Efficacy of Multihole Self-expandable Metal Stent For Palliative Treatment of Malignant Distal Biliary Stricture

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20200819002

Enrollment

156

Registered

2020-08-19

Start date

2018-01-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

None listed

Interventions

MHSEMS is the newly designed stents to treat the bile duct obstruction by inserted across the stricture site at bile duct through the endoscopic retrograde cholangiopancreatography (ERCP) procedure. T

Experimental Device,Placebo Comparator Device

Multihole Self-expandable metal stent (MHSEMS),Fully covered Self-expandable metal stent (FCSEMS) and uncovered Self-expandable metal stent (UCSEMS)

Eligibility

Sex/Gender

All

Age

18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1.Age more than 18 years 2.Clinical obstructive jaundice from potentially unresectable malignant distal biliary stricture diagnosed by CT or MRI or ERCP with or without cyto-pathological confirmation 3.Upper margin of the stricture is located below hilar at least 10 mm 4.No prior biliary drainage by other methods

Exclusion criteria

Exclusion criteria: Exclusion criteria 1.Pregnancy 2.Contraindications for ERCP

Design outcomes

Primary

Measure	Time frame
Recurrent biliary obstruction (event) From stent insertion until event occur or patients death Time to recurrent biliary obstruction	—

Secondary

Measure	Time frame
Clinical success rate 2 weeks after stent insertion Rate of successful biliary bypass in each group,Complications From stent insertion Rate of post ERCP complications; pancreatitis, cholecystitis, cholangitis, and bleeding,Etiology of recurrent biliary obstruction From stent insertion to clinically detected recurrent obstructive jaundice Same as outcome name	—

Countries

Thailand

Contacts

Public ContactSanti Kulpatcharapong

Chulalongkorn University

kul.santi@gmail.com66817521252

Outcome results