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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032896
Receipt No. R000037506
Scientific Title Exploratory prospective observation study of the association with preoperative plasma substance P concentration and subclinical cerebral infarction and postoperative swallowing dysfunction in patients with thoracic esophageal cancer.
Date of disclosure of the study information 2020/03/31
Last modified on 2020/12/07

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Basic information
Public title Exploratory prospective observation study of the association with preoperative plasma substance P concentration and subclinical cerebral infarction and postoperative swallowing dysfunction in patients with thoracic esophageal cancer.
Acronym The association with plasma substance P concentration and subclinical cerebral infarction and aspiration
Scientific Title Exploratory prospective observation study of the association with preoperative plasma substance P concentration and subclinical cerebral infarction and postoperative swallowing dysfunction in patients with thoracic esophageal cancer.
Scientific Title:Acronym The association with plasma substance P concentration and subclinical cerebral infarction and aspiration
Region
Japan

Condition
Condition patients with histologically proved primary thoracic esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Substance P (SP) is a transmitter to be produced by stimulation of dopamine produced in the basal ganglion, to be secreted from the nerve termination of the glosspharyngeal nerve and vagus nerve to the pharynx and to regulate the swallowing reflex. It has been reported that patients with stroke have a high risk of aspiration pneumonia, which has a close relationship to the decrease of SP concentration in the plasma or the sputum. However, there is no evidence of the association with low plasma SP concentration and subclinical infarction adjacent to the basal ganglion. On the other hand, postoperative aspiration pneumonia is one of severe complications with fatal possibility after esophagectomy for esophageal cancer. The improvement of surgical procedure and perioperative management cannot still prevent development of postoperative aspiration pneumonia completely. We speculate such patients who develop aspiration pneumonia despite various kind of measures might have low plasma SP concentration preoperatively and also have subclinical cerebral infarction. Then, to elucidate the validity of our speculations, we first investigate the association with preoperative low plasma SP concentration and subclinical cerebral infarction adjacent to the basal ganglion.
Basic objectives2 Others
Basic objectives -Others Next, we plan to examine whether preoperative low plasma SP concentration has a close association with postoperative swallowing dysfunction or not and whether it is sensitive for detection of patients with high risk of postoperative aspiration preoperatively or not.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The association with preoperative plasma substance P concentration and the presence or absence of subclinical cerebral infarction adjacent to the basal ganglion
Key secondary outcomes 1. the association with preoperative plasma substance P concentration and preoperative swallowing function.
2. the association with location of subclinical cerebral infarction and preoperative swallowing function
3.the association with preoperative substance P concentration and postoperative swallowing function
4. the association with preoperative subclinical cerebral infarction and postoperative swallowing function
5. plasma substance P concentration at the time of developing aspiration

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. histologically proved primary esophageal thoracic cancer
2. any kind of histological type
3. to undergo medical tretament
4. good general condition
5. any kind of treatment modality
6. any kind of surgical procedure in surgical case
7. gastroesophageal junctional tumor resected through right thoracotomy
8. any curativity
9. preoperative therapy does not matter.
11. 20 years or older
12. Informed consent was obtained in a document.
Key exclusion criteria 1. neck or abdominal esophageal cancer
2. hoarseness
3. recurrent esophageal cancer
4. gastroesophageal junctional tumor resected without right thoracotomy
5. giant lymph node metastasis in the neck
6. synchronous head and neck cancer
7. past history of surgery for head and neck cancer
8. past history of irradiation for head and neck cancer
9. cormorbidity with swallowing dysfunction
10. no indication for MRI
11. claustrophobia
12. severe mental disorder
13. judgement by attending doctor
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Takushi
Middle name
Last name Yasuda
Organization Kindai University Faculty of Medicine
Division name Division of esophago-gastric surgery, Department of Surgery
Zip code 589-8511
Address 377-2, Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan
TEL 072-366-0221
Email takushi-yasuda6008@med.kindai.ac.jp

Public contact
Name of contact person
1st name Takush
Middle name
Last name Yasuda
Organization Kindai University Faculty of Medicine
Division name Division of esophago-gastric surgery, Department of Surgery
Zip code 589-8511
Address 377-2, Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan
TEL 072-366-0221
Homepage URL
Email takushi-yasuda6008@med.kindai.ac.jp

Sponsor
Institute Department of Surgery,
Kindai University Faculty of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee
Address 377-2, Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan
Tel 072-366-0221
Email zizen@med.kindai.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 近畿大学病院(大阪府)

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 31 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 Open public recruiting
Date of protocol fixation
2017 Year 02 Month 22 Day
Date of IRB
2017 Year 03 Month 27 Day
Anticipated trial start date
2018 Year 06 Month 06 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The enrolled patients provide blood sample for measuring the concentration of plasma substance P (SP) and undergo the examination of brain MRI and the evaluation of swallowing function by videofluorography (VF) by doctor belonging to the rehabilitation unit and by videoendoscopy (VE) by otolaryngologist preoperatively. Then, before starting a meal after operation, the evaluation of postoperative swallowing function by VF and VE are conducted. If patient developed aspiration or aspiration pneumonia, the collection of blood sample for measuring plasma SP concentration and the swallowing evaluation by VE if possible is planed to be carried out.

Management information
Registered date
2018 Year 06 Month 06 Day
Last modified on
2020 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037506

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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