Utility of side-by-side and simultaneous bilateral placement of metal stent for hilar biliary obstruction

Utility of side-by-side and simultaneous bilateral placement of metal stent for malignant hilar biliary obstruction: A multicenter prospective single-arm feasibility study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003617

Enrollment

Registered

2019-03-13

Start date

2019-04-01

Completion date

Unknown

Last updated

2019-03-25

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 : 1. uncovered self expandable metal stent (diameter 8mm, lenght 5-12 cm, diameter of delivery device 5.9F) insertion to obstructive bile duct 2. simultaneous two stents insertion using

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Histologic confirmed unresectable hilar cholangiocarcinoma or clinically suspicious unresectable hilar cholangiocarcinoma ? Bismuth type II or more degree of bismuth types (II, III, IV) ? predictive suvival period is more than 3 month

Exclusion criteria

Exclusion criteria: ? Not suitable for endoscopic retrograde pancreaticocholedochoscopy ?Over 3 months after endoscopic retrograde pancreaticocholedochoscopy, endoscopic sphincterotomy, or endoscopic retrograde bile duct drainage / endoscopic transnasal bile duct drainage ? uncontrolled blood clotting disorder ? Patients with poor performance status ? Papillary type tumor in the bile duct (Intraductal papillary mucinous neoplasm- bile duct) ? pregnant or lactating status

Design outcomes

Primary

Measure	Time frame
The stent patent period	—

Secondary

Measure	Time frame
The survival period;the technical succsess of metal stent insertion;stents alignment;The clinical success of stent;Early adverse events related to stent insertion;motality related to procedure;Late adverse events related to stent insertion;The reason for stent malfunction;The way for the treatment of stent malfunction	—

Countries

Korea, Republic of

Contacts

Public ContactSeok Jeong

Inha University Hospital

bilstent@naver.com+82-32-890-2542

Outcome results