UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029760