UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018039
Receipt number R000020897
Scientific Title Practicality of newly improved Dual knife with water-jet function for gastrointestinal ESD
Date of disclosure of the study information 2015/06/23
Last modified on 2021/07/17 14:30:12

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Basic information

Public title

Practicality of newly improved Dual knife with water-jet function for gastrointestinal ESD

Acronym

Practicality of newly improved Dual knife with water-jet function for gastrointestinal ESD

Scientific Title

Practicality of newly improved Dual knife with water-jet function for gastrointestinal ESD

Scientific Title:Acronym

Practicality of newly improved Dual knife with water-jet function for gastrointestinal ESD

Region

Japan


Condition

Condition

early gastric cancer, early colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The efficacy of the Dual knife with a water-jet function for the gastrointestinal ESD

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Primary outcome is to verify the feasibility of mucosal elevation.

Key secondary outcomes

The secondary outcomes include the procedure time, the en bloc resection rate, the number of endoscopic device changes (endoscopic injection needle, different device), the adverse event rate such as post-operative bleeding and perforation.


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

Device,equipment

Interventions/Control_1

We undergo the ESD by the use of the Dual knife with a water-jet function.

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 diagnosed as early gastric cancer and early colorectal cancer and are considered as the indication of ESD treatment.
2)Provided with written informed conscent.

Key exclusion criteria

1)Patients whose lesions are found to be outside the guideline or expanded criteria for ESD.
2)Severe fibrosis.
3)Patients with hematological abnormality.
4)Severe liver dysfunction, Severe renal dysfunction, Severe heart dysfunction.
5)Patients who are pregnant or lactation.
6)Patients without written informed consent.
7)Lesions which are thought to be difficult to resect by ESD because of unstable positioning of endoscope.
8)Patients who are disqualified for the study by physicians
9)Refusal of the trial entry.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Naohisa
Middle name
Last name Yahagi

Organization

Keio University, School of Medicine

Division name

Cancer Center

Zip code

1608582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

TEL

03-3353-1211

Email

yahagi-tky@umin.ac.jp


Public contact

Name of contact person

1st name Tadateru
Middle name
Last name Maehata

Organization

Keio University, School of Medicine

Division name

Cancer Center

Zip code

1608582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

TEL

03-3353-1211

Homepage URL


Email

t2maehata@marianna-u.ac.jp


Sponsor or person

Institute

Keio University, School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Keio University, School of Medicine

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

Keio University

Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.ac.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

2015 Year 06 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

All the lesions were successfully treated by mucosal elevation. The median resected specimen size in stomach and colorectum lesions were 37.3mm and 34.0 mm respectively. The mean procedure time in stomach and colorectum lesions were 36 min and 32.3 min respectively. The en bloc resection rates were 100% in both lesions. The median number of endoscopic device changes in stomach and colorectum lesions were three times and four times respectively. No severe adverse events were observed in both lesions.

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

2014 Year 11 Month 06 Day

Date of IRB

2014 Year 11 Month 19 Day

Anticipated trial start date

2014 Year 11 Month 19 Day

Last follow-up date

2015 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2015 Year 12 Month 31 Day

Date analysis concluded

2015 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 06 Month 23 Day

Last modified on

2021 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020897


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name