Cold Saline Irrigation Before Endobronchial Biopsy

NCT06373224 | Terminated Results

• 1 other identifier: 23-037
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases

Keywords

Biopsy

Outcome Measures

Primary Outcomes (1)

• Unreadable Biopsy Slides

  cumulative number of unreadable slides across all biopsy slides noted by the pathologist to be unreadable due to blood on slide

  from enrollment until discharge from biopsy appointment, up to 12 hours

Study Arms (2)

Flush Group

EXPERIMENTAL

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.

Other: Flush

Standard Care Group

NO INTERVENTION

No irrigation before the biopsy

Interventions

Flush OTHER

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.

Flush Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing an endobronchial ultrasound and biopsy at Bethesda North Hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Results Point of Contact

• Title: Nurse Researcher
• Organization: TriHealth

Rachel_Baker2@trihealth.com

5135696191

Study Officials

• Austin Pittman, BSN, RN

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: April 18, 2024
• Study Start: December 1, 2023
• Primary Completion: May 23, 2025
• Study Completion: December 30, 2025
• Last Updated: April 2, 2026
• Results First Posted: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)