UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027115
Receipt number R000031071
Scientific Title A randomized controlled trial to assess the effectiveness of clip and snare method using pre-looping technique(CSM-PLT) for gastric endoscopic submucosal dissection
Date of disclosure of the study information 2017/07/01
Last modified on 2022/01/15 15:16:29

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Basic information

Public title

A randomized controlled trial to assess the effectiveness of clip and snare method using pre-looping technique(CSM-PLT) for gastric endoscopic submucosal dissection

Acronym

CSM-PLT trial

Scientific Title

A randomized controlled trial to assess the effectiveness of clip and snare method using pre-looping technique(CSM-PLT) for gastric endoscopic submucosal dissection

Scientific Title:Acronym

CSM-PLT trial

Region

Japan


Condition

Condition

gastric adenoma or early gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of ESD using CSM-PLT compared with conventional ESD in terms of procedure time for patients with gastric epithelial neoplasia

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

ESD procedure time

Key secondary outcomes

ESD procedure time according to
/1. the endoscopist experience(expert or non-expert)
/2. the location of the lesion
/3. size of the lesion
/4. presence of ulceration
/5. incision device
6. procedure time for submucosal dissection of the lesion
7. successful procedure rate of ESD non-expert
8. coagulation procedure, number of times, duration
9. en bloc resection rate
10. adverse events rate


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

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

A: Conventional ESD group

Interventions/Control_2

B: ESD using CSM-PLT group

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. Histologically proven gastric adenoma or cancer
2. early gastric cancer which is within the absolute or expanded indication of ESD according to Japanese gastric cancer treatment guideline(ver4)
3. With only one lesion which will be treated endoscopically
4. Aged 20 years old or over
5. PS(ECOG)0.1.2
6. Meet all of the following criteria without blood transfusion in the past 14 days
a.Hb >= 9g/dl
b.Plt>= 100,000/mm3
c.AST,ALT <= 100
d.Cr <= 2.0mg/dl
7. Patients with written informed consent of this study

Key exclusion criteria

1. Patient with registration history of this study
2. Patient who are pregnant, may be pregnant, or lactating woman
3. Patient with psychosis

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenkei Hasatani , MD

Organization

Fukui Prefectural Hospital

Division name

Department of Gastroenterology

Zip code


Address

2-8-1Yotsui , Fukuii city, Fukui, 910-8526, Japan

TEL

0776-54-5151

Email

hasatani9@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naohiro Yoshida, MD

Organization

Ishikawa Prefectural Central Hospital

Division name

Department of Gastroenterology

Zip code


Address

2-1 Kuratukihigashi Kanazawa, Ishikawa, 920-8530, Japan

TEL

076-237-8211

Homepage URL


Email

ynaohiro@ipch.jp


Sponsor or person

Institute

Fukui prefectural hospital

Institute

Department

Personal name



Funding Source

Organization

Fukui prefectural hospital

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

2017 Year 07 Month 01 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

2017 Year 03 Month 08 Day

Date of IRB

2017 Year 03 Month 08 Day

Anticipated trial start date

2017 Year 07 Month 01 Day

Last follow-up date

2020 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

2017 Year 04 Month 24 Day

Last modified on

2022 Year 01 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031071


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name