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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04340687
Enrollment
664
Registered
2020-04-09
Start date
2020-01-01
Completion date
2020-03-01
Last updated
2020-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Indomethacin, Double-guidewire technique, Adverse events, PEP, PD stenting

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).

Interventions

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

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall PEP30 daysPEP 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

MeasureTime frame
Overall ERCP related complication30 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026