UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029592 |
|---|---|
| Receipt number | R000029760 |
| Scientific Title | Assessmentment of the swallowing function of surgical cases of thoracic esophageal cancers with High Resolution Manometry System. |
| Date of disclosure of the study information | 2017/10/24 |
| Last modified on | 2022/10/21 13:05:49 |
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Basic information
Public title
Assessmentment of the swallowing function of surgical cases of thoracic esophageal cancers with High Resolution Manometry System.
Acronym
Assessmentment of the swallowing function of surgical cases of thoracic esophageal cancers with High Resolution Manometry System.
Scientific Title
Assessmentment of the swallowing function of surgical cases of thoracic esophageal cancers with High Resolution Manometry System.
Scientific Title:Acronym
Assessmentment of the swallowing function of surgical cases of thoracic esophageal cancers with High Resolution Manometry System.
Region
| Japan |
Condition
Condition
thoracic esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study is to analyze the swallowing function of surgical cases of thoracic esophageal cancers before and after surgery with High Resolution Manometry(HRM).
Basic objectives2
Others
Basic objectives -Others
We also evaluate the correlation between HRM data and the swallowing function on videofluorography.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the swallowing function with HRM before surgery, before discharge and 4months, 12 months after surgery.
The value of swalloing presure in pharynx and UES is analyzed.
Key secondary outcomes
To evaluate correlation between HRM data and the swallowing function on videofluorography.
The followings are analyzed on videofluorography.
Penetration Aspiration Scale
Laryngeal elevation delay time
Pharyngeal transit time
Residue of contrast medium in pharynx
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
50 surgical cases for thoracic esophageal cancers.
cases examined with HRM to evaluate swallowing function 4 times beore surgery, before discharge,4 months after surgery, and 12 months after surgery.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients planed to undergo esophagectomy for thoracic esophageal cancer
Patients with clinical stageI, II, or III on TNM classification(UICC-TNM 7th edition)
Patients with Performance Status 0 or 1(ECOG difinition)
Patients aged 20 to 85 years old on enrollment
Patients consented to paticipate in this study on document
Key exclusion criteria
Patients with active infection
Patients with severe heart disease
Patients with esophageal varices
Patients with past surgical history for esophageal or pharyngeal cancers except for endoscopic surgery
Patients with esophageal stenosis
Patients with severe mental or central nerve disorder
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kamei |
Organization
Tohoku University
Division name
Department of Surgery
Zip code
9808574
Address
Seiryo-machi 1-1, Aobaku, Sendai,JAPAN
TEL
022-717-7214
tkamei@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Koseki |
Organization
Tohoku University
Division name
Department of Surgery
Zip code
9808574
Address
Seiryo-machi 1-1, Aobaku, Sendai,JAPAN
TEL
022-717-7214
Homepage URL
kenko819@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduated school of medicine department of surgery
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduated school of medicine department of surgery
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
Tohoku University hospital ethics review committee
Address
Seiryo-machi 1-1, Aobaku, Sendai,JAPAN
Tel
022-717-7122
rinri-2@proj.med.tohoku.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
| 2017 | Year | 10 | Month | 24 | 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
| Delay expected |
Results Delay Reason
not fully analyzed yet
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 17 | Day |
Last modified on
| 2022 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029760
