UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052397 |
|---|---|
| Receipt number | R000059653 |
| Scientific Title | Efficacy and safety of a novel needle-type knife with through the needle fluid injection compared to a conventional needle-type knife for colorectal ESD |
| Date of disclosure of the study information | 2023/10/04 |
| Last modified on | 2025/04/04 11:09:31 |
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Basic information
Public title
Efficacy and safety of a novel needle-type knife with through the needle fluid injection compared to a conventional needle-type knife for colorectal ESD
Acronym
Efficacy and Safety of the Tech Knife for Colorectal ESD
Scientific Title
Efficacy and safety of a novel needle-type knife with through the needle fluid injection compared to a conventional needle-type knife for colorectal ESD
Scientific Title:Acronym
Efficacy and Safety of the Tech Knife for Colorectal ESD
Region
| Japan |
Condition
Condition
Colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the tech knife in colorectal ESD compared with a conventional needle-type knife, dual knife J.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resection time
Key secondary outcomes
Resection speed
Number of times the device is inserted and removed
Total local injection volume (volume of sodium hyaluronate solution and saline combined)
Intraoperative perforation 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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Group A: Tech knife group
Group A performs ESD using a Tech knife.
Interventions/Control_2
Group B: Dual knife J group
Group B performs ESD using a Dual knife.
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) Patients undergoing endoscopic submucosal dissection (ESD) for colorectal tumor.
2) Patients have been diagnosed with colorectal adenoma or early stage colorectal cancer (including suspected cancer) with suspected submucosal slight invasion larger than 20 mm.
3) Patients are more than 20 years old at the time of registration.
2) PS (ECOG) is either 0 or 1.
3) Written consent has been obtained after sufficient informed consent for participation in this study.
Key exclusion criteria
1) Giant lesions with a tumor diameter of 50 mm or more or more than 3/4 circumference
2) Extension into or proximity to the appendiceal orifice or diverticulum, requiring ESD treatment of the orifice or diverticular area
3) Local recurrence after endoscopic resection or postoperative anastomotic lesions
4) Colorectal cancer with inflammatory bowel disease
5) Familial adenomatous colorectal adenomatosis
6) Patients with infectious diseases requiring systemic treatment
7) Patients with serious comorbidities that make it difficult for them to participate in this study
8) Women of childbearing potential, pregnant, or lactating women
9) Positive COVID19 antigen test or PCR test, etc. in advance. No symptoms are required.
10) Other cases in which participation in this study is deemed inappropriate by the physician in charge
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Ohata |
Organization
NTT medical center Tokyo
Division name
Department of Gastrointestinal Endoscopy
Zip code
141-0022
Address
5 Chome-9-22 Higashigotanda, Shinagawa City, Tokyo
TEL
03-3448-6111
ken.ohata1974@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kano |
Organization
NTT medical center Tokyo
Division name
Department of Gastrointestinal Endoscopy
Zip code
141-0022
Address
5 Chome-9-22 Higashigotanda, Shinagawa City, Tokyo
TEL
03-3448-6111
Homepage URL
snowsmile19870628@gmail.com
Sponsor or person
Institute
NTT medical center Tokyo
Institute
Department
Personal name
Yuki Kano
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
NTT medical center Tokyo Ethics Committee
Address
5 Chome-9-22 Higashigotanda, Shinagawa City, Tokyo
Tel
0334486111
snowsmile19870628@gmail.com
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
NTT東日本関東病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 04 | 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
| 2023 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059653
