Clinical trial NCT05947461: Prevention of Post-ERCP Pancreatitis by Indomethacin Vs Diclofenac
Official title: Rectal Disclofenac Versus Indomethacin for Prevention of Post-ERCP Pancreatitis (DIPPP): a Multicentre, Double-blind, Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-ERCP Acute Pancreatitis
NSAIDs
Indomethacin
Diclofenac
Endoscopic Retrograde Cholangiopancreatography
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 1204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants in the interventional group received 100mg rectal dicfenac
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of post-ERCP Pancreatitis
timeFrame: 30 days
Secondary outcomes:
measure: Rate of moderate or severe PEP
timeFrame: 30 days
measure: Rate of Overall ERCP-related complications
timeFrame: 30 days
measure: Rate of patients with different severity of pancreatitis evaluated by revised Atlanta criteria
timeFrame: 30 days
measure: Rate of NSAIDs-related complications
timeFrame: 30 days
Other outcomes:
measure: Rate of ERCP-related perforation
timeFrame: 30 days
measure: Rate of ERCP-related infection
timeFrame: 30 days
measure: Rate of ERCP-related bleeding
timeFrame: 30 days
measure: Rate of mortality
timeFrame: 30 days
measure: Number of hospital days after ERCP
timeFrame: 180 days
Locations:
city: Chongqing
country: China
facility: Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Xiamen
country: China
facility: Department of Gastroenterology, Fujian Medical University Xiamen Humanity Hospital
state: Fujian
city: Shijia Zhuang
country: China
facility: Department of Gastroenterology, The 980th Hospital of the PLA Joint Logistics Support Force
state: Hebei
city: Kaifeng
country: China
facility: Department of Gastroenterology, Huaihe Hospital of Henan University
state: Henan
city: Yinchuan
country: China
facility: Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University
state: Ningxia
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Department of Gastroenterology,The 986th Hospital of Xijing Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases, Air Force Military Medical University, China
state: Shaanxi
city: Xi'an
country: China
facility: Deparment of hepatobiliary surgery, The First Affiliated Hospital Of Xi'an Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: Department of Gastroenterology and Endoscopy, Department of Gastroenterology and EndoscopyThe Third Affiliated Hospital of Naval Military Medical University
state: Shanghai
city: Urumqi
country: China
facility: Department of Gastroenterology, General Hospital of Xinjiang Military Region
state: Xinjiang
Study officials:
References:
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