UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038111
Receipt number R000043445
Scientific Title Flexible endoscopic treatment for Zenker's diverticulum: Multicenter prospective study.
Date of disclosure of the study information 2019/09/30
Last modified on 2019/09/26 16:17:37

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Basic information

Public title

Flexible endoscopic treatment for Zenker's diverticulum: Multicenter prospective study.

Acronym

FESD for ZD

Scientific Title

Flexible endoscopic treatment for Zenker's diverticulum: Multicenter prospective study.

Scientific Title:Acronym

FESD for ZD

Region

Japan


Condition

Condition

Zenker's diverticulum

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess prospectively short and long-term outcome of existing flexible endoscopic treatment of ZD including success, complication and recurrence.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Clinical success rate

Key secondary outcomes



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

flexible endoscopic septum division (FESD)

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

- Diagnosed as ZD with symptoms
- ASA score of > 3
- age of more than 20

Key exclusion criteria

- previous upper gastrointestinal surgery
- previous treatments for ZD (i.e. surgery, endoscopic stapling, CO2 laser treatment, FESD)
- presence of significant esophageal dysmotility disorder, such as achalasia
- presence of psychiatric comorbidities
- pregnancy
- failure to provide written consent

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Toshio
Middle name
Last name Kuwai

Organization

National Hospital Organization Kure Medical Center and Chugoku Cancer Center

Division name

Department of Gastroenterology

Zip code

737-0023

Address

3-1 Aoyama-cho, Kure, Japan.

TEL

+81-823-22-3111

Email

kuwai.toshio.ur@mail.hosp.go.jp


Public contact

Name of contact person

1st name Toshio
Middle name Kuwai
Last name Kuwai

Organization

National Hospital Organization Kure Medical Center and Chugoku Cancer Center

Division name

Department of Gastroenterology

Zip code

737-0023

Address

3-1 Aoyama-cho, Kure, Japan.

TEL

+81-823-22-3111

Homepage URL


Email

kuwai.toshio.ur@mail.hosp.go.jp


Sponsor or person

Institute

National Hospital Organization Kure Medical Center and Chugoku Cancer Center

Institute

Department

Personal name



Funding Source

Organization

N/A

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

National Hospital Organization Kure Medical Center and Chugoku Cancer Center

Address

3-1 Aoyama-cho, Kure 737-0023 Japan.

Tel

+81-823-22-3111

Email

kuwai.toshio.ur@mail.hosp.go.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

2019 Year 09 Month 30 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

Preinitiation

Date of protocol fixation

2019 Year 09 Month 26 Day

Date of IRB


Anticipated trial start date

2020 Year 04 Month 01 Day

Last follow-up date

2024 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 09 Month 26 Day

Last modified on

2019 Year 09 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043445


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name