Endobronchial GrowthNCT00963716
Hot and Cold Biopsy Forceps in the Diagnosis of Endobronchial Lesions
A study testing Hot biopsy forceps and Cold biopsy forceps in people with Endobronchial Growth and Lung Cancer, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
A new electrocautery bronchoscopy biopsy forceps is now commercially available and may prevent bleeding following biopsy. Only one study used this device wherein the authors concluded that the use of hot biopsy forceps for endobronchial biopsy does not appear to have a negative impact on the pathological samples, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endobronchial Growth, Lung Cancer
- What is being tested?
- Hot biopsy forceps and Cold biopsy forceps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2007to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing routine bronchoscopic biopsy for various indications
- More than 18 years of age
Who cannot join
- Bleeding diathesis
- On pacemaker or implanted defibrillator
- On anticoagulation therapy
- Poor cardiopulmonary reserve
- Marked hypoxemia
- Uncooperative patient
- Enrollment in the previous study
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Pulmonary Medicine, PGIMER, India
Chandigarh, Uttarakhand, 160012
About this study
A new electrocautery bronchoscopy biopsy forceps is now commercially available and may prevent bleeding following biopsy. Only one study used this device wherein the authors concluded that the use of hot biopsy forceps for endobronchial biopsy does not appear to have a negative impact on the pathological samples, and that there was a statistically significant, albeit clinically insignificant reduction in bleeding score with hot biopsy forceps. Therefore, a randomized controlled study is required in which the hot and cold biopsies are performed to evaluate the tissue effect of the hot biopsy forceps on histopathological diagnosis.
Read the detailed description
In recent years, a number of innovative non-thoracotomy techniques have been introduced for the diagnosis of indeterminate pulmonary disease but none has had greater impact on pulmonary medicine than flexible fiberoptic bronchoscopy. Since its introduction in 1968, fiberoptic bronchoscopy has become the procedure of choice for diagnosis and management of many bronchopulmonary disorders. It is accompanied by a low incidence of complications and can be performed satisfactorily by the transnasal approach without general anesthesia. Donlan et al, in 1978, and Ackart and colleagues, in 1983, demonstrated the safety of fiberoptic bronchoscopy as an outpatient procedure.
Transbronchial biopsy was first attempted, through a rigid bronchoscope in 1965, but was associated with a high occurrence of pneumothorax. Reports began to appear from 1974 onwards of lung biopsies done for diffuse pulmonary disease using the standard fiberoptic bronchoscope. Forceps biopsy through flexible bronchoscopy is commonly used to make the cytological or histological diagnosis. Of the procedures performed through bronchoscopy, forceps biopsy provides the best diagnostic yield of 71% to 93%.
A new electrocautery ''hot'' bronchoscopy biopsy forceps is now commercially available and may prevent bleeding following biopsy. Only one study used this device wherein the authors concluded that the use of hot biopsy forceps for endobronchial biopsy does not appear to have a negative impact on the pathological samples, and that there was a statistically significant (albeit clinically insignificant) reduction in bleeding score with hot biopsy forceps. However, limitations in this study were small sample size, use of hot and cold biopsy in the same patient as well as interval between the two biopsies were short due to which it is difficult to decide which technique has contributed to the bleeding. Therefore, a randomized controlled study is required in which the hot and cold biopsies are performed to evaluate the tissue effect of the hot biopsy forceps on histopathological diagnosis.
