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Efficacy and Safety of Emergency Pancreatic Duct Stenting to Prevent Severe Progression after Difficult ERCP Cannulation in Acute Biliary Pancreatitis: A Prospective, Multicenter, Stratified, Randomized Controlled Trial??

Efficacy and Safety of Emergency Pancreatic Duct Stenting to Prevent Severe Progression after Difficult ERCP Cannulation in Acute Biliary Pancreatitis: A Prospective, Multicenter, Stratified, Randomized Controlled Trial??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111624
Enrollment
Unknown
Registered
2025-11-03
Start date
2025-11-04
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

Acute Pancreatitis

Interventions

ERPD Group :Patients who successfully received pancreatic duct stent placement after undergoing emergency ERCP within 48 hours, following routine pre-procedure rectal indomethacin suppositories and ES
Non-ERPD Group :High-risk patients who underwent emergency ERCP within 48 hours of onset, routinely received pre-operative rectal indomethacin, underwent EST combined with ENBD/ERBD, and did not under

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old; 2. Meeting the diagnostic criteria for AP: According to the international consensus on the revision of the Atlanta Classification and Definitions in 2012, the diagnosis of AP requires two of the following three characteristics: Abdominal pain conforms to the features of acute pancreatitis (acute onset, persistent, severe upper abdominal pain often radiating to the back); The activity of serum lipase (or amylase) should be at least three times greater than the upper limit of normal. The characteristic changes of acute pancreatitis are detected by abdominal CT or less commonly used magnetic resonance imaging (MRI) or abdominal ultrasound. 3. Meet the diagnostic criteria for acute biliary pancreatitis: Imaging findings suggest the presence of bile sludge or gallstones, and common bile duct dilation (common bile duct diameter > 8mm in patients 10mm in patients over 75 years old). Or the concentration of alanine aminotransferase (ALT) is greater than twice the upper limit of normal; 4. Meet the diagnostic criteria for cholangitis: fever combined with common bile duct stones, common bile duct dilation or progressive cholestasis. Cholestasis is defined as serum bilirubin exceeding 2.3 mg/dL (40 µmol/L). 5. Within 48 hours of onset, emergency ERCP (EST+ENBD/ERBD) was performed and difficult intubation occurred during the operation: meeting the "5-5-2" criteria, that is, more than 5 attempts of intubation through the nipple, more than 5 minutes of intubation attempts under direct vision, and 2 or more accidental pancreatic intubation or imaging. 6. All patients who meet the inclusion and exclusion criteria must obtain their informed consent.

Exclusion criteria

Exclusion criteria: 1.Upon admission, the patient was diagnosed with necrotizing pancreatitis or infectious pancreatic necrosis. 2. Patients with severe multiple organ failure, coma, severe dementia or mental illness who cannot tolerate the operation; 3. Previous pancreatic cancer or other malignant tumors; 4. AP caused by other reasons; 5. Concurrent pregnancy; 6. Previous chronic renal insufficiency, heart failure and respiratory failure; 7. After gastrointestinal diversion surgery; 8. Postoperative pancreatic surgery; 9. During this hospitalization, percutaneous transhepatic biliary drainage (PTCD), cholecystostomy and cholecystectomy were performed.

Design outcomes

Primary

MeasureTime frame
The incidence rate of MSAP/SAP;

Secondary

MeasureTime frame
The incidence rate of APFC;The incidence rate of ARDS;

Countries

China

Contacts

Public ContactXiao Han

Shanghai General Hospital

hanxiao714@126.com+86 188 1782 1415

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026