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

Completed

• Conditions: Healthy
• Interventions: Device: Pancreatic duct stenting

• Registration Number: NCT04340687
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-07
• Last Update Submitted: 2020-04-07
• Study First Posted: 2020-04-09
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 664

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IP group	Pancreatic duct stenting	All patients recevied pancreatic duct stent during ERCP and one single dose of 100mg rectal indomethacin after ERCP.

Primary Outcome Measures

Name	Time	Method
Overall PEP	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 Outcome Measures

Name	Time	Method
Overall ERCP related complication	30 days

Trial Locations

Locations (1)

Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China