If biopsy is needed to diagnose ILD, study suggests starting with less invasive options

When a biopsy is required to diagnose interstitial lung disease (ILD), start with a less invasive approach that reduces patient burden while achieving diagnostic yields similar to surgical lung biopsy (SLB). Randomized trials suggest that it can.

A step-up approach (patients undergo transbronchial lung cryobiopsy and SLB is reserved only when more information is needed for diagnosis) requires chest drainage compared to immediate SLB, which requires postoperative hospitalization. The need for has been significantly reduced. – Surgical drainage.

For the study's primary endpoint, unplanned chest drainage occurred in 11% of patients in the step-up group, whereas 46% of patients in the immediate SLB group required prolonged chest drainage (P=0.0058) reported researchers led by Kirsten Kalverda. , MD, University Medical Center Amsterdam.

Additionally, patients assigned to the step-up strategy had shorter hospital stays (median 1 day vs. 5 days, respectively), fewer serious adverse events (4% vs. 50%), and less pain than immediate SLB. There are survey results that show that. Lancet Respiratory Medicine.

“A consensus diagnosis was obtained through discussion by a multidisciplinary team and is considered the reference standard for diagnosing ILD,” explained Kalverda et al. “In most cases, a reliable diagnosis can be established from clinical and radiological data, but in 10-40% of people with newly diagnosed ILD, it is difficult to establish a diagnosis or increase diagnostic confidence. It is estimated that a lung biopsy is considered necessary.

Although lung tissue sampling by SLB is considered the gold standard and is the most commonly used method, it is associated with high morbidity and mortality. On the other hand, transbronchial cryobiopsy has recently become an alternative method, although it has a lower diagnostic yield.

In this study, the diagnostic yield reached 82% with transbronchial cryobiopsy alone, 88% with immediate SLB, and 89% with a step-up strategy.

“Recently published guidelines from the European Respiratory Society suggest performing transbronchial lung cryobiopsy in patients with undiagnosed ILD who require histological diagnosis and are candidates for SLB.” Nashville, Tennessee writes Margaret Salisbury, M.D., of Vanderbilt University Medical Center. said Dr. Kevin Flaherty of the University of Michigan, Ann Arbor, in an invited commentary.

“This recommendation is based on a balance between reducing mortality and other serious complications and reducing diagnostic performance,” the researchers continued. “The guidelines committee also proposed the use of step-up SLB after nondiagnostic transbronchial lung cryobiopsy.”

However, Salisbury and Flaherty said there were no randomized trials to support these conditional recommendations.

Regarding the study results, they noted that some participants in the step-up arm should have progressed to SLB but did not, which may have affected the primary outcome. “It is also likely that many classification diagnoses were made with low confidence,” the researchers added.

Of the 28 patients initially assigned to the minimally invasive approach, only 3 of 5 without a classification diagnosis proceeded to SLB after cryobiopsy.

The editors noted that treatment selection for ILD, a heterogeneous group of more than 10 diseases, relies on identifying a specific diagnosis for appropriate management. However, only 46% of pathologists in the step-up group were able to make the diagnosis with high confidence, compared to 74% in the immediate SLB group.

“While this first-in-class randomized comparison of two effective diagnostic strategies for ILD provides important data in this field, we are walking a fine line balancing diagnostic accuracy with surgical complications. ”, the editors concluded.

The COLD study randomized 55 patients from six Dutch hospitals to either a step-up approach (n=28) or immediate SLB (n=27). If clinical and radiological data are insufficient to establish a classification diagnosis of ILD, and multidisciplinary team discussion indicates the need to obtain lung tissue for diagnosis; Patients were included in the study.

As the primary endpoint, unplanned chest drainage in the step-up group was defined as chest drainage after transbronchial cryobiopsy, whereas prolonged chest drainage after SLB was defined as drainage lasting more than 24 hours. Patients, pathologists, and clinicians were not masked to treatment assignment.

The average age of the patients was 66 years, 81% were male, and about three-quarters were former smokers. Final diagnosis after biopsy included hypersensitivity pneumonitis in 55%, idiopathic nonspecific interstitial pneumonia in 13%, idiopathic pulmonary fibrosis in 8%, sarcoidosis in 4%, unclassifiable in 12%, and other. was 12%.

Overall, adverse events occurred in 61% of patients in the step-up group and 75% of patients in the immediate SLB group. The most common serious adverse events were air leak, pneumonia, and uncontrollable pain.

Kalverda et al. noted that the small sample size and unmasked design may limit the study results. Other potential limitations include the large proportion of cases of hypersensitivity pneumonitis, some variation in baseline measurements, and the fact that all patients underwent surgical intubation.

Elizabeth Short is a staff writer at MedPage Today. She often focuses on pulmonology, allergy and immunology.to follow

disclosure

This study was supported by funding from the Netherlands Agency for Health Research and Development and the University Medical Center Amsterdam.

No disclosures were reported by the study authors.

Mr. Salisbury reported relationships with the NIH, Boehringer Ingelheim, Orinove, and Roche. Mr. Flaherty is a member of the Pulmonary Fibrosis Foundation, Boehringer Ingelheim, Roche/Genentech, Bellerophon, Respivant, Shionogi, DevPro, AstraZeneca, PureHealth, Horizon, Fibrogen, Sun Pharmaceuticals, Pliant, and United Therapeutics. Reported on relationships with Tyx, Arrowhead, Lupin, Polarian, Puretech, and Trevi. , CSL Behring, Daewoong, DisperSol, Immunet, NeRRe Therapeutics, Insilco, Vicore, GSK, Merck, Chugai Pharmaceutical.

Primary information

lancet respiratory medicine

Reference source: Kalverda KA et al. Transbronchial cryobiopsy followed by on-demand versus immediate surgical lung biopsy for the diagnosis of interstitial lung disease (COLD study): a randomized controlled trial ” Lancet Respir Med 2024; DOI:10.1016/S2213-2600(24)00074-2.

secondary sources

lancet respiratory medicine

Source reference: Salisbury ML, Flaherty KR “Optimizing approaches to ILD diagnosis: Balancing procedural complications against diagnostic accuracy” Lancet Respir Med 2024; DOI:10.1016/S2213-2600(24)00113-9.

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