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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027115
Receipt No. 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 2017/10/24

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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
Institute Fukui prefectural hospital
Institute
Department

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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 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
2017 Year 04 Month 24 Day
Last modified on
2017 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.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


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