UMIN-CTR Clinical Trial

Public title

A pilot study of delineation of the horizontal extent of gastric cancer by Helicobacter pylori eradication or non-eradication.

Acronym

HP delineation study

Scientific Title

A pilot study of delineation of the horizontal extent of gastric cancer by Helicobacter pylori eradication or non-eradication.

Scientific Title:Acronym

HP delineation study

Region

Japan

Condition

gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of this study is to verify the preoperative delineation of gastric cancer by Helicobacter pylori (HP) eradication or non-eradication in the case that underwent endoscopic submucosal dissection (ESD) for gastric cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The proportion of the delineation of the gastric cancer according to HP eradication or non-eradication that we able to diagnose exactly.

Key secondary outcomes

The proportion of the delineation of the gastric cancer according to a period of HP eradication that we were able to diagnose exactly.
Frequency of the metachronous gastric cancers according to HP eradication or non-eradication.
The proportion of the gastric cancer that fullfill tumor indication for endoscopic resection of Japanese gastric cancer treatment guidelines 2010 in semiannual surveillance after ESD.
In addition, we will conduct exploratory and comprehensive analyses.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Candidate patients have to meet all the following inclusion criteria to participate in the study.
(a)Histpathological investigation of the biopsy must confirm gastric cancer (Category 4 or 5 in the revised Vienna classification).
(b)The gastric cancer will be treated by ESD for the first time.
(c)Patients should be 20 years old and over.

Key exclusion criteria

(a)Patients who had undergone gastrectomy.
(b)Patients in whom a gastric cancer is located in the junction of the esophagus and the stomach.
(c)At the time of registration, HP-negative patients who have not had HP eradication.
(d)At the time of registration, HP-negative patients in whom HP eradication is unidentified.
(e)Patients who do not give informed consent.

Target sample size

Name of lead principal investigator

1st name
Middle name
Last name	Hisashi Doyama

Organization

Ishikawa prefectural central hospital

Division name

Department of Gastroenterology

Zip code

Address

2-1 Kuratukihigashi Kanazawa-shi Ishikawa-ken

TEL

076-237-8211

Email

doyama.134@ipch.jp

Name of contact person

1st name
Middle name
Last name	Kei Tominaga

Organization

Ishikawa prefectural central hospital

Division name

Department of Gastroenterology

Zip code

Address

2-1 Kuratukihigashi Kanazawa-shi Ishikawa-ken

TEL

076-237-8211

Homepage URL

Email

keipoo9004@yahoo.co.jp

Institute

Ishikawa prefectural central hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

03

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2015

Year

01

Month

15

Day

Date of IRB

Anticipated trial start date

2015

Year

03

Month

02

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(1)We will confirm that patients have HP infection at preoperative state.
(2)Prior to ESD, We will delineate early gastric cancer by magnifying endoscopy with narrow-band imaging (M-NBI).
(3)We will make markings on two points of the oral side and one point of the anal side on a non-cancerous mucosa within 5mm from the outside of the gastric cancerous extent.
(4)We will resect gastric cancer including all markings using ESD.
(5)A section for evaluation of the delineation will be cut along the line which includes either markings of the oral side and the anal side.
(6)We will judge the delineation by examing whether the three markings remain in a non-cancerous mucosa within 5mm from the gastric cancer border.
(7)We will perform surveillance after ESD through endoscopy semiannually for three years.

Registered date

2015

Year

03

Month

03

Day

Last modified on

2015

Year

03

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019364