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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,278
All patients without contraindications should receive 100mg rectal indomethacin or diclofenac within 30mins before ERCP procedure
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.
The first medical center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGDepartment of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGDepartment of Gastroenterology, Fujian Medical University Xiamen Humanity Hospital
Xiamen, Fujian, China
RECRUITINGHarbin Medical University Affiliated Fourth Hospital
Harbin, Heilongjiang, China
RECRUITINGThe Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGDepartment of Gastroenterology, Huaihe Hospital of Henan University
Kaifeng, Henan, China
RECRUITINGTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGThe Third Xiangya Hospital of Central South University
Changsha, Hunan, China
NOT_YET_RECRUITING986 Hospital of Xijing Hospital
Xi'an, Shaanxi, China
RECRUITINGXijing of Digestive Diseases
Xi'an, Shaanxi, China
RECRUITING...and 5 more locations
Rate of post-ERCP Pancreatitis
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
Time frame: 30 days
Rate of mild, moderate or severe PEP
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.
Time frame: 30 days
Rate of patients with different severity of pancreatitis evaluated by revised Atlanta criteria
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).
Time frame: 30 days
Rate of ERCP-related perforation
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.
Time frame: 30 days
Rate of ERCP-related infection
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.
Time frame: 30 days
Rate of ERCP-related bleeding
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.
Time frame: 30 days
The rate of total adverse events
Adverse events include ERCP-related or non ERCP-related adverse events
Time frame: 30 days
The rate of successful pancreatic duct stent placements
Time frame: 1 day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.