UMIN-CTR Clinical Trial

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

nonresectable pancreatic head cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Stent patency and occulusion rate

Key secondary outcomes

Survival, Cost effectiveness, Types and frequency of complications

Study type

Interventional

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

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

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

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

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

Institute

Faculty of Medicine, University of Tokyo

Institute

Department

Personal name

Organization

nothing

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2006

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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