Hot and Cold Biopsy Forceps in the Diagnosis of Endobronchial Lesions
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Endobronchial Growth Lung Cancer |
Device: Hot biopsy forceps Device: Cold biopsy forceps |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | Hot and Cold Biopsy Forceps in the Diagnosis of Endobronchial Lesions |
- Quality of pathological specimen [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- Severity of bleeding [ Time Frame: During procedure ] [ Designated as safety issue: Yes ]
| Enrollment: | 168 |
| Study Start Date: | November 2007 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Hot biopsy
Hot biopsy i.e. Endobronchial biopsies taken with the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps
|
Device: Hot biopsy forceps
Endobronchial biopsies taken with the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps
Other Name: Hot biopsy
|
|
Active Comparator: Cold biopsy
Cold biopsy i.e. Endobronchial biopsies taken without the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps
|
Device: Cold biopsy forceps
Endobronchial biopsies taken without the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps
Other Name: Cold biopsy
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All patients undergoing routine bronchoscopic biopsy for various indications
- More than 18 years of age
Exclusion Criteria:
- Bleeding diathesis
- On pacemaker or implanted defibrillator
- On anticoagulation therapy
- Poor cardiopulmonary reserve
- Marked hypoxemia
- Uncooperative patient
- Enrollment in the previous study
Contacts and Locations| India | |
| Department of Pulmonary Medicine, PGIMER, India | |
| Chandigarh, UT, India, 160012 | |
| Study Chair: | Ashutosh N Aggarwal, MD, DM, FCCP | PGIMER, Chandigrh |
More Information
No publications provided
| Responsible Party: | Ajmal khan, Postgraduate Institute of Medical Education and Research |
| ClinicalTrials.gov Identifier: | NCT00963716 History of Changes |
| Other Study ID Numbers: | Khan-1 |
| Study First Received: | August 18, 2009 |
| Last Updated: | August 20, 2009 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Postgraduate Institute of Medical Education and Research:
|
endobronchial biopsy bronchoscopy interventional pulmonology |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013