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This is a prospective study to evaluate the effectiveness and safety of a newly developed domestically produced biliary plastic stent compared to a foreign-made biliary plastic stent in patients with biliary stenosis.

Comparative evaluation of safety and effectiveness between the newly developed domestically produced biliary plastic stent (OptimosTM Plastic stent) and existing foreign plastic biliary tract stents

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009770
Enrollment
250
Registered
2024-09-06
Start date
2024-05-14
Completion date
Unknown
Last updated
2024-11-14

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

Conditions

None listed

Interventions

None listed

Sponsors

Yonsei University Health System, Gangnam Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1). Adult patients over 20 years of age with confirmed biliary stricture on radiology or endoscopic angiography 2). Patients with or suspected to have biliary tract disease 3). Patients who require endoscopic retrograde pancreatography for treatment 4). Patients requiring stent insertion for biliary drainage

Exclusion criteria

Exclusion criteria: 1). under 20 years old 2). pregnant patient 3). retarded patient 4). Patients hypersensitive to contrast media 5). Patients with papillary tumors 6). Patients who underwent hepatobiliary surgery 7). Patients in whom endoscopic access to the papilla is difficult due to abdominal surgery (total gastrectomy, subtotal gastrectomy, etc.)

Design outcomes

Primary

MeasureTime frame
Mean patency duration

Secondary

MeasureTime frame
1) technical & clinical success rates 2) stent spontaneous migration rate 3) perforation 4) bleeding 5) cholangitis

Countries

Korea, Republic of

Contacts

Public ContactSung Ill Jang

Yonsei University Health System, Gangnam Severance Hospital

aerojsi88@gmail.com+82-2-2019-3580

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026