UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035099
Receipt number R000039970
Scientific Title Efficacy of forward-viewing echoendoscope for treatment of cholangio-/pancreatico-jejunostomy anastomotic strictures after pancreaticoduodenectomy: A prospective pilot study
Date of disclosure of the study information 2018/12/03
Last modified on 2020/12/29 11:37:00

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Basic information

Public title

Efficacy of forward-viewing echoendoscope for treatment of cholangio-/pancreatico-jejunostomy anastomotic strictures after pancreaticoduodenectomy: A prospective pilot study

Acronym

Efficacy of forward-viewing echoendoscope for treatment of cholangio-/pancreatico-jejunostomy anastomotic strictures after pancreaticoduodenectomy: A prospective pilot study

Scientific Title

Efficacy of forward-viewing echoendoscope for treatment of cholangio-/pancreatico-jejunostomy anastomotic strictures after pancreaticoduodenectomy: A prospective pilot study

Scientific Title:Acronym

Efficacy of forward-viewing echoendoscope for treatment of cholangio-/pancreatico-jejunostomy anastomotic strictures after pancreaticoduodenectomy: A prospective pilot study

Region

Japan


Condition

Condition

cholangio-/pancreatico-jejunostomy anastomotic strictures

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy of a forward-viewing echoendoscope for cholangio-/pancreatico-jejunostomy anastomotic strictures after pancreaticoduodenostomy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The rate of treatment success by a forward-viewing echoendoscope for cholangio-/pancreatico-jejunostomy anastomotic strictures after pancreaticoduodenostomy

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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) a patient after modified Child's pancreatoduodenectomy
2) a patient with suspected Cholangio-/pancreatico-jejunostomy anatomic stricture
3) obtaining written informed consent

Key exclusion criteria

1) Performance Status 4
2) pregnancy
3) a patient with previous surgery for upper digestive tract, pancreas, biliary tract expect for modified Child's pancreatoduodenectomy
4) patients considered ineligible for this study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Hirotoshi
Middle name
Last name Ishiwatari

Organization

Shizuoka cancer center

Division name

Endoscopy

Zip code

4118777

Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka

TEL

0559895222

Email

ishihiro481019@gmail.com


Public contact

Name of contact person

1st name Hirotoshi
Middle name
Last name Ishiwatari

Organization

Shizuoka Cancer Center

Division name

Endoscopy

Zip code

411-8777

Address

Nagaizumi

TEL

08057203898

Homepage URL


Email

ishihiro481019@gmail.com


Sponsor or person

Institute

Shizuoka cancer center

Institute

Department

Personal name



Funding Source

Organization

Shizuoka cancer center

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

Shizuoka cancer center

Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka

Tel

0559895222

Email

ishihiro481019@gmail.com


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 12 Month 03 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

Open public recruiting

Date of protocol fixation

2018 Year 11 Month 24 Day

Date of IRB

2018 Year 11 Month 06 Day

Anticipated trial start date

2018 Year 12 Month 03 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2018 Year 12 Month 01 Day

Last modified on

2020 Year 12 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039970


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name