CrYobiopsy With Radial UltraSound Guidance

NCT03506295 | Completed Results FDA Device

• 1 other identifier: 180058
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Transbronchial cryobiopsy carries a higher chance of establishing pathological diagnosis in diffuse parenchymal lung disease (DPLD) than traditional transbronchial forceps guided biopsy. It is a novel technique capable of obtaining large, high-quality samples of lung tissue in a minimally invasive manner. This procedure may decrease the need for surgical lung biopsy in 75% of cases. However, there is an increased risk of pneumothorax and airway bleeding compared to traditional transbronchial forceps guided biopsy. Several strategies are used by practitioners of this technique to mitigate the risks of significant bleeding and pneumothorax. These include prophylactic placement of an endobronchial blocker, the use of fluoroscopy guidance, instillation of cold saline to promote vasoconstriction, and establishment of a secure airway with endotracheal tube placement or rigid bronchoscopy . Vanderbilt University Medical Center is one of the most active centers in terms of cryobiopsies performed as part of the diagnostic workup of DPLD. Currently all transbronchial cryobiopsies here are performed under fluoroscopic guidance, with endotracheal tube intubation and endobronchial blocker placement. Despite these precautions, post biopsy bleeding complications occur and can substantially lengthen the duration of the procedure and occasionally expose patients to procedural complications. Radial ultrasound has been well utilized to define anatomy of peripheral lung and localization of peripheral pulmonary nodules. We postulate that using radial ultrasound to identify peribronchial lung parenchyma with low vascularity will mitigate the risk of hemorrhage during peripheral lung cryobiopsy in patients with DPLD and hence improve patient safety.

Conditions

Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Time to Achieve Hemostasis After Obtaining Cryobiopsy

  This is defined as time from when the bronchoscope and cryoprobe are removed en bloc after obtaining the cryobiopsy to the time when it is determined to be safe to proceed to next cryobiopsy("Ready for next biopsy").

  From time of randomization up to 120 minutes.

Secondary Outcomes (4)

• Grade of Bleeding

  From time of randomization up to 120 minutes.

• Number of Biopsies That Required Additional Interventions to Manage Bleeding

  From time of randomization up to 120 minutes.

• Biopsy Specimen Quality

  From time of randomization until acquisition of results from pathology, assessed up to 12 months.

• Biopsy Size

  From time of randomization until acquisition of results from pathology, assessed up to 12 months.

Study Arms (2)

Control

OTHER

Standard of Care - Transbronchial cryobiopsies are obtained as a standard of care under fluoroscopy guidance

Device: Flouroscopy

Intervention

EXPERIMENTAL

In the intervention arm , radial ultrasound probe will be used in addition to standard of care described above to confirm adequate position of the cryoprobe before transbronchial cryobiopsy is obtained.

Device: Radial Endobronchial Ultrasound Probe; Device: Flouroscopy

Interventions

Radial Endobronchial Ultrasound Probe DEVICE

The radial EBUS procedure is performed by inserting a miniature ultrasound probe (radial EBUS probe) through the working channel of a flexible bronchoscope or catheter (guide sheath). Real-time imaging of the surrounding tissue enables the clinician to determine the lesion's exact location and size.

Intervention

Flouroscopy DEVICE

Real-time fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement.

Control; Intervention

Eligibility Criteria

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

You may qualify if:

• Referral to interventional pulmonary services for diagnostic transbronchial cryobiopsy for diffuse parenchymal lung disease.
• Transbronchial cryobiopsy is determined to be appropriately indicated as determined by consulting interventional pulmonologist.
• Age \> 18 years

You may not qualify if:

• Inability to provide informed consent
• Study subject has any condition that interferes with safe completion of the study including:
• Coagulopathy, with criteria left at the discretion of the operator
• Respiratory insufficiency with DLCO \< 30% or baseline requirements of oxygen \>2 liters
• Hemodynamic instability with systolic blood pressure \<90 mmHg or heart rate \> 120 beats/min, unless deemed to be stable with these values by the attending physicians
• Patients representing vulnerable populations (prisoners, pregnant women, etc.)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Limitations and Caveats

1. Considering the difference in thickness and flexibility of cryoprobe as compared to REBUS probe, thei positioning may not always truly coincide. 2. Operator dependent observer's bias while obtaining hemostasis.

Results Point of Contact

• Title: Dr. Fabien Maldonado
• Organization: Vanderbilt University Medical Center

fabien.maldonado@vumc.org

615-322-3412

Study Officials

• Fabien Maldonado, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Primary bronchoscopist will perform localization of biopsy spot, after biopsy is determined to be in the control or intervention group. He/she will then perform the cryobiopsy per protocol. A bedside assistant will assist in managing the endobronchial blocker at all times. Secondary bronchoscopist will be stationed outside the operating room during initial part of the procedure. He will be prompted to enter the room by research coordinator to take control of the bronchoscope and assess post cryobiopsy bleeding. He will hence be blinded to the use or non-use of radial probe ultrasound. Research coordinator will be present at all times and will coordinate the switching process between proceduralists. Reference image of the radial USG determining the biopsy location on fluoroscopy monitor will be erased before secondary bronchoscopist enters the room. Patient will be blinded as he/she will be sedated. Four biopsies will be planned per procedure, two each from control \& intervention arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: April 24, 2018
• Study Start: April 6, 2018
• Primary Completion: October 3, 2018
• Study Completion: October 3, 2018
• Last Updated: November 12, 2019
• Results First Posted: November 12, 2019

Record last verified: 2019-10

Locations

US (1)