| CTRI Number |
CTRI/2023/06/054451 [Registered on: 26/06/2023] Trial Registered Prospectively |
| Last Modified On: |
10/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
STUDY TO ASSESS CHANGES IN AIRWAYS AND LUNG PARENCHYMA IN COPD PATIENTS ON HRCT IMAGING.
|
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Scientific Title of Study
|
ASSESSMENT OF PARENCHYMAL AND AIRWAY CHANGES ON HRCT IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHASHANK SHEKHAR PANDEY |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KASTURBA MEDICAL COLLEGE , MADHAVNAGAR , UDUPI |
| Address |
DEPARTMENT OF RADIO-DIAGNOSIS AND IMAGING, KASTURBA MEDICAL COLLEGE , MADHAVANAGAR , UDUPI
Udupi
KARNATAKA
576104
India |
| Phone |
8808087308 |
| Fax |
|
| Email |
luphae@icloud.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRAJAGOPAL KV |
| Designation |
PROFESSOR |
| Affiliation |
KASTURBA MEDICAL COLLEGE , MADHAVNAGAR , UDUPI |
| Address |
DEPARTMENT OF RADIO-DIAGNOSIS AND IMAGING, KASTURBA MEDICAL COLLEGE , MADHAVANAGAR , UDUPI
Udupi
KARNATAKA
576104
India |
| Phone |
9448158901 |
| Fax |
|
| Email |
rajagopal.kv@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
SHASHANK SHEKHAR PANDEY |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KASTURBA MEDICAL COLLEGE , MADHAVNAGAR , UDUPI |
| Address |
DEPARTMENT OF RADIO-DIAGNOSIS AND IMAGING, KASTURBA MEDICAL COLLEGE , MADHAVANAGAR , UDUPI
Udupi
KARNATAKA
576104
India |
| Phone |
8808087308 |
| Fax |
|
| Email |
luphae@icloud.com |
|
|
Source of Monetary or Material Support
|
| Study done in Department of Radio-diagnosis , Kasturba medical college , Manipal . |
|
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Primary Sponsor
|
| Name |
Shashank Shekhar Pandey |
| Address |
Dept. of Radiodiagnosis and imaging , Kasturba Medical college , Manipal. |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shashank Shekhar Pandey |
Kasturba Medical College , Manipal. |
Department of Radiodiagnosis , Kasturba Medical college , Manipal
Udupi
KARNATAKA |
8808087308
luphae@icloud.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC2 : 604/2022 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J431||Panlobular emphysema, (2) ICD-10 Condition: J432||Centrilobular emphysema, (3) ICD-10 Condition: J438||Other emphysema, (4) ICD-10 Condition: J40||Bronchitis, not specified as acuteor chronic, (5) ICD-10 Condition: J42||Unspecified chronic bronchitis, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Clinical suspicion of COPD.
Spirometric abnormalities satisfying the GOLD criteria
Age >35 yrs.
|
|
| ExclusionCriteria |
| Details |
Previous surgical intervention on the lung .
Partial lung – post lobectomy/ pneumectomy / congenital disorders.
Lung tumors.
Severe lung disease other than COPD ( Pneumonia , Pleural effusion , Pulmonary edema). Metal grafts , endobronchial tubes , pacemakers.
Pregnancy.
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Morphometric and software-generated parameters like LAA and BWT can help us not only qualitatively estimate the predominant pattern of COPD in the patient but also help us quantify - percentage low attenuation areas to lung volume ratio would yield quantitative degree of parenchymal destruction by emphysematous changes of COPD at the time of study.Bronchial wall thickness would yield the affliction of airways as a marker of changes of chronic bronchitis component of COPD at the time of study. |
To be assessed at the end of study. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Qualitative estimation of the predominant pattern of COPD ( emphysematous vs Chronic Bronchitis ) in the study population , and help us sub-classify the predominant pattern of emphysematous changes.
Percentage expression of the predominant pattern of the COPD.
Percentage expression of the predominant type of the emphysematous changes . |
At the end of the study. |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
BACKGROUND -
COPD is typified by the occurrence of an airway obstruction, which is non-reversible on bronchodilator administration and occurs secondarily to airway narrowing, emphysema, or a combination of both .
The majority of cases , in clinical practice have varying components of both phenotypes. The purpose of this study is to prospectively quantifying both the components in patients of COPD. Variable degree of overlap between the two subtypes of COPD are seen in routinely. Using thin slice helical CT if quantitative and qualitative evaluation of COPD is done it will help quantify the extent of disease , decern and distinguish among the subtypes of COPD , assess the severity of the disease and help in prognostication.
Recent advances in software presets and imaging acquisitions aid not only in qualitative charecterisation of air-way and parenchymal disease but also quantify and grade its severity .
Separate 3D reconstruction of airway and parenchymal components from raw 1 mm sections with automated detection of airways and emphysematous areas help quantify the degree of airways and parenchymal affliction in COPD.
AIM -
The purpose of this study is to confirm and characterize COPD into its subtypes and quantify it’s severity using MDCT.
OBJECTIVES - •1. To assess the percentage of Low attenuation areas in the lung parenchyma to quantify emphysematous changes in the lung. •2. To assess the bronchial wall thickness of segmental and sub-segmental airways to detect and grade chronic bronchitis.
KNOWLEDGE GAP -
Spiro-metric analysis of the disease as per GOLD criteria fails to reflect –
1. Subtype predominance
2. Degree of airway and parenchymal affliction
Using thin slice helical CT if quantitative and qualitative evaluation of COPD is done it will help quantify the extent of disease , decern and distinguish among the subtypes of COPD , assess the severity of the disease and help in prognostication. JUSTIFICATION OF THE STUDY -
•COPD is a disease with significant morbidity and mortality . •Variable degree of overlap between the two subtypes of COPD are seen in routinely. |