UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004040 |
|---|---|
| Receipt number | R000004868 |
| Scientific Title | Prospective cohort study to evaluate the efficacy and safety of endoscopic submucosal dissection for colorectal tumor |
| Date of disclosure of the study information | 2010/08/14 |
| Last modified on | 2024/08/28 11:12:36 |
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Basic information
Public title
Prospective cohort study to evaluate the efficacy and safety of endoscopic submucosal dissection for colorectal tumor
Acronym
Prospective cohort study to evaluate the efficacy and safety of ESD for colorectal tumor
Scientific Title
Prospective cohort study to evaluate the efficacy and safety of endoscopic submucosal dissection for colorectal tumor
Scientific Title:Acronym
Prospective cohort study to evaluate the efficacy and safety of ESD for colorectal tumor
Region
| Japan |
Condition
Condition
colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of ESD for colorectal tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of complete en bloc resection and complication in colorectal ESD
Key secondary outcomes
Prevalence of local/residual recurrence after ESD
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Colorectal ESD cases
Early colorectal cancer (larger than 20 mm in diameter) for which endoscopic treatment is indicative but for which en bloc resection by snare EMR would be difficult.
Adenoma with non-lifting sign (+) after injection during EMR procedures.
Local residual tumor after EMR (larger than 10 mm in diameter) for which en bloc resection by snare EMR would be difficult.
Key exclusion criteria
Excluding the sentences above
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Kaminishi |
Organization
Japan Gastroenterological Endoscopy Society (JGES)
Division name
President
Zip code
Address
3-22 Kanda Ogawamachi, Chiyoda-ku, Tokyo, Japan
TEL
03-3291-4111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Ishikawa |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular-Targeting Cancer Prevention
Zip code
Address
3-1-2F Kyomachibori Nishi-ku 2-chome Osaka 550-0003, Japan
TEL
06-6445-5585
Homepage URL
cancer@gol.com
Sponsor or person
Institute
Japan Gastroenterological Endoscopy Society (JGES)
Institute
Department
Personal name
Funding Source
Organization
Japan Gastroenterological Endoscopy Society (JGES)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 08 | Month | 14 | Day |
Related information
URL releasing protocol
https://jpn01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.jstage.jst.go.jp%2Farticle%2Fg
Publication of results
Unpublished
Result
URL related to results and publications
https://jpn01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.jstage.jst.go.jp%2Farticle%2Fg
Number of participants that the trial has enrolled
1564
Results
ESD was completed without interception in 1544 (98.7%) patients. Intraoperative bleeding, postoperative bleeding, intraoperative perforation, postoperative perforation, penetration, and peritonitis occurred in 19(1.2%), 43 (2.8%), 47 (3.0%), 6 (0.4%), 19 (1.2%), and 8 (0.5%) patients, respectively. Emergency surgical rescue was necessary in 8 (0.5%) patients(4 for intraoperative perforation, 4 for postoperative perforation).
Results date posted
| 2024 | Year | 03 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2015 | Year | 06 | Month | 01 | Day |
Baseline Characteristics
This nationwide registry aimed to accumulate more than 1000 consecutive patients with colorectal ESD throughout Japan from August 2010 to January 2012 for data analysis with sufficient power. Before starting this registry, the organizing committee for investigation of colorectal ESD in JGES was formulated.
Participant flow
This nationwide registry collected 1564 patients with colorectal ESD at 69 hospitals in Japan from August 2010 to January 2012. Clnicopathological characteristics are shown in Table 1. Mean tumor size was 32.5 mm (range, 4-100 mm) and 984 (62.9%) lesions were finally diagnosed as carcinoma after ESD.
Adverse events
Intraoperative bleeding, postoperative bleeding, intraoperative perforation, postoperative perforation, penetration, and peritonitis occurred in 19 (1.2%), 43 (2.8%), 47 (3.0%), 6 (0.4%), 19 (1.2%), and 8 (0.5%) patients, respectively. Emergency surgical rescue was necessary in 8 (0.5%) patients (4 for intraoperative perforation, 4 for postoperative perforation). Transfusion was performed in one patient (0.06%) due to postoperative bleeding. Follow up in one year revealed a rate of local recurrence was
0.90%(11/1217).
Outcome measures
Treatment outcomes, especially rates of en bloc resection, en bloc plus R0 (tumor-free margins) resection and ESD related complications were investigated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2010 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study
Management information
Registered date
| 2010 | Year | 08 | Month | 14 | Day |
Last modified on
| 2024 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004868
