UMIN-CTR Clinical Trial

Basic information
Public title	Changes in pulmonary function tests and respiratory symptoms after airway stent removal
Acronym	Pulmonary function after airway stent removal
Scientific Title	Changes in pulmonary function tests and respiratory symptoms after airway stent removal
Scientific Title:Acronym	Pulmonary function after airway stent removal
Region	Japan

Condition
Condition	Airway stenotic diseases
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate changes in pulmonary function and respiratory symptoms after vs. before airway stent removal
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Changes in pulmonary function test results (peak expiratory flow) after vs. before airway stent removal
Key secondary outcomes	1. Changes in pulmonary function test results (FVC, FEV1) after airway stent removal 2. Changes in respiratory symptoms (frequency of coughing, amount of sputum, difficulty of expectoration, dyspnea) assessed by a visual analog scale after vs. before airway stent removal 3. Frequency of airway stent re-insertion 4. Incidence of adverse effects

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients with an airway stent who require stent removal because of a response to tumor-specific therapy or stent-related respiratory symptoms 2. 20 years old or older 3. Informed consent
Key exclusion criteria	1. Patients expected to need stent re-insertion in the same setting as stent removal 2. Patients with multiple stents expected to undergo the removal of only some of them 3. Patients who cannot perform pulmonary function testing (e.g., patients with a tracheostomy or who are on mechanical ventilation) 4. Patients who cannot assess their respiratory symptoms using a visual analog scale 5. Patients who require stent removal due to stent migration 6. Patients who require bronchoscopic procedures other than stent removal (e.g., ablation of tumor or granulation tissue) in the same setting
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masahide Oki
Organization	Nagoya Medical Center
Division name	Department of Respiratory Medicine
Zip code
Address	4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL	052-951-1111
Email	masahideo@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Masahide Oki
Organization	Nagoya Medical Center
Division name	Department of Respiratory Medicine
Zip code
Address	4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL	052-951-1111
Homepage URL
Email	masahideo@gmail.com

Sponsor
Institute	Nagoya Medical Center
Institute
Department

Funding Source
Organization	none
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
Address
Tel
Email

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	2016 Year 12 Month 07 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	Completed
Date of protocol fixation	2016 Year 11 Month 30 Day
Date of IRB	2016 Year 11 Month 30 Day
Anticipated trial start date	2016 Year 12 Month 07 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective consecutive study

Management information
Registered date	2016 Year 12 Month 06 Day
Last modified on	2021 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028950