Effectiveness of a Newly Developed Antireflux Metal Stent in Patients with Unresectasble Distal Malignant Biliary Obstruction

Effectiveness of a Newly Developed Antireflux Metal Stent in Patients with Unresectasble Distal Malignant Biliary Obstruction: A Multi-center Randomized Prospective Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0008006

Enrollment

150

Registered

2022-12-13

Start date

2023-01-02

Completion date

Unknown

Last updated

2023-01-10

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 : Randomization is performed in both groups using computer generated numbers. If the patient complies with the selection criteria and agrees to the study, pre-randomization is performe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Older than 18 years of age 2.Malignant biliary obstruction revealed by CT and/or magnetic resonance imaging, 3.Obstructive jaundice 4.Malignant biliary obstruction proximal margin 2cm or more from the hepatic hilum 5 Not a candidate for curative surgical resection due to tumor stage or operative risks

Exclusion criteria

Exclusion criteria: 1. Previously insertion of biliary metal stent 2. Decompensated cardiopulmonary disorders 3. Uncontrolled coagulation disorders 4. Pregnancy 5. Altered anatomical structure due to surgery 6. Active hepatitis or other hepatic diseases that may cause jaundice 7. Inability to provide informed consent

Design outcomes

Primary

Measure	Time frame
Stent patency	—

Secondary

Measure	Time frame
Technical success rate	—

Countries

Korea, Republic of

Contacts

Public ContactSUNG WOO KO

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

gogo930@catholic.ac.kr+82-2-2030-4595

Outcome results