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.

JRCT ID: jRCTs042180069

Registered date:07/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Distal biliary obstruction caused by unresectable pancreatic cancer
• Date of first enrollment: 20/01/2015
• Target sample size: 90
• Study type: Interventional

Intervention(s)

One-step: Endoscopic biliary SEMS placement
Two-step: Endoscopic biliary SEMS placement after plastic stent

Outcome(s)

• Primary Outcome: Time to SEMS dysfunction
• Secondary Outcome: Early(within 30 days after SEMS placement) and late complication, Overall survival, Bilirubin level decreasing rate, Total costs of SEMS-related interventions

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Naitoh Itaru
• Source(s) of Monetary Support: BOSTON SCIENTIFIC JAPAN CORP.,BOSTON SCIENTIFIC JAPAN CORP.
• Secondary ID(s): UMIN000016010