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NCT Number: NCT07117318

Rectal NSAIDs With/Without PD Stent for PEP Prevention

Pancreatitis is the most common and serious complication following post-endoscopic retrograde cholangiopancreatography (ERCP) and is associated with occasional mortality, extended hospital stays, and increased healthcare expenses. Rectal non-steroidal anti-inflammatory drugs (NSAIDs) and pancreatic duct stent (PDS) placement were demonstrated to be effective strategyies to reduce PEP incidences, particlularly in high-risk patients for post-ERCP pancreatitis (PEP).

Rectal NSAIDs were easy-to-use and safe, while PDS placement were technically complex and carried higher risks of adverse events. A previous network meta-analysis suggested rectal NSAIDs in combination with PDS placement did not differ from rectal NSAIDs alone in PEP prevention. To invesigate if rectal NSAIDs alone could obivate the need of PDS placement, a recent trial from Elmunzer et al. conducted a randomized trial to investigate if rectal NSAIDs alone was non-inferior to the combination of NSAIDs with PDS in high-risk patients. The trial found that the PEP incidence rate in combination group was significantly lower than that in NSAIDs alone group. However, post-hoc analysis of the study suggested that the combination strategy conferred significant benefits only in high-risk patients with pancreatic duct (PD) wire passage, but not in those with other risk factors. Therefore, we hypothesized that rectal NSAIDs alone may obivate the need of PDS in high-risk patients without PD wire passages. Here, we conducted a multicenter, randomized and non-inferiority trial to investigate whether rectal NSAIDs alone is non-inferior to NSAIDs plus PDS placement in high-risk patients without PD wire passages.

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Key information

Conditions

Post-ERCP Acute Pancreatitis Non-steroid Anti-inflammatory Drugs Pancreatic Duct Stent Placement

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The first medical center, Chinese PLA General Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-90 years old patients with native papilla who planned to undergo ERCP
  • high-risk patients for post-ERCP pancreatitis must meet one or more following criteria: clinical suspicion of sphincter of Oddi dysfunction, a history of PEP, pancreatic sphincterotomy, precut sphincterotomy, difficult cannulation (>5 cannulation attempts, or >5mins cannulation time, or >1 unintentional pancreatic duct cannulation), or ballon dilatation of an intact biliary sphincter ≤ 1 min, double-wire cannulation. Additionally, patients were considered high-risk if they fulfilled two or more of the following minor criteria: female gender under 50 years old, a history of recurrent pancreatitis (two or more episodes), three or more contrast injections into the pancreatic duct with at least one injection reaching the tail of the pancreas, opacification of pancreatic acini, or brush cytology performed on the pancreatic duct.

Exclusion criteria

  • Previous biliary sphincterotomy and papillary large balloon dilation
  • Planned for placements of pancreatic duct stents (eg. pancreatic duct strictures, planned ampullectomy)
  • 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)
  • Acute pancreatitis within 7 days before ERCP or acute pancreatitis with obvious Pancreatic edema and peripancreatic fluid collections
  • Hemodynamical instability
  • Pregnancy or lactation
  • high-risk patients with pancreatic duct wire passages

Treatment and study plan

NSAIDs

Drug

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

NSAIDs plus PDS

Device

All patients without contraindications should receive 100mg rectal indomethacin or diclofenac within 30mins before ERCP procedure. When eligibility is met, PDS placement will be performed by ERCP colonoscopists.

Primary outcomes

  1. Rate of post-ERCP Pancreatitis

    Time frame: 30 days

    a new or aggravated upper abdominal pain, with an elevated pancreatic enzyme of at least 3 times as the upper limit of normal value 24h after procedure and prolonged hospitalization days for at least 2 days. This definition was based on a widely recognized Cotton consensus

Secondary outcomes

  1. Rate of mild, moderate or severe PEP

    Time frame: 30 days

    The 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.

  2. Rate of patients with different severity of pancreatitis evaluated by revised Atlanta criteria

    Time frame: 30 days

    Mild: The most common form of acute pancreatitis, without organ failure or local or systemic complications, generally resolving within 1 week of onset. Moderately Severe: the presence of transient organ failure, local complications or exacerbation of co-morbid disease.

    Severe: persistent organ failure, that is, organ failure >48 h. Local complications are peripancreatic fluid collections, pancreatic and peripancreatic necrosis (sterile or infected), pseudocyst and walled-off necrosis (sterile or infected).

  3. Rate of ERCP-related perforation

    Time frame: 30 days

    Perforation was established according to Cotton criteria, Mild: slight leakage of fluid or contrast dye, manageable through fluid administration and suction therapy ≤3 days Moderate: definite perforation required to be managed for 4-10 days Severe: management for more than 10 days or requiring for percutaneous or surgical intervention.

  4. Rate of ERCP-related infection

    Time frame: 30 days

    Infection was established according to Cotton criteria. Mild: temperature >38# for 24-48h Moderate: Febrile illness requiring >3 days of hospital treatment; endoscopic or percutaneous interventions; Severe: septic shock or requiring surgery.

  5. Rate of ERCP-related bleeding

    Time frame: 30 days

    Bleeding was established according to Cotton criteria. Mild: a documented decrease in hemoglobin concentration by <3 g/L, without requiring the blood transfusion; Moderate: blood transfusion ≤4 units; without need for angiographic or surgery interventions Severe: Transfusion: ≥5 units or requiring for angiographic or surgery interventions.

  6. The rate of total adverse events

    Time frame: 30 days

    Adverse events include ERCP-related or non ERCP-related adverse events

  7. The rate of successful pancreatic duct stent placements

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

Rectal Non-steroid Anti-inflammatory Drugs With or Without Prophylactic Pancreatic Duct Stent for Prevention of Post-ERCP Pancreatitis: a Multicenter, Randomized, Non-inferiority Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Aug 12, 2025
Registry last updated
Dec 3, 2025

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

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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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