UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010136 |
|---|---|
| Receipt number | R000010772 |
| Scientific Title | Prospective cohort study evaluating the long-term outcome after endoscopic submucosal dissection for colorectal neoplasia. |
| Date of disclosure of the study information | 2013/02/28 |
| Last modified on | 2025/09/05 09:51:08 |
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Basic information
Public title
Prospective cohort study evaluating the long-term outcome after endoscopic submucosal dissection for colorectal neoplasia.
Acronym
Long-term outcome after colorectal ESD.
Scientific Title
Prospective cohort study evaluating the long-term outcome after endoscopic submucosal dissection for colorectal neoplasia.
Scientific Title:Acronym
Long-term outcome after colorectal ESD.
Region
| Japan |
Condition
Condition
Colorectal neoplasia can be treated endoscopically
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the long-term outcome after ESD for colorectal neoplasia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
% 5-year survival without surgical resection in patients with pathological curative resection, % 5-year survival, proportion of one-piece resection, local recurrence, adverse effects
Key secondary outcomes
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
All patients who undergo colorectal ESD.
Key exclusion criteria
none
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Saito |
Organization
National cancer center hospital
Division name
Endoscopy
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuoku, Tokyo, Japan
TEL
03-3542-2511
ytsaito@ncc.go.jp
Public contact
Name of contact person
| 1st name | Nozomu |
| Middle name | |
| Last name | Kobayashi |
Organization
Tochigi cancer center
Division name
Diagnostic imaging
Zip code
320-0834
Address
4-9-13 Yonan, Utsunomiya, Tochigi, Japan
TEL
028-658-5151
Homepage URL
nkobayas@tcc.pref.tochigi.lg.jp
Sponsor or person
Institute
National cancer center hospital
Institute
Department
Personal name
Funding Source
Organization
National cancer center
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
Tochigi Cancer Center
Address
4-9-13 Yonan, Utsunomiya, Tochigi, Japan
Tel
028-658-5151
chiken@tcc.pref.tochigi.lg.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
| 2013 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35810779/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35810779/
Number of participants that the trial has enrolled
1883
Results
The 5-year overall survival rate was 93.6%, the disease-specific survival rate was 99.6%, and the intestinal preservation rate was 88.6%. No metastases were observed in cases classified as curative resection, whereas 4 cases of metastasis were confirmed in the non-curative resection group. The curative resection group showed significantly higher overall survival and disease-specific survival rates than the non-curative resection group (P < .001 and P = .009, respectively).
Results date posted
| 2025 | Year | 09 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 07 | Month | 08 | Day |
Baseline Characteristics
In the 1814 cases, the mean tumor diameter was 32.4 mm, and more than one-half of the lesions (55.5%) were located in the right colon. Regarding morphology, 1612 (88.9%) corresponded to LST.
Participant flow
From February 2013 to January 2015, ESD was performed on 1,883 patients with 1,965 lesions. Among these, 1,740 patients with 1,814 colorectal epithelial tumors measuring 20 mm or larger were included in the analysis.
Adverse events
Seven emergent surgeries were conducted to treat patients with delayed perforation.
Outcome measures
The primary endpoint, the 5-year overall survival rate for all cases, was 93.6%.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 10 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
All patients who undergo colorectal ESD are enrolled before treatment and will follow for 5 years, prospectivily.
Management information
Registered date
| 2013 | Year | 02 | Month | 28 | Day |
Last modified on
| 2025 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010772
