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12-mm Partial Covered Versus Bare Self-Expandable Metallic Stents for Malignant Distal Biliary Obstruction

ConditionsMalignant Distal Biliary ObstructionMalignant Biliary ObstructionBiliary Obstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorChung-Ang University Hospital

About this trial

Metallic stents are commonly used for biliary drainage in patients with unresectable malignant distal biliary obstruction. However, it is unclear whether a 12-mm partially covered self-expandable metallic stent or a 12-mm bare self-expandable metallic stent provides better effectiveness and safety. This prospective, randomized clinical trial will compare these two stent types in adult patients who have already undergone percutaneous transhepatic biliary drainage (PTBD) and are scheduled for metallic stent placement through the existing PTBD tract. A total of 60 participants will be enrolled. After stent placement, participants will be followed for 12 months, with assessments at 3, 6, and 12 months. The study will evaluate recurrent biliary obstruction, stent patency duration, reintervention, overall survival, and procedure-related complications. The results are expected to provide evidence for selecting the most appropriate 12-mm metallic stent for patients with unresectable malignant distal biliary obstruction.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who voluntarily provide written informed consent after receiving sufficient explanation of the study purpose, methods, and potential benefits and risks

Adults aged 19 years or older

Patients diagnosed with unresectable malignant distal biliary obstruction based on imaging studies (CT, MRI, ERCP, etc.) or histologic confirmation

Patients who have already undergone percutaneous transhepatic biliary drainage (PTBD) according to the institutional clinical protocol and are scheduled for metallic stent placement through the existing PTBD tract

Disqualifiers

Patients with a previous history of biliary metallic stent placement

Patients with upper biliary obstruction (hilar level or above)

Patients with other major biliary lesions in addition to malignant distal biliary obstruction

Patients for whom the investigator judges that study conduct or data collection would be markedly difficult

Trial design

Design model

Parallel

Treatments tested in this trial

  • 12-mm partially covered self-expandable metallic stent

    Device

    A 12-mm partially covered self-expandable metallic stent placed through the existing percutaneous transhepatic biliary drainage (PTBD) tract for internal biliary drainage in patients with unresectable malignant distal biliary obstruction.

  • 12-mm bare self-expandable metallic stent

    Device

    A 12-mm bare self-expandable metallic stent placed through the existing percutaneous transhepatic biliary drainage (PTBD) tract for internal biliary drainage in patients with unresectable malignant distal biliary obstruction.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: 12-mm Partially Covered SEMS GroupExperimental treatment 1 intervention
Group B: 12-mm Bare SEMS GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative incidence of recurrent biliary obstruction (RBO) within 12 months after the procedure

Cumulative incidence of recurrent biliary obstruction related to the initially inserted study stent (index stent).

Time frame
12 months after the procedure

Secondary outcomes

1

Time to recurrent biliary obstruction (Time to RBO; stent patency duration)

Time from the procedure to recurrent biliary obstruction of the initially inserted study stent (index stent); stent patency duration.

Time frame
Up to 12 months after the procedure
2

Overall rate of recurrent biliary obstruction (RBO)

Overall rate of recurrent biliary obstruction during follow-up.

Time frame
Up to 12 months after the procedure
3

Number of participants by cause of recurrent biliary obstruction

Number of participants with recurrent biliary obstruction classified by cause, including tumor ingrowth, tumor overgrowth, sludge, and stent migration.

Time frame
Up to 12 months after the procedure
4

Rate of reintervention

Rate of participants requiring reintervention, including additional metallic stent p

Time frame
Up to 12 months after the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chung-Ang University Hospital

Lead sponsor

OSYMED CO., Ltd.

Collaborator

Source ClinicalTrials.gov
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