UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038101
Receipt number R000043430
Scientific Title The validity of endoscopic resection for hemicircumferential large colorectal laterally spreading tumors.
Date of disclosure of the study information 2019/09/26
Last modified on 2019/09/26 08:30:20

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Basic information

Public title

The validity of endoscopic resection for hemicircumferential large colorectal laterally spreading tumors.

Acronym

ESD for large hemicircumferential LST

Scientific Title

The validity of endoscopic resection for hemicircumferential large colorectal laterally spreading tumors.

Scientific Title:Acronym

ESD for large hemicircumferential LST

Region

Japan


Condition

Condition

early colorectal cancer/adenoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy of endoscopic resection for the treatment of large hemicircumferential colorectal laterally spreading tumor

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

En-bloc and R0 resection rate

Key secondary outcomes

Procedure time dissection speed complication rate


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

endoscopic resection

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with colorectal laterally spreading tumor larger than 50mm, beyond hemicircumferential invasion

Key exclusion criteria

1. Hb < 9 g/dl
2. Pregnant women
3. Patients with severe heart/kidney/liver diseases
4. Patients in disagreement with informed consent
5. Others

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Eiji
Middle name
Last name Sakai

Organization

NTT Medical Center Tokyo

Division name

Gastrointestinal Endoscopy

Zip code

141-8625

Address

5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan

TEL

03-3448-6111

Email

eiji525@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Eiji
Middle name
Last name Sakai

Organization

NTT Medical Center Tokyo

Division name

Gastrointestinal Endoscopy

Zip code

141-8625

Address

5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan

TEL

03-3448-6111

Homepage URL


Email

eiji525@yokohama-cu.ac.jp


Sponsor or person

Institute

NTT Medical Center Tokyo

Institute

Department

Personal name



Funding Source

Organization

NTT Medical Center Tokyo

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

NTT Medical Center Tokyo

Address

5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan

Tel

03-3448-6111

Email

eiji525@yokohama-cu.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

2019 Year 09 Month 26 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

2019 Year 08 Month 01 Day

Date of IRB

2019 Year 08 Month 01 Day

Anticipated trial start date

2019 Year 09 Month 26 Day

Last follow-up date

2020 Year 12 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

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=R000043430


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name