Hot and Cold Biopsy Forceps in the Diagnosis of Endobronchial Lesions

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Endobronchial Growth
• Intervention / Treatment: Device: Hot biopsy forceps; Device: Cold biopsy forceps

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 Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • UT
    • Chandigarh, UT, India, 160012
      • Department of Pulmonary Medicine, PGIMER, India

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Cold biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quality of pathological specimen	4 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Severity of bleeding	During procedure

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Study Chair: Ashutosh N Aggarwal, MD, DM, FCCP, PGIMER, Chandigrh

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): July 1, 2009

Study Registration Dates

• First Submitted: August 18, 2009
• First Submitted That Met QC Criteria: August 20, 2009
• First Posted (ESTIMATE): August 21, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 21, 2009
• Last Update Submitted That Met QC Criteria: August 20, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: bronchoscopy; endobronchial biopsy; interventional pulmonology
• Other Study ID Numbers: Khan-1