UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031051
Receipt number R000035053
Scientific Title Phase I/II study of EUS-HES(EUS-guided hepaticoenterostomy) for malignant biliary hilar stenosis
Date of disclosure of the study information 2018/01/29
Last modified on 2022/08/03 12:02:39

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Basic information

Public title

Phase I/II study of EUS-HES(EUS-guided hepaticoenterostomy) for malignant biliary hilar stenosis

Acronym

Phase I/II study of EUS-HES for malignant biliary hilar stenosis

Scientific Title

Phase I/II study of EUS-HES(EUS-guided hepaticoenterostomy) for malignant biliary hilar stenosis

Scientific Title:Acronym

Phase I/II study of EUS-HES for malignant biliary hilar stenosis

Region

Japan


Condition

Condition

malignant biliary hilar stenosis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To confirm the safety and efficacy of EUS-HES for malignant biliary hilar stenosis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety
Clinical efficacy

Key secondary outcomes

Rate of adverse events
Grade of adverse events
Re-intervention


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

biliary drainage

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Biliary drainage required for biliary hilar obstruction secondary to unresectable malignant tumor
2.No tumor extension into the puncture site
3.Maintenance of major organ function
4.Informed consent provided by the patient.

Key exclusion criteria

1.Not primary drainage
2.Massive hilar invasion
3.With cholangitis
4.Pregnant
5.Easy bleeding
6.Doctor disagree

Target sample size

18


Research contact person

Name of lead principal investigator

1st name Kazuo
Middle name
Last name Hara

Organization

Aichi Cancer Center Hospital

Division name

Gastroenterology

Zip code

4648681

Address

1-1, kanokoden, chikusa-ku,Nagoya

TEL

052-762-611

Email

khara@aichi-cc.jp


Public contact

Name of contact person

1st name Nozomi
Middle name
Last name Okuno

Organization

Aichi Cancer Center Hospital

Division name

Gastroenterology

Zip code

4648681

Address

1-1, kanokoden, chikusa-ku,Nagoya

TEL

052-762-611

Homepage URL


Email

nokuno@aichi-cc.jp


Sponsor or person

Institute

Aichi Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Aichi Cancer Center Hospital

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

Aichi Cancer Center Hospital

Address

1-1, kanokoden, chikusa-ku,Nagoya

Tel

052-762-6111

Email

irb@aichi-cc.jp


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

2018 Year 01 Month 29 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

Terminated

Date of protocol fixation

2018 Year 01 Month 04 Day

Date of IRB

2018 Year 01 Month 29 Day

Anticipated trial start date

2018 Year 01 Month 29 Day

Last follow-up date

2022 Year 01 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 29 Day

Last modified on

2022 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035053


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name