UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023297
Receipt number R000026853
Scientific Title A Multicenter, Prospective Randomized Study comparing Fully Covered Metal Stent and Plastic Stent for Preoperative Biliary Drainage in Resectable Pancreatic Cancer
Date of disclosure of the study information 2016/07/23
Last modified on 2021/11/08 12:43:26

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Basic information

Public title

A Multicenter, Prospective Randomized Study comparing Fully Covered Metal Stent and Plastic Stent for Preoperative Biliary Drainage in Resectable Pancreatic Cancer

Acronym

Comparison of Metal Stent with Plastic Stent for Preoperative Biliary Drainage in Resectable Pancreatic Cancer

Scientific Title

A Multicenter, Prospective Randomized Study comparing Fully Covered Metal Stent and Plastic Stent for Preoperative Biliary Drainage in Resectable Pancreatic Cancer

Scientific Title:Acronym

Comparison of Metal Stent with Plastic Stent for Preoperative Biliary Drainage in Resectable Pancreatic Cancer

Region

Japan Asia(except Japan)


Condition

Condition

Obstructive jaundice caused by resectable pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare preliminary placement of FCMS and PS for obstructive jaundice caused by resectable pancreatic cancer with preoperative endoscopic drainage through a randomized musticenter controlled study and to evaluate the rate of re-intervention as well as post operative complication.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Rate of re-intervention related to stent during the time from drainage to surgical operation

Key secondary outcomes



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


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Fully covered metal stent cohort

Interventions/Control_2

Plastic stent cohort

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

Patients are eligible for this Study if they meet all the criteria shown below.
Patients who are over 20 years old
Patients who are suspected to have a carcinoma of the head of the pancreas which is determined to be resectable from the image, and a resection is scheduled as of ERCP conduction timing.
Patients who show obstructive jaundice caused by biliary stricture
Patients with stricture occurring at middle or lower part of the biliary
Patients for whom NO preoperative chemical radiation therapy is planned

Key exclusion criteria

Patients are to be excluded from this Study if they conflict with any of the criteria shown below
Patients who have previously received the procedure of cholecystectomy or endoscopic sphincterotomy
Patients who score 4 in Performance Status
Patients with serious complication on other organ(s): Higher than 3 with ASA category (dialyzed patients are also excluded)
Patients judged to have less than 3 months of life expectancy

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takao Itoi

Organization

Tokyo Medical University Hospital

Division name

Department of Gastroenterology

Zip code


Address

6-7-1 Nishi-Sinjyuku-ku, Tokyo

TEL

03-3342-6111

Email

itoi@tokyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takayoshi Tsuchiya

Organization

Tokyo Medical University Hospital

Division name

Department of Gastroenterology

Zip code


Address

6-7-1 Nishi-Sinjyuku-ku, Tokyo

TEL

03-3342-6111

Homepage URL


Email

tsuchiya@tokyo-med.ac.jp


Sponsor or person

Institute

Tokyo Medical University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

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

2016 Year 07 Month 23 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

2016 Year 02 Month 26 Day

Date of IRB

2016 Year 02 Month 26 Day

Anticipated trial start date

2016 Year 08 Month 01 Day

Last follow-up date

2020 Year 08 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

2016 Year 07 Month 22 Day

Last modified on

2021 Year 11 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026853


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name