Obstructive jaundice
Conditions
Interventions
Experimental group:Endoscopic papillary balloon dilation (EPBD)
Control group:none
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: Adult patients aged 18 to 80 years. 2. Diagnosis: Patients with distal malignant biliary obstruction who are scheduled to undergo ERCP with biliary stent placement. 3. Laboratory criteria: Total bilirubin level >100 µmol/L, indicating significant cholestasis. 4. Informed consent: Patients who voluntarily participate in the study and have provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous history: Patients with a history of ERCP, prior sphincterotomy, or biliary stricture dilation. 2. Patients with acute pancreatitis or acute cholangitis/infection. 3. Significant comorbidities: such as severe cardiovascular disease, acute liver failure, etc. 4. Pregnant or lactating women. 5. Patients unable to comply with the study: those with language barriers, psychiatric disorders, or other conditions impairing their ability to understand and follow study requirements. 6. Patients with severe coagulopathy or those unable to tolerate dilation procedures. 7. Complete pancreatic duct obstruction or anomalies. 8. Benign biliary strictures. 9. Hilar biliary obstruction (strictures within 2 cm of the hepatic hilum).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of post-ERCP pancreatitis (PEP); | — |
Secondary
| Measure | Time frame |
|---|---|
| Complication rate within 30 days after ERCP;Difficulty in stent delivery system advancement;Serum total bilirubin level;Postoperative stent migration;Postoperative length of hospital stay; | — |
Countries
China
Contacts
Public ContactKangjie Chen
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed