UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035216 |
|---|---|
| Receipt number | 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 | 2019/10/28 19:47:31 |
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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 | 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
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
tkamei@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039462
