Clinical trial NCT00963716: Hot and Cold Biopsy Forceps in the Diagnosis of Endobronchial Lesions
Official title: Hot and Cold Biopsy Forceps in the Diagnosis of Endobronchial Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endobronchial Growth
Lung Cancer
Keywords: endobronchial biopsy
bronchoscopy
interventional pulmonology
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2009-08-21
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

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 criteria: 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

Primary outcomes:
measure: Quality of pathological specimen
timeFrame: 4 hours
Secondary outcomes:
measure: Severity of bleeding
timeFrame: During procedure
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Department of Pulmonary Medicine, PGIMER, India
state: UT
Study officials:
affiliation: PGIMER, Chandigrh
name: Ashutosh N Aggarwal, MD, DM, FCCP
role: STUDY_CHAIR
References: