A prospective randomized comparative study of a novel anti-reflux metal stent versus partial covered metal stent in patients with inoperable distal malignant biliary strictures

A prospective randomized comparative study of a novel anti-reflux metal stent versus partial covered metal stent in patients with inoperable distal malignant biliary strictures - Comparision of a novel anti-reflux metal stent with partial covered metal stent for distal malignant biliary strictures

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012734

Enrollment

132

Registered

2013-12-31

Start date

2013-12-31

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Inoperable distal malignant biliary stircutres 1) Common bile duct cancer 2) Pancreatic head cancer 3) Gallbladder cancer 4) Other metastatic malignant biliary strictures

Interventions

Biliary drainage with a novel anti-reflux metal stent Biliary drainage with a conventional partial covered metal stent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Providing informed consent 2) Inoperable distal malignant biliary strictures 3) Distal malignant biliary strictures with high operative risk 4) Distal malignant biliary strictures on imaging studies 5) Histopathologically confirmed as malignancy 6) Stricture in distance above 2 cm from the bifurcation of bile duct

Exclusion criteria

Exclusion criteria: 1) Refusal of this study 2) Plan for curative or palliative surgery 3) Stricture in distance within 2 cm from the bifurcation of bile duct 4) Risk of bleeding: PT-INR > 1.5, normal 0.85-1.25 or platelet count < 80,000/mm3, normal 150,000-450,000/mm3 5) Pregnant or breast-feeding women 6) Performance status < 3 (scales of the Eastern Cooperative Oncology Group)

Design outcomes

Primary

Measure	Time frame
Stent occlusion	—

Secondary

Measure	Time frame
Clinical success Complications Stent patency	—

Countries

Asia(except Japan)

Contacts

Public ContactHyun Jong Choi

SoonChunHyang University School of Medicine Digestive Disease Center and Research Institute

joseph@schmc.ac.kr+82-32-621-5211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026