UMIN-CTR Clinical Trial

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 Takashi Middle name Last name Kamei
Organization	Graduate School of Medicine, Tohoku University
Division name	Digestive surgery
Zip code	980-8574
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 Takashi Middle name Last name Kamei
Organization	Graduate School of Medicine, Tohoku University
Division name	Digestive surgery
Zip code	980-8574
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	Ethics Committee, Tohoku University Graduate School of Medicine
Address	2-1 Seiryocho Aoba-ku, Sendai-shi
Tel	022-728-4105
Email	hosp-ken@grp.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	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	Enrolling by invitation
Date of protocol fixation	2018 Year 12 Month 11 Day
Date of IRB	2019 Year 01 Month 23 Day
Anticipated trial start date	2019 Year 01 Month 23 Day
Last follow-up date	2024 Year 01 Month 23 Day
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	2019 Year 10 Month 28 Day

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