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The application of "double stent" placement of bile duct combined with pancreatic duct versus "single stent" placement of bile duct in improving pain in pancreatic cancer patients with obstructive jaundice and pancreatic duct dilatation: a prospective, randomized controlled study

The application of "double stent" placement of bile duct combined with pancreatic duct versus "single stent" placement of bile duct in improving pain in pancreatic cancer patients with obstructive jaundice and pancreatic duct dilatation: a prospective, randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101257
Enrollment
Unknown
Registered
2025-04-22
Start date
2025-04-22
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Pancreatic cancer

Interventions

Intervention group:"Double stent" placement of bile duct combined with pancreatic duct
Control group:"Single stent" placement of bile duct

Sponsors

Department of Gastroenterology, The First Affiliated Hospital of Naval Medical University(( shanghai changhai hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Pancreatic cancer patients who are not candidates for surgical resection; 2.Presence of obstructive jaundice; 3.Pancreatic duct dilation confirmed by imaging examinations (e.g., ultrasound, CT, MRI, or endoscopic ultrasound); 4.Pancreatic cancer-related upper abdominal or back pain with a Numerical Rating Scale (NRS) score >=4; 5.No prior radiotherapy or chemotherapy before enrollment; 6.Age >=18 years.

Exclusion criteria

Exclusion criteria: 1.Patients with suspected concurrent malignancies in other sites; 2.Patients with altered gastrointestinal anatomy due to previous pancreatic or abdominal surgery; 3.Concurrent enrollment in other drug or therapeutic trials within 30 days prior to study initiation; 4.Expected survival <3 months; 5.Pain with a definitive non-cancer etiology (e.g., peptic ulcer disease, rheumatoid arthritis); 6.Contraindications to ERCP (e.g., uncorrectable coagulopathy, cardiopulmonary insufficiency); 7.Prior receipt of pain management interventions (e.g., celiac plexus neurolysis (CPN), intrathecal/epidural analgesia, or radioactive iodine seed implantation); 8.Patients with psychiatric disorders or inability to cooperate with pain/quality of life assessments; 9.Patients refusing study participation or declining informed consent; 10.Any other factors deemed by investigators to compromise study eligibility or participation.

Design outcomes

Primary

MeasureTime frame
Effective rate of pain relief;

Secondary

MeasureTime frame
Doses of opioid analgesics ;Mini Nutritional Assessment (MNA) score;Quality of Life Score (EORTC QLQ-C30);Incidence of post-ERCP adverse events;Effective duration of pain relief;Changes in liver function;Success rate of stent placement;Changes in amylase ;

Countries

China

Contacts

Public ContactLei Wang

Department of Gastroenterology, The First Affiliated Hospital of Naval Medical University(shanghai changhai hospital)

onerain@126.com+86 139 1805 6052

Outcome results

None listed

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