UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032615 |
|---|---|
| Receipt number | R000037192 |
| Scientific Title | A prospective interventional study evaluating the safety and efficacy of trans-nasal hybrid endoscopic submucosal dissection for the treatment of early gastric cancer |
| Date of disclosure of the study information | 2018/05/16 |
| Last modified on | 2026/02/20 17:26:40 |
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Basic information
Public title
A prospective interventional study evaluating the safety and efficacy of trans-nasal hybrid endoscopic submucosal dissection for the treatment of early gastric cancer
Acronym
Efficacy of trans-nasal hybrid ESD for the treatment of early gastric cancer
Scientific Title
A prospective interventional study evaluating the safety and efficacy of trans-nasal hybrid endoscopic submucosal dissection for the treatment of early gastric cancer
Scientific Title:Acronym
Efficacy of trans-nasal hybrid ESD for the treatment of early gastric cancer
Region
| Japan |
Condition
Condition
early gastric cancer/adenoma
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of trans-nasal hybrid ESD for the treatment of early gastric cancer, a prospective interventional study
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rare/R0 resection rate
Key secondary outcomes
Procedure time, complication rate (perforation, delayed-bleeding), face scale, Vital signs (BP, HR, SpO2)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
ESD for gastric neoplasms
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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with 20mm or less early gastric cancer/adenoma over 80 years old
Key exclusion criteria
1. Hb < 9 g/dl
2. Pregnant women
3. Patients with severe heart/kidney/liver diseases
4. Patients in disagreement with informed consent
5. Others
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Sakai |
Organization
NTT Medical Center Tokyo
Division name
Gastroenterology
Zip code
141-8625
Address
5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL
03-3448-6111
eiji525@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Sakai |
Organization
NTT Medical Center Tokyo
Division name
Gastroenterology
Zip code
141-8625
Address
5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL
03-3448-6111
Homepage URL
eiji525@yokohama-cu.ac.jp
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Funding Source
Organization
NTT Medical Center Tokyo
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
Address
5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
Tel
03-3448-6111
eiji525@yokohama-cu.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
| 2018 | Year | 05 | Month | 16 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2025 | 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
| 2018 | Year | 05 | Month | 16 | Day |
Last modified on
| 2026 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037192
