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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000388
Receipt No. R000000391
Scientific Title Japanese multicenter, randomized trial of endoscopic stenting for the nonresectable pancreatic head cancer (JM-Test)
Date of disclosure of the study information 2006/04/01
Last modified on 2009/10/01

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Basic information
Public title Japanese multicenter, randomized trial of endoscopic stenting for the nonresectable pancreatic head cancer (JM-Test)
Acronym JM-Test
Scientific Title Japanese multicenter, randomized trial of endoscopic stenting for the nonresectable pancreatic head cancer (JM-Test)
Scientific Title:Acronym JM-Test
Region
Japan

Condition
Condition nonresectable pancreatic head cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The bile duct is a passage that carries bile secreted by the liver. Running out of the liver, it enters the pancreas and then united with the pancreatic duct to forms a common bile duct opening into the duodenum. When the duct is clogged somewhere, the bile is prevented to flow, which causes hepatic diseases or jaundice. The accumulated bile in the duct, due to a raised internal pressure, flows back to the hepatic sinusoid and eventually into the blood vessels, causing jaundice. The patients along with choloangistis likely develop bacteriemia, which rapidly progresses to ichorrhemia, if left untreated or under immune compromise with aging or underlying diseases like diabetes and malignant tumors. The endoscopic bile duct drainage is performed for relief of jaundice, hepatapathy, and defective circulation in the intestine. The stent, which is placed to create an internal fistula for treatment of unresectable malignant distal biliary obstruction, has been conventionally made of plastic. However the plastic stent is now being replaced by Uncovered Metallic Stent(UMS) and the Covered Metallic Stent (CMS). As for the CMS, a randomized clinical study has been performed in Japan, reporting that CMS is superior to UMS in terms of patency. However CMS has not gained global acceptance yet. CMS has advantages that removal of the CMS can be performed even the duct is being clogged and that it has long-term patency. On the other hand, complications associated with the stent such as cholecystitis, pancreatitis, and displacements of the stent have been pointed out. Then we perform clinical trials targeting only pancreatic head cancer, a randomized study of Plastic stent versus CMS in treating distal biliary obstruction caused by an unresectable cancer in the pancreatic head. The purpose of the trials is to clarify which is the best choice, analyzing cost effectiveness and complications.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Stent patency and occulusion rate
Key secondary outcomes Survival, Cost effectiveness, Types and frequency of complications

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
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
Device,equipment
Interventions/Control_1 When a tumor mass is detected based on diagnostic imaging including US and CT, and tumor-related obstructive jaundice is suspected, we determine whether it is pancreas cancer or not by endoscopic pancreatic cholangiography and perform endoscopic retrograde biliary drainage. At this stage, in principle, endoscopic nasobiliary biliary drainage (ENBD) is performed or the plastic stent is placed. While alleviating jaundice, we determine if surgery can be carried out or not. Meanwhile, patients whose tumor is determined as unresectable up to this point are enrolled in the trials for placement of a designated stent(Plastic stent).
Interventions/Control_2 When a tumor mass is detected based on diagnostic imaging including US and CT, and tumor-related obstructive jaundice is suspected, we determine whether it is pancreas cancer or not by endoscopic pancreatic cholangiography and perform endoscopic retrograde biliary drainage. At this stage, in principle, endoscopic nasobiliary biliary drainage (ENBD) is performed or the plastic stent is placed. While alleviating jaundice, we determine if surgery can be carried out or not. Meanwhile, patients whose tumor is determined as unresectable up to this point are enrolled in the trials for placement of a designated stent(Covered Metallic Stent).
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients with unresectable pancreatic head cancer causing stricture of the bile duct
Patients with stricture in mid or lower bile duct
Patients with cancer radically unresectable, Patients who will not able to endure surgery. Patients refusing to undergo surgery
Patients with cancer>=stage 3 of TNM classification of UICC
Patients who fully understand and are willing to give a written informed consent about participation.
Key exclusion criteria Patients with cancer endoscopically accessible
Patients with cancer endoscopically accessible
Patients with performance status 4 (See Appendix)
Patients with severe complications on other organs (>=stage 3 of ASA classification) except dialysis patients
Patients without an informed consent
Patients determined as not eligible by doctors in charge.
Patients with intraductal papillary-mucinous tumor:(IPMT)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromitsu Isayama
Organization Faculty of Medicine, University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiromitsu Isayama
Organization Faculty of Medicine, University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Faculty of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization nothing
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
2006 Year 04 Month 01 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 Completed
Date of protocol fixation
2005 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 10 Month 01 Day
Last follow-up date
2007 Year 10 Month 01 Day
Date of closure to data entry
2008 Year 11 Month 01 Day
Date trial data considered complete
2009 Year 05 Month 01 Day
Date analysis concluded
2009 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 04 Month 01 Day
Last modified on
2009 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000391

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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