Comparison between transpapillary and suprapapillary metal stent

Comparison between transpapillary and suprapapillary metal stent placement with endoscopic sphincterotomy in common bile duct malignant obstruction: prospective randomized controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005624

Enrollment

156

Registered

2020-11-24

Start date

2020-12-01

Completion date

Unknown

Last updated

2020-12-02

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

Conditions

None listed

Interventions

Procedure/Surgery : The lower end of the metal stent can be located in two main locations, either in the common bile duct above the major ampulla (group 1) or in the duodenum through the major ampulla

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • patients with common bile duct obstruction due to malignancy

Exclusion criteria

Exclusion criteria: • intrahepatic or perihilar bile duct obstruction (except Klatskin type I) • patients who have operability or want surgery • strictures located within 2 cm from the end of distal common bile duct • patients who are not able to undergo endoscopy due to cardiovascular or pulmonary diseases • patients whose informed consents are not received • patients in whom an endoscope can not access to the ampulla due to anatomical deformity by previous surgery

Design outcomes

Primary

Measure	Time frame
stent patency or jaundice-free survival	—

Secondary

Measure	Time frame
in-stent stenosis or tumor overgrowth;stone or sludge occurrence;overall survival;acute cholangitis occurrence;stent migration rate	—

Countries

Korea, Republic of

Contacts

Public ContactJae Hyuck Chang

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

Outcome results