Cold Saline Irrigation Before Endobronchial Biopsy

Not Applicable

• Conditions: Lung Diseases
• Interventions: Other: Flush

• Registration Number: NCT06373224
• Lead Sponsor: TriHealth Inc.

Brief Summary

Patients undergoing an endobronchial ultrasound and biopsy can experience bleeding during the biopsy. These biopsies are read in real time by pathologists who travel to the endoscopy unit during the procedure. Often, when this happens, the blood contaminates the pathology slides making the slide unreadable. This then requires more biopsies to be performed, thus prolonging the procedure, and increasing anesthesia time. One innovative way to reduce bleeding may be to irrigate the bronchial wall with cold saline, where the biopsy is to be taken, immediately before biopsy, thus causing vasoconstriction and possibly resulting in less blood contamination on the biopsy slides. The current study will evaluate this prophylactic irrigation with saline to control bleeding, thus resulting in a quicker diagnostic result of the biopsies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-03
• Study Start: 2023-12-01
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-12-02
• Study Completion: 2027-02-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Undergoing an endobronchial ultrasound and biopsy at Bethesda North Hospital

Exclusion Criteria

• Under 18 years old
• Does not speak English
• Unable to consent to involvement in the research study
• Is pregnant
• Has a bleeding disorder/diagnosis
• Currently taking anticoagulant medications and not stopped for procedure
• Documented low platelets (<100,000)
• Had a biopsy taken immediately prior to the endobronchial ultrasound

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flush Group	Flush	After identifying the lymph node or lesion to be biopsied on ultrasound, using the endobronchial ultrasound scope, two 60mL syringes of cold saline will be inserted, through the biopsy channel of the endobronchial ultrasound scope, directly onto the bronchial wall where the biopsies are to be performed. The saline will then be sucked out of the airway using the endobronchial ultrasound scope.

Primary Outcome Measures

Name	Time	Method
Incidence of unreadable biopsy slides	from enrollment until discharge from biopsy appointment, up to 12 hours	Number of biopsy slides noted by the pathologist to be unreadable due to blood on slide

Trial Locations

Locations (1)

Bethesda North Hospital; 🇺🇸 Cincinnati, Ohio, United States