Combination of Rectal Indomethacin and Pancreatic Duct Stenting Versus Indomethacin Alone in Preventing PEP

Air Force Military Medical University, China664 enrolled

Overview

Rectal indomethacin and pancreatic duct (PD) stenting (PDS) are recommended for the prevention of post-ERCP pancreatitis (PEP). However, the effects of the combination of the two methods on preventing PEP are controversial. We hypothesized that some group of patients with difficult cannulation might benefit from the combination of indomethacin plus PDS (IP) compared with indomethacin alone (IN).

Study Type

OBSERVATIONAL

Enrollment

664

Conditions

Healthy

Interventions

Pancreatic duct stentingDEVICE

A stent placed in the pancreatic duct to reduce PEP possibly by relieving pancreatic ductal hypertension that develops because of transient procedure-induced edema and stenosis of the pancreatic orifice

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients underwent diagnostic or therapeutic ERCP 2. With native papilla 3. With difficult cannulation (cannulation time \>10min or cannulation attempts \>5 times or inadvertently PD cannulation ≥1) 4. Receiving post-ERCP rectal indomethacin Exclusion Criteria: 1. Patients with indications of PD cannulation 2. No attempt of cannulation due to inaccessible papilla 3. Non-difficult cannulation

Locations (1)

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Outcomes

Primary Outcomes

Overall PEP

PEP was diagnosed if there was a worsening or new onset of pain in the upper abdomen, an elevation in serum amylase of at least three times of the upper limit of the normal range 24h after the procedure and requiring at least two nights of hospitalization.

Time frame: 30 days

Secondary Outcomes

Overall ERCP related complication

Time frame: 30 days

Data from ClinicalTrials.gov

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