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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029592
Receipt No. 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 2019/04/19

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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
Email 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
Email kenko819@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduated school of medicine department of surgery
Institute
Department

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
Email 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
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 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
2019 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029760

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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