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Octreotide and indomethacin in the prevention of post ERCP pancreatitis

Investigating the effect of adding octreotide to indomethacin compared to indomethacin alone in preventing pancreatitis after ERCP in high-risk patients: a randomized clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240302061146N1
Enrollment
88
Registered
2024-04-05
Start date
2024-04-20
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Acute pancreatitis following endoscopic retrograde cholangiopancreatography. Acute pancreatitis, unspecified

Interventions

Intervention 1: Intervention group (Indomethacin + octreotide group): Octreotide will be infused 100 micrograms intravenously during ERCP as a state and then 50 micrograms intravenously every six hour

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Participants aged between 18 and 75 years Participants with normal levels of amylase and lipase before undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP). Presence of high-risk criteria for post-ERCP pancreatitis based on UpToDate recommendations Multiple cannulations during ERCP History of previous pancreatitis following ERCP Dysfunction of type one and two sphincter of Oddi Repeated injection of contrast material or other fluids into the main pancreatic duct Balloon dilation of an intact biliary sphincter Pancreatic sphincterotomy.

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Known hypersensitivity to somatostatin Liver or kidney failure Referral with manifestations of an episode of acute pancreatitis or chronic pancreatitis Use of antibiotics, antacids, and other medications that may interfere with the effects of somatostatin History of previous angina, myocardial infarction, or cerebral ischemia within the past three months

Design outcomes

Primary

MeasureTime frame
Occurrence of post-ERCP pancreatitis. Timepoint: After 5 hours, and after 10 hours following ERCP. Method of measurement: Obtaining a medical history in terms of abdominal pain along with measuring serum levels of amylase and lipase.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoham Gholami

Mashhad University of Medical Sciences

dr_rgholami@yahoo.com+98 51 3854 3031

Outcome results

None listed

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