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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

664 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-03-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IP group

All patients recevied pancreatic duct stent during ERCP and one single dose of 100mg rectal indomethacin after ERCP.

Pancreatic duct stenting

Intervention Type DEVICE

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

IN group

All patients received one single dose of 100mg rectal indomethacin after ERCP.

No interventions assigned to this group

Interventions

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Pancreatic duct stenting

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

Intervention Type DEVICE

Eligibility Criteria

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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