UMIN-CTR Clinical Trial

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

Thoracic esophageal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Graduate School of Medicine, Tohoku University

Institute

Department

Personal name

Organization

Graduate School of Medicine, Tohoku University, Digestive surgery

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

12

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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