Combination of Rectal Indomethacin and Pancreatic Duct Stenting Versus Indomethacin Alone in Preventing Post-ERCP Pancreatitis in Patients With Difficult Cannulation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Air Force Military Medical University, China
- Enrollment
- 664
- Locations
- 1
- Primary Endpoint
- Overall PEP
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Investigators
Yanglin Pan
Associated professor
Air Force Military Medical University, China
Eligibility Criteria
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
Outcomes
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(30 days)