A multicenter, randomized, controlled trial to reveal the efficacy of fully covered vs uncovered SEMS for malignant biliary obstruction caused by unresectable pancreatic cancer (confirmatory Trial)

A multicenter, randomized, controlled trial to reveal the efficacy of low axial force designed Dumbbell head shaped SEMS (self-expandable metallic stent) for malignant biliary obstruction caused by unresectable pancreatic cancer (fully covered vs. uncovered)(confirmatory trial) - LPAC Study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs052210032

Enrollment

300

Registered

2021-06-02

Start date

2021-07-05

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

malignant biliary obstruction caused by unresectable pancreatic cancer malignant biliary obstruction, unresectable pancreatic cancer

Interventions

FCMCS: groups who are used fully covered HILZO stents for malignant biliary obstruction caused by unresectable pancreatic cancer UCMS: groups who are used uncovered HILZO stents for malignant biliary

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Unresectable pancreatic cancer (UR-LA,UR-M) causing distal biliary obstruction (2)Pathologically confirmed diagnosis or patients with suspected pancreatic cancer who are scheduled to undergo a pathological examination(It does not matter whether it is by cytology or histology) (3)Patients aged 20 and over who have given sufficient explanation about the content of the study and have proved informed consent created by the patient's will based on the understanding of the content. (In principle, cancer notification shall be given.)

Exclusion criteria

Exclusion criteria: (1)Cases with Performance status of 4 (2)Cases with serious complications in other organs.such as ASA classification 3 or higher (Subject who is dialysis also excluded) (3)Cases with hilar biliary obstruction (4)Cases with bordeline resectable pancreatic cancer (BR), hilar biliary obstruction associated with lymphadenopathy (5)Cases where informed consent cannot be obtained (6)Cases with Uncontrollable cholangitis (7)Cases with an expected prognosis of less than 3 months (8)Cases where the condition worsens after the first biliary drainage (9)Cases judged by the investigator (in-charge doctor) to be inappropriate as a subject

Design outcomes

Primary

Measure	Time frame
Duration of stent patency	—

Secondary

Measure	Time frame
(1) procedure succss rate, (2) clinical success rate, (3) re-intervention success rate, (4) reason of stent occlusion, (5) survival period, (6) adverse event rate, (7) chemotherapy after biliary drainage	—

Contacts

Public ContactMamoru Takenaka

Kindai University Hospital

mamoxyo45@gmail.com+81-72-288-7222

Outcome results

None listed

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