NCT04743583

Prevalence and Malignant Involvement of Calcified Intrathoracic Lymph Nodes in Patients Undergoing Endosonography

Prevalence of Intrathoracic Lymph Node Calcifications and Metastatic Involvement in Patients Undergoing Endosonography for Diagnosis and/or Mediastinal Staging of Intrathoracic Malignancy: a Cross-sectional Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 362 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: —

Summary

The presence of calcifications, which is a relatively common feature in intrathoracic lymph nodes, typically contributes to confer them a heterogeneous aspect during endosonographic B-mode examination, but their prevalence and a possible association between calcifications and metastatic involvement has never been systematically evaluated. We hypothesize that, in patients undergoing mediastinal diagnosis or staging of suspected/known lung cancer/intrathoracic malignancies, the prevalence of lymph node metastases is similar in calcified and non-calcified lymph nodes.

Detailed description

The presence of calcifications, which is a relatively common feature in intrathoracic lymph nodes, typically contributes to confer them a heterogeneous aspect during endosonographic B-mode examination, but a possible association between calcifications and metastatic involvement has never been systematically evaluated. The most likely reason why this possible association has been overlooked up to now is that the presence of calcifications in intrathoracic lymph nodes has long been thought to be the consequence of the prior involvement from granulomatous diseases (i.e., tuberculosis or sarcoidosis), and as such has been considered a sign of benignity. However, the presence of lymph node calcifications at ultrasound examination is a known predictor of lymph node metastasis in patients with some specific tumours, such as the papillary thyroid carcinoma or the squamous cell carcinoma of head or neck. Furthermore, recent radiological-pathological studies have shown that metastatic foci from lung cancer are observed in up to 19% calcified mediastinal lymph nodes identified at CT in surgical candidates. Finally, a recently published EBUS study has reported, for the first time, a very strong association between a very specific pattern of mediastinal lymph node calcification, known as "starry sky sign", and metastasis from pulmonary, colonic and breast adenocarcinoma. Interestingly, the starry sky sign is characterized by the presence of few to countless dot-like calcifications which are too small to be seen at CT and can be identified only during EBUS B-mode examination. To the best of our knowledge, no studies have been carried out to assess the correlation between the presence and the ultrasound pattern of lymph node calcifications and lymph node metastasis from lung cancer or other intrathoracic malignancies.

Conditions

• Lymphadenopathy
• Lung Cancer
• Sarcoidosis
• Tuberculosis

Interventions

Type	Name	Description
DEVICE	Endosonography B-mode examination	Endobronchial ultrasound (EBUS) or Endoscopic with bronchoscope (EUS-B) B-mode examination and sampling, when indicated, of lymphadenopathy

Timeline

• Start date: 2021-03-20
• Primary completion: 2022-04-30
• Completion: 2022-12-31
• First posted: 2021-02-08
• Last updated: 2023-01-10

Locations

1 site across 1 country: Italy