Comparative Study of Metal and Plastic Stents for Preoperative Biliary Drainage in Patients with Pancreatic Cancer

8-mm diameter modified fully covered self-expandable metal stent versus plastic stent for preoperative biliary drainage in resectable and borderline resectable pancreatic cancer: A prospective multicenter randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0012188

Enrollment

Registered

2026-06-29

Start date

2026-07-06

Completion date

Unknown

Last updated

2026-07-13

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 : Patients will be randomly assigned in a 1:1 ratio to either the M-FCSEMS group or the PS group. Randomization will be performed using a computer-generated sequence created with Stata

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients aged 19–80 years ? Patients with resectable or borderline resectable pancreatic cancer presenting with a biliary stricture located at least 2 cm distal to the hepatic hilum ? Total bilirubin > 3.5 mg/dL ? No evidence of major arterial invasion or distant metastasis on imaging studies.

Exclusion criteria

Exclusion criteria: ? Hilar malignant biliary obstruction ? Patients who have previously undergone endoscopic or percutaneous biliary drainage ? Patients with concomitant cholecystitis or pancreatitis ? Patients with surgically altered anatomy ? Patients who are scheduled to receive neoadjuvant chemotherapy or are considered unfit for surgery due to comorbidities or other reasons

Design outcomes

Primary

Measure	Time frame
Re-intervention rate	—

Secondary

Measure	Time frame
Technical success;Adverse events	—

Countries

Korea, Republic of

Contacts

Public ContactIl Sang Shin

Soon Chun Hyang University Hospital Bucheon

ilsang.shin@schmc.ac.kr+82-32-621-5094

Outcome results