UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044059 |
|---|---|
| Receipt number | R000050218 |
| Scientific Title | A prospective randomized trial comparing the pocket-creation method with clip traction and the pocket-creation method of colonic endoscopic submucosal dissection |
| Date of disclosure of the study information | 2021/04/28 |
| Last modified on | 2024/03/15 13:33:59 |
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Basic information
Public title
A prospective randomized trial comparing the pocket-creation method with clip traction and the pocket-creation method of colonic endoscopic submucosal dissection
Acronym
A prospective randomized trial comparing PCM-CT and PCM of colonic ESD
Scientific Title
A prospective randomized trial comparing the pocket-creation method with clip traction and the pocket-creation method of colonic endoscopic submucosal dissection
Scientific Title:Acronym
A prospective randomized trial comparing PCM-CT and PCM of colonic ESD
Region
| Japan |
Condition
Condition
Superficial colorectal neoplasms
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of PCM-CT compared PCM in colonic ESD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dissection speed and procedure time of ESD
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
ESD using PCM-CT
Interventions/Control_2
ESD using PCM
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Superficial colorectal neoplasms 20 mm - 100 mm in diameter
Key exclusion criteria
1)Patients with lesions extending into the appendix orifice
2)Patients with lesions extending into the diverticulum
3)Patients with lesions extending the ileocecal valve
4)Patients with ulcerative colitis, Crohn disease
5)Patients with sever organ failure
6)Patients with lesion length diameter less than 2 cm, giant lesions with lesion length diameter exceeding 10 cm
7)Patients with rectal (Ra, Rb) lesions
8)Minors (19 years old or younger), seniors 91 years old or older
9)Patients who have been judged as inappropriate for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Hayashi |
Organization
Jichi Medical University
Division name
Department of Medicine, Division of Gastroenterology
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi Japan
TEL
0285-58-7348
hayashi@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Morikawa |
Organization
Jichi Medical University
Division name
Department of Medicine, Division of Gastroenterology
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi Japan
TEL
0285-58-7348
Homepage URL
d2023@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
Jichi Medical University Clinical Research Ethics Committee
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
Tel
0285-58-7637
rinri@jichi.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
| 2021 | Year | 04 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-2276-0546
Number of participants that the trial has enrolled
100
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
| 2021 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2021 | Year | 04 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050218
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
