UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037922 |
|---|---|
| Receipt number | R000043224 |
| Scientific Title | A pilot study of the Effect of Perioperative Inhaled Tiotropium for patients with chronic Obstructive Pulmonary disease in Esophageal cancer surgery |
| Date of disclosure of the study information | 2019/09/04 |
| Last modified on | 2024/10/21 16:28:49 |
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Basic information
Public title
A pilot study of the Effect of Perioperative Inhaled Tiotropium for patients with chronic Obstructive Pulmonary disease in Esophageal cancer surgery
Acronym
EPITOPE study
Scientific Title
A pilot study of the Effect of Perioperative Inhaled Tiotropium for patients with chronic Obstructive Pulmonary disease in Esophageal cancer surgery
Scientific Title:Acronym
EPITOPE study
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aim to assess the effect of perioperative inhaled tiotropium for patients with chronic obstructive pulmonary disease in esophageal cancer surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of pneumonia within 30 days after esophagectomy
Key secondary outcomes
1) Incidence of cardiovascular complications within 30 days after esophagectomy
2) Incidence of any postoperative complications within 30 days after esophagectomy
3) FEV1% (pretreatment, preoperative, postoperative)
4) Walking distances in incremental shuttle walking test (pretreatment, preoperative, postoperative)
5) Incidence of adverse events
6) Mortality within 30 days after esophagectomy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Inhalation of tiotropium of 5 microgram, starting from 2 weeks before esophagectomy.
Interventions/Control_2
No inhalation of tiotropium.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed esophageal cancer.
2) Resectable disease in preoperative evaluation.
3) Age of 20 years or older.
4) ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0-1.
5) Esophagectomy with thoracic procedure
6) Postbronchodilator FEV1/FVC (forced expiratory volume in 1s/forced vital capacity) < 0.70 assessed by spirometry.
7) Patients stopping smoking for two weeks or more.
8) Capable of inhalation.
9) Adequate organ function tolerable for the general anesthesia.
10) Written informed consent to participate.
Key exclusion criteria
1) Comorbidities
a) Previous history of thoracic surgery.
b) Patients with glaucoma.
c) Patients with prostatic hypertrophy.
d) Patients with heart failure and/or atrial fibrillation.
e) Previously treatment for chronic obstructive pulmonary disease (COPD) or bronchial asthma.
f) Patients with active infection.
2) Total pharyngolaryngoesophagectomy, two staged esophagectomy, and reconstruction without gastric conduit.
3) Others
a) Patients with psychiatric disease.
b) Patients who were judged inappropriate to entry this study by physician in charge.
c) Previous history of hypersensitivity to atropine or drugs similar to atropine.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Watanabe |
Organization
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Division of Esophageal Surgery, Department of Gastroenterological Surgery
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL
03-3520-0111
masayuki.watanabe@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Okamura |
Organization
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Division of Esophageal Surgery, Department of Gastroenterological Surgery
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL
03-3520-0111
Homepage URL
https://jfcr.bvits.com/rinri/Apply/project.aspx?PROJECT_ID=775
akihiko.okamura@jfcr.or.jp
Sponsor or person
Institute
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
2019 JATS (Japanese Association for Thoracic Surgery) award for young investigators
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Japanese Foundation for Cancer Research
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
Tel
03-3520-0111
med.shinsa@jfcr.or.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
| 2019 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
https://karger.com/esr/article-abstract/61/4-5/123/128590/The-Design-of-and-Rationale-for-the-Effect
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s11748-024-02083-1
Number of participants that the trial has enrolled
32
Results
Preoperative tiotropium inhalation significantly improved pulmonary function and exercise tolerance in patients with COPD undergoing esophagectomy. The perioperative tiotropium did not reduce pneumonia after esophagectomy, but it may contribute to patient recovery by reducing postoperative pulmonary function deterioration.
Results date posted
| 2024 | Year | 10 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 09 | Month | 18 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 27 | Day |
Date of closure to data entry
| 2024 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 04 | Day |
Last modified on
| 2024 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043224