- Conditions
- Endobronchial Growth, Lung Cancer
- Being tested
- Hot biopsy forceps, Cold biopsy forceps
- Keywords
- endobronchial biopsy, bronchoscopy, interventional pulmonology
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot biopsy forcepsDevice
Also called Hot biopsy
Endobronchial biopsies taken with the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps
Cold biopsy forcepsDevice
Also called Cold biopsy
Endobronchial biopsies taken without the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps
| Study group | Role | What they receive |
|---|---|---|
| Hot biopsy | Experimental | Hot biopsy i.e. Endobronchial biopsies taken with the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps Receives: Device: Hot biopsy forceps |
| Cold biopsy | Active comparator | Cold biopsy i.e. Endobronchial biopsies taken without the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps Receives: Device: Cold biopsy forceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of pathological specimen
Measured: 4 hours
Secondary outcomes (1)
Severity of bleeding
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startNov 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endobronchial GrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Investigators
- Ashutosh N Aggarwal, MD, DM, FCCP, Study chair, PGIMER, Chandigrh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963716
- Sponsor's protocol ID
- Khan-1
- Status last verified
- Aug 2009
- First submitted
- 18 Aug 2009
- Last updated
- 21 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hot and Cold Biopsy Forceps in the Diagnosis of Endobronchial Lesions
- ClinicalTrials.gov ID
- NCT00963716
- Acronym / sponsor ID
- Khan-1
- Conditions
- Endobronchial Growth, Lung Cancer
- Keywords
- endobronchial biopsy, bronchoscopy, interventional pulmonology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 21 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A new electrocautery bronchoscopy biopsy forceps is now commercially available and may prevent bleeding following biopsy. Only one study used this device wherein the authors concluded that the use of hot biopsy forceps for endobronchial biopsy does not appear to have a negative impact on the pathological samples, and that there was a statistically significant, albeit clinically insignificant reduction in bleeding score with hot biopsy forceps. Therefore, a randomized controlled study is required in which the hot and cold biopsies are performed to evaluate the tissue effect of the hot biopsy forceps on histopathological diagnosis.
Detailed description
In recent years, a number of innovative non-thoracotomy techniques have been introduced for the diagnosis of indeterminate pulmonary disease but none has had greater impact on pulmonary medicine than flexible fiberoptic bronchoscopy. Since its introduction in 1968, fiberoptic bronchoscopy has become the procedure of choice for diagnosis and management of many bronchopulmonary disorders. It is accompanied by a low incidence of complications and can be performed satisfactorily by the transnasal approach without general anesthesia. Donlan et al, in 1978, and Ackart and colleagues, in 1983, demonstrated the safety of fiberoptic bronchoscopy as an outpatient procedure.
Transbronchial biopsy was first attempted, through a rigid bronchoscope in 1965, but was associated with a high occurrence of pneumothorax. Reports began to appear from 1974 onwards of lung biopsies done for diffuse pulmonary disease using the standard fiberoptic bronchoscope. Forceps biopsy through flexible bronchoscopy is commonly used to make the cytological or histological diagnosis. Of the procedures performed through bronchoscopy, forceps biopsy provides the best diagnostic yield of 71% to 93%.
A new electrocautery ''hot'' bronchoscopy biopsy forceps is now commercially available and may prevent bleeding following biopsy. Only one study used this device wherein the authors concluded that the use of hot biopsy forceps for endobronchial biopsy does not appear to have a negative impact on the pathological samples, and that there was a statistically significant (albeit clinically insignificant) reduction in bleeding score with hot biopsy forceps. However, limitations in this study were small sample size, use of hot and cold biopsy in the same patient as well as interval between the two biopsies were short due to which it is difficult to decide which technique has contributed to the bleeding. Therefore, a randomized controlled study is required in which the hot and cold biopsies are performed to evaluate the tissue effect of the hot biopsy forceps on histopathological diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hot biopsy | Experimental | Device: Hot biopsy forcepsHot biopsy i.e. Endobronchial biopsies taken with the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps |
| Cold biopsy | Active comparator | Device: Cold biopsy forcepsCold biopsy i.e. Endobronchial biopsies taken without the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients undergoing routine bronchoscopic biopsy for various indications
- More than 18 years of age
Key exclusion criteria (7 listed)
- Bleeding diathesis
- On pacemaker or implanted defibrillator
- On anticoagulation therapy
- Poor cardiopulmonary reserve
- Marked hypoxemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hot biopsy forcepsAlso: Hot biopsyEndobronchial biopsies taken with the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps | Device | Hot biopsy |
| Cold biopsy forcepsAlso: Cold biopsyEndobronchial biopsies taken without the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps | Device | Cold biopsy |
Primary outcome
Quality of pathological specimen
Time frame: 4 hours
1 secondary outcome
Severity of bleeding
Time frame: During procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashutosh N Aggarwal, MD, DM, FCCP study chair
PGIMER, Chandigrh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot biopsy forceps and Cold biopsy forceps in people with Endobronchial Growth and Lung Cancer, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of pathological specimen (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2009.