UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004044
Receipt No. R000003564
Scientific Title 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.
Date of disclosure of the study information 2010/08/16
Last modified on 2014/07/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title 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.
Acronym A prospective randomized controlled multicenter trial of safety and efficacy of endoscopic sphincterotomy in placement of stent.
Scientific Title 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.
Scientific Title:Acronym A prospective randomized controlled multicenter trial of safety and efficacy of endoscopic sphincterotomy in placement of stent.
Region
Japan

Condition
Condition biliary obstruction from unresectable pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate clinical safety and efficacy of endoscopic sphincterotomy (EST) in placement of covered self-expandable metallic stent (c-SEMS) for biliary obstruction from unresectable pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes early complications rate (within 30 days following c-SEMS placement)
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 EST
Interventions/Control_2 non EST
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Hayashi
Organization Sapporo medical university
Division name Fourth Department of Internal Medicine
Zip code
Address South-1, West-16, Chuo-ku Sapporo, Hokkaido, 060-8556, Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Sapporo Medical University
Division name Fourth Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email thayashi69@sapmed.ac.jp

Sponsor
Institute Fourth Department of Internal Medicine, Sapporo medical university
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2009 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2012 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 16 Day
Last modified on
2014 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003564

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.