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Assessment of the effect of sublingual isosorbide dinitrate with indomethacin suppository on post Endoscopic retrograde colangiopancreatography pancreatitis

Evaluation of the effect of sublingual isosorbide dinitrate + indomethacin suppository in prevention of post Endoscopic retrograde colangiopancreatography (ERCP) pancreatitis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT138810082931N1
Enrollment
300
Registered
2012-11-19
Start date
2011-02-20
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

pancreatitis. Idiopathic acute pancreatitis

Interventions

Intervention 1: indomethacin 100 mg anal with sublingual tablet of isosorbide dinitrate 5 mg. Intervention 2: indomethacin 100 mg anal with sublingual placebo of isosorbide dinitrate 5 mg.
Treatment - Drugs
Placebo
indomethacin 100 mg anal with sublingual tablet of isosorbide dinitrate 5 mg
indomethacin 100 mg anal with sublingual placebo of isosorbide dinitrate 5 mg

Sponsors

Digestive disease research center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Study populations are all patients referred to Shariati hospital who undergo therapeutic or diagnostic ERCP in endoscopy ward. Exclusion criteria: age<18; HX of nitrate use; HX of recent acute pancreatitis (less than one month); HX of chronic pancreatitis; recent (2weeks) peptic ulcer bleeding; HX of glaucoma; ampullary tumor; use of sildenafil; unwilling for consent; allergy to drugs; previous sphincterotomy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Post ercp pancratitis. Timepoint: 24 hours after ercp. Method of measurement: pain observative scale, serum amylase measurement, hospitalation period.

Secondary

MeasureTime frame
Nausea and vomiting. Timepoint: 24 hours after procedure. Method of measurement: asking from patient.;Fever/chills. Timepoint: 2 and 24 hours after procedure. Method of measurement: check of fever grade with termometer.;Upper GI bleeding. Timepoint: 2 and 24 hours after procedure. Method of measurement: check of vital sighns, hematemesis and melena.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Farsinejad

Digestive Disease Research Center

maryfnm@yahoo.com+98 21 8241 5770

Outcome results

None listed

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