Hot and Cold Biopsy Forceps in the Diagnosis of Endobronchial Lesions

Lung Cancer Clinical Trial

Official title:

Hot and Cold Biopsy Forceps in the Diagnosis of Endobronchial Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963716
• Other study ID #: Khan-1
• Status: Completed
• Phase: N/A
• First received: August 18, 2009
• Last updated: August 20, 2009
• Start date: November 2007
• Est. completion date: July 2009

Study information

• Verified date: August 2009
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. All patients undergoing routine bronchoscopic biopsy for various indications

2. More than 18 years of age

Exclusion Criteria:

1. Bleeding diathesis

2. On pacemaker or implanted defibrillator

3. On anticoagulation therapy

4. Poor cardiopulmonary reserve

5. Marked hypoxemia

6. Uncooperative patient

7. Enrollment in the previous study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Endobronchial Growth
• Lung Cancer

Intervention

Device:
• Hot biopsy forceps
Endobronchial biopsies taken with the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps
• Cold biopsy forceps
Endobronchial biopsies taken without the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps

Locations

Country	Name	City	State
India	Department of Pulmonary Medicine, PGIMER, India	Chandigarh	UT

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of pathological specimen		4 hours	No
Secondary	Severity of bleeding		During procedure	Yes