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Efficacy of uncovered double bare metal stent compared to covered metal stent in malignant biliary obstruction: A multicenter randomized trial

Efficacy of uncovered double bare metal stent compared to covered metal stent in malignant biliary obstruction: A multicenter prospective randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008265
Enrollment
236
Registered
2023-03-07
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-05-30

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

Conditions

None listed

Interventions

Medical Device : Insertion of metal stent (single metal stent with a cover and a double metal stent without a cover.) for malignant biliary tract obstruction through ERCP, The stent patency was compar

Sponsors

Yonsei University Health System, Gangnam Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A patient whose malignant tumor invading the biliary tract was confirmed histologically or radiographically, or who had clinical obstruction symptoms and radiographic findings related to malignant tumor-related biliary obstruction and proximal bile duct dilatation. (the range of lesions is for pancreatic cancer, biliary tract cancer, gallbladder cancer, papillary cancer, liver cancer, gastrointestinal cancer that can cause biliary tract obstruction, and metastatic lymph nodes)

Exclusion criteria

Exclusion criteria: 1. Resectable bile duct cancer 2. Malignant hilar biliary obstruction 3. Duodenal obstruction 4. Patients with other malignancies other than malignant tumors that invaded the biliary tract 5. Patients with uncontrolled serious infection 6. Patients who failed to obtain informed consent from the patient 7. Patients who are technically unable to perform endoscopic procedures

Design outcomes

Primary

MeasureTime frame
Mean patency duration

Secondary

MeasureTime frame
6-months patency rate

Countries

Korea, Republic of

Contacts

Public ContactSung Yong Han

Pusan National University Hospital

mirsaint@hanmail.net+82-51-240-7869

Outcome results

None listed

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