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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035216
Receipt No. R000039462
Scientific Title A study for laryngopharyngeal reflux after thoracic esophageal cancer surgery using multichannel intraluminal impedance and pH monitoring
Date of disclosure of the study information 2018/12/11
Last modified on 2018/12/11

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Basic information
Public title A study for laryngopharyngeal reflux after thoracic esophageal cancer surgery using multichannel intraluminal impedance and pH monitoring
Acronym A study for laryngopharyngeal reflux after thoracic esophageal cancer surgery
Scientific Title A study for laryngopharyngeal reflux after thoracic esophageal cancer surgery using multichannel intraluminal impedance and pH monitoring
Scientific Title:Acronym A study for laryngopharyngeal reflux after thoracic esophageal cancer surgery
Region
Japan

Condition
Condition Thoracic esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 For thoracic esophageal cancer, a 24-hour multi-impedance-pH monitoring is performed before and after surgery in a case where surgery is performed, and changes in the throat head reflux before and after surgery are analyzed. We examine the relationship between LPR and subjective symptoms and endoscopic findings.
Basic objectives2 Others
Basic objectives -Others Prospective observational study before and after surgery
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Result of 24-hour multi impedance-pH monitoring.And the relationship between questionnaire of symptoms, endoscopic examination findings and the results.
Key secondary outcomes We analyze the correlation between MII / pH monitoring analysis results, respiratory function test, and blood test changes in serum Alb value and body weight before and after surgery, and study correlation.
We will also pick up cases of pneumonia that occurred in the first year after surgery and examine MII / pH monitoring results in those cases.

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 Patients who undergo esophageal resection for thoracic esophageal cancer are included. In addition to ordinary medical examination, examination for 24-hour multi-impedance / pH monitoring and questionnaire survey on reflux symptoms are added before surgery and 1 week 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 (1) Surgery (esophageal resection, reconstruction) is scheduled to be performed for thoracic esophageal cancer.
(2) Clinical stage cStage I, II, III in TNM classification (UICC-TNM 7th edition).
(3) Performance Status is 0 to 1 on the basis of ECOG.
(4) The age at registration is over 20 years old and under 85 years old.
(5) Participation in research Documents consent has been obtained from the patient himself.
Key exclusion criteria (1) Have active infectious disease.
(2) Have heart disease accompanied by symptoms.
(3) Oral ingestion is impossible due to impaired passage of the esophagus.
(4) There is a history of psychiatric disorder or central nervous disorder that has not been controlled.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kamei
Organization Graduate School of Medicine, Tohoku University
Division name Digestive surgery
Zip code
Address 1-1 Seiryocho Aoba-ku, Sendai-shi, 980-8574
TEL 022-717-7214
Email tkamei@surg.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kamei
Organization Graduate School of Medicine, Tohoku University
Division name Digestive surgery
Zip code
Address 1-1 Seiryocho Aoba-ku, Sendai-shi, 980-8574
TEL 022-717-7214
Homepage URL
Email tkamei@surg.med.tohoku.ac.jp

Sponsor
Institute Graduate School of Medicine, Tohoku University
Institute
Department

Funding Source
Organization Graduate School of Medicine, Tohoku University, Digestive 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
Address
Tel
Email

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 12 Month 11 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 11 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
2018 Year 12 Month 11 Day
Last modified on
2018 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039462

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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