A prospective randomized controlled multicenter trial of safety and efficacy of endoscopic sphincterotomy in placement of covered self-expandable metallic stent for biliary obstruction from unresectable pancreatic cancer.

A prospective randomized controlled multicenter trial of safety and efficacy of endoscopic sphincterotomy in placement of covered self-expandable metallic stent for biliary obstruction from unresectable pancreatic cancer. - A prospective randomized controlled multicenter trial of safety and efficacy of endoscopic sphincterotomy in placement of stent.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004044

Enrollment

200

Registered

2010-08-16

Start date

2009-12-01

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

biliary obstruction from unresectable pancreatic cancer

Interventions

EST non EST

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The biliary tract obstruction from pancreatic cancer is diagnosed based on the imaging findings and biliary drainage is necessary for the obstruction. 2. Acute cholangitis is treated successfully by systemic antibiotics with or without percutaneous or transpapillary drainage of biliary truct. 3. The involvement of pancreatic cancer to the region of papilla of Vater is not detected by the endoscopic procedure. 4. Pancreatic cancer which is histologically or cytologically proven malignancy. 5. Pancreatic cancer is considered unresectable owing to advanced stage, cormobidity and/or age. 6. The bile duct obstruction is not found in the hilar region. 7. Patients fully understand and are willing to give a written informed consent about participation.

Exclusion criteria

Exclusion criteria: 1. Performance status is 4. 2. Japan Coma Scale (JCS) >=I-1. 3. Severe heart disease. 4. Severe lung disease. 5. PT INR >= 1.5. 6. Plt =< 50,000 mm3. 7. Patients who can not discontinue anticoagulant or antiplatelet drugs. 8. Age is lower than 20 years. 9. Patients with history of insertion of biliay stent which is larger bore than 8 Fr. 10. Patients with history of previous endoscopic sphincterotomy. 11. Patients with Billroth II or Roux-en-Y reconstruction after gastrectomy. 12. Patients with pancreaticobiliary maljunction. 13. Patients with distal intestinal obstruction from ampulla of Vater. 14. Patients considered ineligible for this study.

Design outcomes

Primary

Measure	Time frame
early complications rate (within 30 days following c-SEMS placement)	—

Secondary

Measure	Time frame
1. dulation of endoscopy 2. success rate of c-SEMS placement and and drainage 3. late complicaions rate (from 30 days to stent replacement or detah) 4. patency dulation of c-SEMS 5. cause of c-SEMS obstruction	—

Countries

Japan

Outcome results

None listed

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