UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046522 |
|---|---|
| Receipt number | R000052957 |
| Scientific Title | Efficacy and Safety of Multi Loop Traction Device-assisted Colorectal Endoscopic Submucosal Dissection: A Multicenter, Randomized Clinical Trial |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2022/06/07 15:06:45 |
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Basic information
Public title
Efficacy and Safety of Multi Loop Traction Device-assisted Colorectal Endoscopic Submucosal Dissection: A Multicenter, Randomized Clinical Trial
Acronym
Efficacy and Safety of Multi Loop Traction Device-assisted Colorectal Endoscopic Submucosal Dissection: A Multicenter, Randomized Clinical Trial
Scientific Title
Efficacy and Safety of Multi Loop Traction Device-assisted Colorectal Endoscopic Submucosal Dissection: A Multicenter, Randomized Clinical Trial
Scientific Title:Acronym
Efficacy and Safety of Multi Loop Traction Device-assisted Colorectal Endoscopic Submucosal Dissection: A Multicenter, Randomized Clinical Trial
Region
| Japan |
Condition
Condition
Colorectal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy and safety of multi loop traction device (MLTD) in colorectal endoscopic submucosal dissection (ESD)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dissection speed (area resected [mm^2]/duration in minutes)
Key secondary outcomes
1) Overall treatment duration (min)
2) Technical success (%)
3) En bloc resection rate (%)
4) R0 resection rate (%)
5) Intraoperative perforation rate (%)
6) Delayed perforation rate (%)
7) Delayed bleeding rate (%)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1) MLTD-ESD group
Colorectal endoscopic submucosal dissection (ESD) is performed using the Multi Loop Traction Device (MLTD). The number of MLTD used in a single session is not limited.
The conversion of the allocated therapeutic method is permitted. If the MLTD is ineffective for more than 10 minutes, the MLTD can be removed.
Interventions/Control_2
2) Conventional ESD group
ESD is completed using a standard therapeutic strategy that does not involve the use of traction devices.
The conversion of the allocated therapeutic method is permitted. The MLTD can be used if the endoscopist determines that the traction device has been required for more than 10 minutes.
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
Patients aged 20 years or older who undergo endoscopic submucosal dissection for superficial colorectal neoplasm with a tumor size of 20 mm or more
Key exclusion criteria
1) Patients who do not give consent for the study
2) Patients whose lesions involve terminal ileum, appendiceal orifice, or diverticulum
3) Patients with recurrent lesions at the scar after endoscopic treatment
4) Patients who are not managed according to guidelines regarding perioperative withdrawal of antithrombotic therapy
5) Patients with severe organ failure
6) Patients with coagulopathy at high risk of bleeding
7) Patients who are pregnant
8) Patients with urgent and obvious life threatening situation
9) Patients who are judged unsuitable for participation by the doctors
Target sample size
109
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Sumiyama |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
1058471
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL
0336331111
ms04furuhashi@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Furuhashi |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
1058471
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL
0336331111
Homepage URL
ms04furuhashi@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
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
The Jikei University School of Medicine
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
Tel
0336331111
rinri@jikei.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
| 2022 | Year | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2022 | Year | 01 | Month | 03 | Day |
Last modified on
| 2022 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052957
