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

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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Key information

Conditions

Healthy

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients underwent diagnostic or therapeutic ERCP
With native papilla
With difficult cannulation (cannulation time >10min or cannulation attempts >5 times or inadvertently PD cannulation ≥1)
Receiving post-ERCP rectal indomethacin

Exclusion criteria

Patients with indications of PD cannulation
No attempt of cannulation due to inaccessible papilla
Non-difficult cannulation

Treatment and study plan

Pancreatic duct stenting

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

Primary outcomes

Overall PEP

Time frame: 30 days

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.

Secondary outcomes

Overall ERCP related complication

Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

Combination of Rectal Indomethacin and Pancreatic Duct Stenting Versus Indomethacin Alone in Preventing Post-ERCP Pancreatitis in Patients With Difficult Cannulation

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Apr 9, 2020
Registry last updated: Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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