A prospective randomized controlled study of "one-step" vs "two-step" self-expandable metallic stent placement for the management of distal biliary obstruction by unresectable pancreatic cancer.

A prospective randomized controlled study of "one-step" vs "two-step" self-expandable metallic stent placement for the management of distal biliary obstruction by unresectable pancreatic cancer. - A prospective randomized controlled study of "one-step" vs "two-step" self-expandable metallic stent placement for the management of distal biliary obstruction by unresectable pancreatic cancer.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016010

Enrollment

Registered

2014-12-19

Start date

2014-12-19

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

Distal biliary obstruction caused by unresectable pancreatic cancer

Interventions

one-step SEMS placement two-step SEMS placement

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Written informed consent obtained 2)Age over 20 years old 3)Distal biliary obstruction with no history of biliary drainage caused by pancreatic cancer 4)Confirmation of unresectable pancreatic cancer 5)Endoscopic transpapillary SEMS placement

Exclusion criteria

Exclusion criteria: 1)Prognosis will be within 30 days 2)Having post gastrectomy with Billoth II or Roux-en-Y reconstruction 3)After percutaneous biliary drainage 4)Having history of SEMS placement for biliary obstruction 5)Having active infectious disease except acute cholangitis 6)Having severe acute cholangitis according to Tokyo Guidelines 7)Patients with the allergy to metal 8)Pregnant women or those suspected of pregnancy 9)Patients considered ineligible by attending physicians

Design outcomes

Primary

Measure	Time frame
Time to SEMS dysfunction	—

Secondary

Measure	Time frame
Early(within 30 days after SEMS placement) and late complication, Overall survival, Bilirubin level decreasing rate, Total costs of SEMS-related interventions	—

Countries

Japan

Contacts

Public ContactItaru Naitoh

Nagoya City University Graduate School of Medical Sciences Department of Gastroenterology and Metabolism

inaito@med.nagoya-cu.ac.jp052-853-8211

Outcome results

None listed

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

A prospective randomized controlled study of &quot;one-step&quot; vs &quot;two-step&quot; self-expandable metallic stent placement for the management of distal biliary obstruction by unresectable pancreatic cancer.