A randomized controlled trial comparing 10mm metallic stent versus 14mm metallic stent for distal biliary obstruction caused by pancreatic carcinoma

A randomized controlled trial comparing 10mm metallic stent versus 14mm metallic stent for distal biliary obstruction caused by pancreatic carcinoma - A randomized controlled trial comparing 10mm metallic stent versus 14mm metallic stent for distal biliary obstruction caused by pancreatic carcinoma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000035387

Enrollment

120

Registered

2019-02-01

Start date

2019-02-01

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

Pancreatic cancer

Interventions

Biliary metallic stent with 10mm in size Biliary metallic stent with 14mm in size

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with jaundice or liver dysfunction (2) Pathologically confirmed as cancer (3) No indication for surgical resection (4) The diameter of dilated bile duct >= 14mm (5) Distal bile duct obstruction which is not reached in the hilar region (6) Performance status(ECOG) is 0~1. (7) Prognosis will be >= 4 months.

Exclusion criteria

Exclusion criteria: (1) Patients with history of gastrectomy and reconstruction other than Billroth I anastomosis (2) Duodenal obstruction in anal side of major papilla (3) Patients with history of insertion of biliary metallic stent (4) ASA >= 3 (5) Patients with acute pancreatitis or exacerbation of chronic pancreatitis (6) Patients with liver cirrhosis (7) Patients with Platelet count=< 50,000 mm3 (8) A participating doctor thinks the patient is inappropriate for this study.

Design outcomes

Primary

Measure	Time frame
Time to recurrent biliary obstruction (TRBO)	—

Countries

Japan

Contacts

Public ContactYumiko Honda

Shizuoka Cancer Center Clinical Research Center

yu.honda@scchr.jp055-989-5222

Outcome results

None listed

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