UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015743 |
|---|---|
| Receipt number | R000018319 |
| Scientific Title | Influence of esophageal endoscopic submucosal dissection on esophageal motility |
| Date of disclosure of the study information | 2014/11/23 |
| Last modified on | 2014/11/23 16:01:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Influence of esophageal endoscopic submucosal dissection on esophageal motility
Acronym
Esophageal motility after ESD
Scientific Title
Influence of esophageal endoscopic submucosal dissection on esophageal motility
Scientific Title:Acronym
Esophageal motility after ESD
Region
| Japan |
Condition
Condition
superficial esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the influence of ESD on esophageal peristaltic movement
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Esophageal peristaltic movement before and after ESD
Key secondary outcomes
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Esophageal manometry before and after ESD for esophageal cancer
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)histologically diagnosis of squamous cell carcinoma
2)sm2 or less than sm2 on clinical preoperative diagnosis
3)no lymph node or distant metastasis
4)written informed consent
5)0-2 on performance status
6)no severe organ dysfunction
Key exclusion criteria
1)poorly controlled DM
2)poorly controlled heart disease
3)active infection
4)current pregnancy
5)mental disorder
6)alcoholic or viral LC
7)history of surgical resection of Head and Neck or Esophagus
8)history of radiation for Head and Neck or Esophagus
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuru Kaise |
Organization
Toranomon Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-2-2 toranomon Minato-ku Tokyo
TEL
03-3588-1111
kaise@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiro Iizuka |
Organization
Toranomon Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-2-2 toranomon Minato-ku Tokyo
TEL
03-3588-1111
Homepage URL
t-iizuka@toranomon.gr.jp
Sponsor or person
Institute
Department of Gastroenterology, Toranomon Hospital
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
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
| 2014 | Year | 11 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 23 | Day |
Last modified on
| 2014 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018319
