UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056611 |
|---|---|
| Receipt number | R000064696 |
| Scientific Title | A randomised controlled trial of the efficacy and safety of the Multi Loop Traction Device (MLTD) compared with the clip-with-line traction method in endoscopic submucosal dissection (ESD) for gastric neoplasia. |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2025/12/31 12:03:27 |
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Basic information
Public title
A randomised controlled trial of the efficacy and safety of the Multi Loop Traction Device (MLTD) compared with the clip-with-line traction method in endoscopic submucosal dissection (ESD) for gastric neoplasia.
Acronym
MLTD trial2
Scientific Title
A randomised controlled trial of the efficacy and safety of the Multi Loop Traction Device (MLTD) compared with the clip-with-line traction method in endoscopic submucosal dissection (ESD) for gastric neoplasia.
Scientific Title:Acronym
MLTD trial2
Region
| Japan |
Condition
Condition
gastric neoplasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the MLTD traction method for ESD in gastric neoplasia compared with the conventional clip-with-line traction method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dissection speed in ESD
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
Traction with MLTD
Interventions/Control_2
Traction with clip-with-line
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. 18 years of age or older
2. Early-stage gastric cancer or gastric adenoma that is an absolute indication, an expanded indication, or a relative indication as an alternative treatment according to the 6th edition of the Gastric Cancer Treatment Guidelines, and in which the tumor is located in the upper third or middle third of the stomach (U or M region in the 15th edition of the Japanese Gastric Cancer Association's "Gastric Cancer Treatment Guidelines").
3. Cases in which the patient has given written informed consent after fully understanding the subject of the study.
Key exclusion criteria
1. Cases of post-gastrectomy
2. Cases where consent for this study cannot be obtained
3. Cases with active infection, pregnancy or breastfeeding, serious mental illness, on steroid treatment, within 6 months of myocardial infarction, angina within 3 weeks, serious lung disease requiring oxygen inhalation, poorly controlled hypertension or diabetes.
4. Other cases deemed inappropriate by the investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Chika |
| Middle name | |
| Last name | Kusano |
Organization
Department of Gastroenterology, Kitasato University School of Medicine
Division name
Department of Gastroenterology, Kitasato University School of Medicine
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan.
TEL
042-778-8111
genkit@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Gen |
| Middle name | |
| Last name | Kitahara |
Organization
Department of Gastroenterology, Kitasato University School of Medicine
Division name
Department of Gastroenterology, Kitasato University School of Medicine
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan.
TEL
042-778-8111
Homepage URL
genkit@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato university hospital Clinical Research Ethics Committee
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan.
Tel
042-778-8111
rinri@med.kitasato-u.ac.jp
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
| 2025 | Year | 01 | 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
| 2024 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 31 | Day |
Last modified on
| 2025 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064696
