Safety Profile of Ultrasound-guided Transparietal Lung Biopsy in Patients With Diffuse Interstitial Lung Disease

NCT07305220 | Not Yet Recruiting DMC

• 2 other identifiers: DR2401612024-A01304-43
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale Interstitial lung diseases (ILDs) require accurate histological diagnosis when imaging is inconclusive, yet current techniques-surgical lung biopsy and transbronchial cryobiopsy-carry significant risks and lack real-time guidance. BPTE, widely used in oncology, provides ultrasound-guided sampling under local anesthesia with historically lower complication rates, but its value in ILD remains unproven. The TOUCANS study aims to generate safety and feasibility data to support its potential use as a less invasive diagnostic alternative. Objectives The primary objective is to assess the safety of BPTE in ILD patients, focusing on major adverse events: death, pneumothorax requiring drainage, hemorrhage requiring intervention, and prolonged pleural drainage. Secondary objectives include evaluating all complications within two months, comparing BPTE histological quality with surgical biopsy, and assessing pain, dyspnea, analgesic use, healing, drainage duration, and hematoma on thoracoscopic imaging. Materials and Methods Fifteen patients aged 18-75 with ILD requiring tissue diagnosis after multidisciplinary review will be included. Exclusion criteria cover coagulation disorders, severe comorbidities, long-term oxygen therapy, impaired lung function, obesity, pulmonary hypertension, anesthetic allergy, and vulnerable populations. BPTE will be performed 2-4 weeks before surgical biopsy, under local anesthesia and spontaneous ventilation, with CT- and ultrasound-guided targeting. One or two biopsies will be taken, followed by ultrasound and chest X-ray monitoring; discharge occurs after four hours if stable. Surgical thoracoscopic biopsy will then be carried out with standard postoperative care. Pain, dyspnea, healing, and imaging findings will be recorded, and histological samples will be reviewed blindly. Data will be captured in eCRFs according to GDPR/CNIL requirements. Expected Outcomes TOUCANS will provide the first prospective evidence on BPTE for ILD. Demonstrating safety and adequate diagnostic yield could position BPTE as a minimally invasive, outpatient, ultrasound-guided alternative to surgical biopsy. This may shorten diagnostic pathways, reduce complications, and offer a viable option for patients unsuitable for surgery, ultimately improving early management and prognosis.

Conditions

Interstitial Lung Disease (ILD)

Keywords

Interstitial Lung Disease (ILD); Transthoracic Ultrasound-Guided Biopsy (BPTE); Safety Assessment; Histological Diagnosis

Outcome Measures

Primary Outcomes (1)

• Occurrence of serious complications between BPTE and SLB

  The study monitors for the following adverse events: * Death related to the procedure * Pneumothorax requiring pleural drainage * Pulmonary or chest wall hemorrhage necessitating medical intervention, such as Blood transfusion, Arterial embolization, Surgical management This endpoint is designed to evaluate the safety and feasibility of BPTE as a diagnostic tool, particularly in comparison to more invasive procedures like surgical biopsy. The goal is to determine whether BPTE can be safely performed in an outpatient setting with an acceptable risk profile for serious complications.

  From BPTE to the surgical biopsy (2-4 weeks)

Secondary Outcomes (9)

• All complications up to 2 months

  From BPTE to 2-month post-surgical biopsy visit

• Duration of pleural drainage

  Between BPTE procedure and surgical biopsy.Between surgical biopsy and 1-month post-surgical biopsy visit.

• Histological diagnoses

  During BPTE procedure, during surgical biopsy

• Pain assessment

  After BPTE and after surgical biopsy: Evaluation at the end of the procedure, after 1hour, 2hours, 3hours, 4hours, 24hours, 2days, 7days, 14days. At 1-month and 2-month post-surgical biopsy visits.

• Type of analgesics used

  After the BPTE until the surgical biopsy. After the surgical biopsy until the visit at 1 month. At 1-month and 2-month post-surgical biopsy visits.

Study Arms (1)

Transthoracic ultrasound-guided lung biopsy

EXPERIMENTAL

patients with surgical lung biopsy indication validated by MDD

Procedure: Transthoracic ultrasound-guided lung biopsy

Interventions

Transthoracic ultrasound-guided lung biopsy PROCEDURE

* Scheduled 2-4 weeks before SLB * Performed under local anesthesia and spontaneous ventilation * Target zone identified via CT and ultrasound (B-lines \>3/field or pleural irregularities) * Biopsy performed using a specialized needle during brief apnea * One or two samples taken depending on quality (\>1 cm)

Transthoracic ultrasound-guided lung biopsy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• Diagnosed with diffuse ILD
• Histological analysis required after standard diagnostic workup
• Biopsy indication validated by MDD
• Affiliated with French social security

You may not qualify if:

• Contraindication to SLB
• Coagulation disorders
• Significant comorbidities affecting safety
• Long-term oxygen therapy
• FVC \<55%, DLCO \<40%
• BMI \>35 kg/m²
• Pulmonary hypertension (PAPS \>40 mmHg)
• Allergy to anesthetics
• Protected populations (pregnant women, minors, legally protected adults)
• β-HCG test required for non-menopausal women

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Pneumology department

Tours, France

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Sylvie LEGUE, PH

CONTACT

33 +2 47 47 37 87; S.LEGUE@chu-tours.fr

Sylvain MARCHAND-ADAM, PU-PH

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Primary Purpose : safety

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 26, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)