UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000759
Receipt number R000000854
Scientific Title Endoscopic resection for laterally spreading tumor (LST) -(endoscopic submucosal dissecion (ESD) vs. endoscopic mucosal resection)-
Date of disclosure of the study information 2007/07/04
Last modified on 2014/03/12 17:49:57

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Basic information

Public title

Endoscopic resection for laterally spreading tumor (LST)
-(endoscopic submucosal dissecion (ESD) vs. endoscopic mucosal resection)-

Acronym

endoscopic resection for LST (ESD vs. EMR)

Scientific Title

Endoscopic resection for laterally spreading tumor (LST)
-(endoscopic submucosal dissecion (ESD) vs. endoscopic mucosal resection)-

Scientific Title:Acronym

endoscopic resection for LST (ESD vs. EMR)

Region

Japan


Condition

Condition

early colorectal cancer or adenoma
(laterally spreading tumor (LST))

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the appropriate method of endoscopic resection for laterally spreading tumor.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the incidence of local recurrence after endoscopic resection

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Group A. ESD group
1. The solution of a mixture of Glyceol and 1% 1900-KDa hyaluronic acid preparation is injected into the submucosal layer.
2. Mucosal incision is started with the knife for ESD.
3. The lesion is resected with submucosal dissection.

Interventions/Control_2

Group B. EMR group
1. The solution of normal saline is injected into the submucosal layer.
2. The lesion is resected with an electrosurgical snare.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Patients who were diagnosed as laterally spreading tumor (granular type:LST-G)
2.Patients who had preoperative diagnoses of mucosal or slight submucosally invasive neoplasms.
3.Patients whose lesion was diagnosed as 20-40mm in diameter.
4. Patients who provided written informed consent.

Key exclusion criteria


1.Patients with serious complication.
2.Patients who were judged inappropriate by their physicians.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuhiro Fujishiro

Organization

The University of Tokyo

Division name

Department of Gastroenterology

Zip code


Address

7-3-1, Hongo, Bunkyoku, Tokyo, 113-8655

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

The University of Tokyo

Division name

Department of Gastroenterology

Zip code


Address


TEL

03-3815-5411

Homepage URL


Email



Sponsor or person

Institute

The University of Tokyo, Department of Gastroenterology

Institute

Department

Personal name



Funding Source

Organization

none

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


Address


Tel


Email



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

2007 Year 07 Month 04 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

Completed

Date of protocol fixation

2007 Year 04 Month 20 Day

Date of IRB


Anticipated trial start date

2007 Year 05 Month 01 Day

Last follow-up date

2010 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2007 Year 07 Month 03 Day

Last modified on

2014 Year 03 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000854


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name