UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000388 |
|---|---|
| Receipt number | 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 20:28:42 |
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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
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
Sponsor or person
Institute
Faculty of Medicine, University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000391
