs a week earlier are enrol

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Frequency of post endoscopic retrograde cholangiopancreatography pancreatitis. Timepoint: 2,12,24 hours post endoscopic retrograde cholangiopancreatography. Method of measurement: Clinical exam and serum amylase measurement.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMousalreza Hosseini

Mashad University Of Medical Sciences

Hoseinimr@mums.ac.ir+98 51 3801 2472

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026