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Prevention of Post-ERCP Pancreatitis by Indomethacin Vs Diclofenac

Rectal Disclofenac Versus Indomethacin for Prevention of Post-ERCP Pancreatitis (DIPPP): a Multicentre, Double-blind, Randomised, Controlled Trial

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05947461
Enrollment
1204
Registered
2023-07-17
Start date
2023-06-01
Completion date
2024-06-22
Last updated
2024-10-28

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

Conditions

Diclofenac, Endoscopic Retrograde Cholangiopancreatography, Indomethacin, NSAIDs, Post-ERCP Acute Pancreatitis

Brief summary

Post-ERCP pancreatitis (PEP) is the most common complication after ERCP, which was associated with occasional mortality, prolonged hospital days and increased health costs. Some studies investigated the effectiveness of different Nonsteroidal antiinflammatory drugs (NSAIDs) for prevent PEP. However, several high-quality RCTs and meta-analyses consistently demonstrated only100mg rectal indomethacin or diclofenac significantly reduced PEP incidence compared with placebos. Thus, European Society of Gastrointestinal Endoscopy, American Society for Gastrointestinal Endoscopy and Japanese Society of Hepato-Biliary-Pancreatic surgery guidelines recommended rountine administration of 100mg rectal indomethacin or diclofenac in unselected patients who underwent ERCP. Up to date, the mechanisms of NSAIDs in preventing pancreatitis were not fully elucidated. Diclofenac and Indomethacin showed similar inhibitory effects in phospholipase A2 and cyclooxygenase pathways. And the peak concentration of diclofenac and indomethacin both occurs between 30 and 90 min after rectal administration. However, diclofenac may be a stronger inhibitor of other pancreatitis-related imflammatory siginals (e.g. nuclear factor kappa-B) than indomethacin. Recently, several meta-analyses found 100mg rectal diclofenac to be more efficacious than 100mg rectal indomethacin. Despite these data, there is no conclusive evidence to prove that rectal diclofenac could provide incremental benefits over indomethacin from high-quality randomized, controlled trials. Therefore, the investigators conducted a multicenter, double-blind, randomized, controlled clinical trial to evaluate the efficacy of rectal diclofenac versus indomethacin for the prevention of post-ERCP pancreatitis in average-risk patients.

Interventions

DRUG100mg diclofenac

All patients without contraindications should receive 100mg rectal diclofenac 30mins before ERCP procedure

DRUG100mg indomethacin

All patients without contraindications should receive 100mg rectal indomethacin 30mins before ERCP procedure

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Participants in the interventional group received 100mg rectal dicfenac

Eligibility

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

Inclusion criteria

* 18-90 years old patients planned to undergo ERCP

Exclusion criteria

* Allergy to NSAIDs * The administration of NSAIDs within 7 days * Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction \[Cr \>1.4mg/dl=120umol/l\]; presence of coagulopathy before the procedure) * Previous biliary sphincterotomy and papillary large balloon dilation * Acute pancreatitis within 3 days before ERCP * Hemodynamical instability * Pregnancy or lactation * Unable to give informed consent

Design outcomes

Primary

MeasureTime frameDescription
Rate of post-ERCP Pancreatitis30 daysThe diagnosis of post-ERCP pancreatitis was confirmed if there was new onset of upper abdominal pain associated with an increased amylase or lipase level of at least 3 times the upper limit of normal range at 24 hours after ERCP, accompanied with extension of hospitalization for at least 2 nights.

Secondary

MeasureTime frameDescription
Rate of moderate or severe PEP30 daysThe severity classification of post-ERCP pancreatitis was defined according to the Cotton Criteria. Mild PEP: with an extension of hospitalization period of 2-3 days; Moderate PEP: with an extension of hospitalization period of 4-10 days; Severe PEP: with an extension of more than 10 days, or hemorrhagic pancreatitis, phlegmon, or pseudocyst, intervention (percutaneous drainage or surgery), or death.
Rate of Overall ERCP-related complications30 daysERCP-related complications include post-ERCP pancreatitis, gastrointestinal bleeding, perforation or infection according to Cotton Criteria.
Rate of patients with different severity of pancreatitis evaluated by revised Atlanta criteria30 days
Rate of NSAIDs-related complications30 daysNSAIDs-related complications include: acute kidney injury, allergic reaction, gastrointestinal bleeding, myocardial infarction, cerebrovascular accident, and death

Other

MeasureTime frameDescription
Rate of ERCP-related perforation30 daysPerforation was established according to Cotton criteria
Rate of ERCP-related infection30 daysInfection was established according to Cotton criteria
Rate of ERCP-related bleeding30 daysBleeding was established according to Cotton criteria
Rate of mortality30 days
Number of hospital days after ERCP180 days

Countries

China

Outcome results

None listed

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