UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038042 |
|---|---|
| Receipt number | R000043287 |
| Scientific Title | Optimal Selection of Endoscopic Resection in Patients with Esophageal Squamous Cell Carcinoma: Endoscopic Mucosal Resection vs Endoscopic Submucosal Dissection According to Lesion Size |
| Date of disclosure of the study information | 2019/09/18 |
| Last modified on | 2019/09/18 18:21:38 |
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Basic information
Public title
Optimal Selection of Endoscopic Resection in Patients with Esophageal Squamous Cell Carcinoma: Endoscopic Mucosal Resection vs Endoscopic Submucosal Dissection According to Lesion Size
Acronym
Optimal Selection of Endoscopic Resection in Patients with Esophageal Squamous Cell Carcinoma According to Lesion Size
Scientific Title
Optimal Selection of Endoscopic Resection in Patients with Esophageal Squamous Cell Carcinoma: Endoscopic Mucosal Resection vs Endoscopic Submucosal Dissection According to Lesion Size
Scientific Title:Acronym
Optimal Selection of Endoscopic Resection in Patients with Esophageal Squamous Cell Carcinoma According to Lesion Size
Region
| Japan |
Condition
Condition
esophageal superficial cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
therapeutic methods of endoscopic resection are not currently standardized for SESCC lesions 20 mm or less in size. This retrospective study aimed to clarify optimal treatment selection of endoscopic resection according to lesion size.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The short- and long- term outcomes were investigated for each EMR and ESD groups.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among a total of 760 patients with 858 lesions who presented between January 2011 and December 2015, 196 single new lesions with 20 mm or less in size determined to be M or cT1b-SM were enrolled.
Key exclusion criteria
Exclusion criteria included patients with follow up periods of less than 1 year and patients that received additional therapy post-resection (i.e. chemoradiotherapy and additional surgery)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Seiichiro |
| Middle name | |
| Last name | Abe |
Organization
National Cancer Center Hospital
Division name
Endoscopy
Zip code
104-0045
Address
5-1-1 Tukiji Tyuuouku Tokyo
TEL
03-3542-2511
seabe@ncc.go.jp
Public contact
Name of contact person
| 1st name | Kazumasa |
| Middle name | |
| Last name | Kawashima |
Organization
National Cancer Center Hospital
Division name
Endoscopy
Zip code
104-0045
Address
5-1-1 Tukiji Tyuuouku Tokyo
TEL
03-3542-2511
Homepage URL
kazkawas@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JPN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital
Address
5-1-1 Tukiji Tyuuouku Tokyo
Tel
0335422511
kazkawas@ncc.go.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
| 2019 | Year | 09 | Month | 18 | 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
760
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
| 2011 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Among a total of 760 patients with 858 lesions who presented between January 2011 and December 2015, 196 single new lesions with 20 mm or less in size determined to be M or cT1b-SM were enrolled. Patients were classified into one of 3 groups: lesions with 10 mm or less in size (group A), lesions with 11-15mm (group B), lesions with 16-20mm (group C). We assessed en block and curative resection rate, procedure time, complications and recurrence rates.
Management information
Registered date
| 2019 | Year | 09 | Month | 18 | Day |
Last modified on
| 2019 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043287
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
