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Modified Fully Covered Self-expandable Metal Stent vs. Plastic Stent for Preoperative Biliary Drainage in Patients with Resectable Malignant Biliary Obstruction

Modified Fully Covered Self-expandable Metal Stent vs. Plastic Stent for Preoperative Biliary Drainage in Patients with Resectable Malignant Biliary Obstruction - M-FCSEMS for preoperative biliary drainage

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030200
Enrollment
50
Registered
2018-12-31
Start date
2014-01-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Under IRB

Interventions

During August 2015 - August 2017 ERCP and biliary drainage with BONASTENT M-intraductal 12 or plastic stent performed. Re-intervention was performed for stent exchange or additional procedure when

Sponsors

SoonChunHyang University School of Medicine Digestive Disease Center and Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Age between 18 and 80 years -MBO at least 10 mm below the hilar bifurcation -Obstructive jaundice and/or cholangitis -No evidence of distant metastasis or major arterial invasion based on imaging studies

Exclusion criteria

Exclusion criteria: -MBO on hilum -Previous endoscopic biliary drainage or percutaneous transhepatic biliary drainage -Combined cholecystitis or pancreatitis -Surgically altered anatomy -Not underwent operation due to comorbidity, neoadjuvant chemotherapy, refusal or follow-up loss

Design outcomes

Primary

MeasureTime frame
PBD-related adverse events during the interval period up to surgery—

Secondary

MeasureTime frame
Re-intervention rate requiring additional procedure before surgery and Perioperative adverse events—

Countries

Asia(except Japan)

Contacts

Public ContactHyun Woo Lee

SoonChunHyang University School of Medicine Digestive Disease Center and Research Institute

imlhw@schmc.ac.kr+821080235271

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026