UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000009231
Receipt number	R000010826
Scientific Title	Prospective, Consecutive, Single-Center Study Western (Greek) Single-Center Experience of Endoscopic Submucosal Dissection (ESD) for Early Gastrointestinal Neoplasia. That is really possible in a Greek General Hospital.
Date of disclosure of the study information	2012/10/31
Last modified on	2015/04/02 09:22:45

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Basic information

Public title

Prospective, Consecutive, Single-Center Study
Western (Greek) Single-Center Experience of Endoscopic Submucosal Dissection (ESD) for Early Gastrointestinal Neoplasia. That is really possible in a Greek General Hospital.

Acronym

Prospective, Western (Greek) Single-Center Study of ESD for early GI neoplasms

Scientific Title

Scientific Title:Acronym

Prospective, Western (Greek) Single-Center Study of ESD for early GI neoplasms

Region

Europe

Condition

Early (upper mucosal) esophageal cancer, Barrett esophagus, early (mucosal or upper submucosal) gastric cancer, early (mucosal or slightly invasive submucosal) colon cancer and lateral spreading colorectal tumors (LST)

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

The aim of the present prospective, consecutive, single-hospital study is to assess the safety, feasibility, effectiveness and outcomes of using upper as well as lower ESD for the treatment of early GI neoplasms, in a Greek Single-Hospital setting.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase I,II

Assessment

Primary outcomes

Endoscopic 'en bloc' and complete pathological R0 resection.

Key secondary outcomes

Tumor location, tumor size, duration of ESD, hospitalization time, morbidity, management of complications and .

Base

Study type

Interventional

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Endoscopic submucosal dissection (ESD)

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Early (upper mucosal) esophageal cancer.
2) Barrett esophagus.
3) Early (mucosal or upper submucosal) gastric cancer.
4) Early (mucosal or slightly invasive submucosal) colon cancer.
5) Lateral spreading colorectal tumors (LST).
6) Sufficient organ functions.
7) Written informed consent.

Key exclusion criteria

1) severe systemic disease with therapy indicated.

Target sample size

200

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name A. Hatzitolios

Organization

AHEPA University Hospital, Medical School Aristotle's University of Thessaloniki

Division name

1st Propedeutic Department of Internal Medicine, Endoscopy Department

Zip code

Address

Stilp. Kiriakidi 1, PC 54636 Thessaloniki Greece

TEL

00306937017432

Email

haruinoue777@yahoo.co.jp

Public contact

Name of contact person

1st name

Middle name

Last name Nikolas Eleftheriadis

Organization

Medical School Aristotle's University of Thessaloniki

Division name

AHEPA University Hospital

Zip code

Address

Stilp. Kiriakidi 1, PC 54636 Thessaloniki Greece

TEL

00302310993111

Homepage URL

Email

haruinoue777@yahoo.co.jp

Sponsor or person

Institute

AHEPA University Hospital, Medical School Aristotle's University of Thessaloniki

Institute

Department

Personal name

Funding Source

Organization

AHEPA University Hospital, Medical School Aristotle's University of Thessaloniki

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Other related organizations

Co-sponsor

Showa University Northern Yokohama Hospital

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2012 Year 10 Month 31 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

2012 Year 10 Month 30 Day

Date of IRB

Anticipated trial start date

2012 Year 10 Month 30 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2012 Year 10 Month 31 Day

Last modified on

2015 Year 04 Month 02 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010826

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

1st name
Middle name
Last name	Nikolas Eleftheriadis