UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028667
Receipt number R000028465
Scientific Title Confocal laser endoscopy for hepatobiliary pancreatic surgery
Date of disclosure of the study information 2017/08/15
Last modified on 2019/05/06 06:29:36

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Basic information

Public title

Confocal laser endoscopy for hepatobiliary pancreatic surgery

Acronym

Confocal laser endoscopy for hepatobiliary pancreatic surgery

Scientific Title

Confocal laser endoscopy for hepatobiliary pancreatic surgery

Scientific Title:Acronym

Confocal laser endoscopy for hepatobiliary pancreatic surgery

Region

Japan


Condition

Condition

neoplasm in heapato-biliary-panreatic system

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the usefulness of confocal lazer endomicroscopy for perioperative diagnosis in hepato-biliary-pancreatic surgery

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Comparison between diagnosis of confocal lazer endomicroscopy with the pathological findings

Key secondary outcomes

Comparison between findings of confocal lazer endomicroscopy with pathological findings


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine Device,equipment

Interventions/Control_1

Intravenous injection of fluorescein (300mg) and observe bile duct by confocal laser endomicroscopy

Interventions/Control_2


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)Patients who are undergoing HPB surgery
2)patients from whom informed consent was obtained

Key exclusion criteria

Patients who have allergy for fluorecein, in poor general condition, severe diabetes, severe heart disease, severe cerebral arterial disease, severe respiratory disease, severe hypertention, pregnancy, liver cirrhosis, or phenocromocytoma.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kiyoshi Hasegawa

Organization

Tokyo university

Division name

Hepato-Biliary-Pancreatic Surgery Division

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan

TEL

0338155411

Email

kihase-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masaru Matsumura

Organization

Tokyo university

Division name

Hepato-Biliary-Pancreatic Surgery Division

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan

TEL

0338155411

Homepage URL


Email

MATSUMURAM-SUR@h.u-tokyo.ac.jp


Sponsor or person

Institute

University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

University of Tokyo

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

2017 Year 08 Month 15 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

2017 Year 01 Month 06 Day

Date of IRB

2017 Year 01 Month 06 Day

Anticipated trial start date

2017 Year 02 Month 01 Day

Last follow-up date

2018 Year 05 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

2017 Year 08 Month 15 Day

Last modified on

2019 Year 05 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028465


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name