A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent

Malignant Biliary Obstruction Clinical Trial

Official title:

A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent: Prospective Randomized Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05220475
• Other study ID #: H-2012-043-1179
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: October 24, 2024

Study information

• Verified date: January 2022
• Source: Seoul National University Hospital
• Contact: Sang Hyub Lee, MD, PhD
• Phone: 82-2072-2228
• Email: gidoctor[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multi-center, randomized controlled study fc-SEMS with anchoring plastic stent vs uc-SEMS in malignant biliary obstruction

Description:

This study is multi-center, randomized controlled study to compare the stent patency in malignant biliary obstruction. The patency of fully covered self expandable metal stent with external anchoring plastic stent was compared with that of uncovered self expandable metal stent.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: October 24, 2024
• Est. primary completion date: October 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Adults with 19 years of age or older

• Those who voluntarily consented to the trial and signed a written consent

• Inoperable malignant biliary obstruction

Exclusion Criteria:

• Previous surgical biliary drainage

• Patients continuosly requiring percutaneous transhepatic biliary drainage

• History of biliary drainage with metal stent

• Biliary obstruction located in hilum or intrahepatic duct

• Patients with life expectancy of 3 months or less

• On pregnancy

• Unable to underwent endoscopic procedures

Related Conditions & MeSH terms

• Malignant Biliary Obstruction

Intervention

Device:
• fully covered self-expandable metal stent with an anchoring external plastic stent
Extrahepatic malignant biliary obstruction treated with fully covered self-expandable metal stent with an anchoring plastic stent
• uncovered self-expandable metal stent
Extrahepatic malignant biliary obstruction treated with uncovered self-expandable metal stent without an anchoring plastic stent

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patent stent	The number of patient without stent dysfuction divided by total number of patients	1 year
Secondary	Stent obstruction	Suspected by jaundice (Total bilirubin > 2 upper normal limit) or radiologic finding of stent occlusion which is confirmed by ERCP	1 year
Secondary	Stent migration	Radiologic finding of migration through Abdomen X-ray or CT scan	1 year
Secondary	Re-intervention	Endoscopic retrograde biliary drainage or Percutaneous transhepatic biliary drainage	1 year
Secondary	Adverse event	acute cholangitis, acute cholecystitis, acute pancreatitis	1 year
Secondary	Overall survival	Timespan from the diagnosis to the death	1 year