Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital, Zürich | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA concerning the diagnostic yield, the quality and quantity of each biopsy needle without raising the rate of complications.
Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA performed in rigid bronchoscopy for patients with probable lung cancer diagnosis and enlarged mediastinal lymph nodes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Product (19-gauge) | After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle |
| |
| Control Intervention (22-gauge) | After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBUS | Procedure | 19G and 22G EBUS needles are compared in a randomized prospective way in lung cancer patients with enlarged mediastinal lymph nodes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| sample weight | February 2017 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of complications like bleeding, infections, pneumothorax and pain | February 2017 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
100 Patients with lung cancer and enlarged lymph nodes will be included in this study
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kaid Darwiche, PD Dr. med. | supervising doctor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruhrlandklinik, University Hospital Essen | Essen | North Rhine-Westphalia | 45147 | Germany | ||
| University Hospital Zürich |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30914312 | Derived | Wolters C, Darwiche K, Franzen D, Hager T, Bode-Lesnievska B, Kneuertz PJ, He K, Koenig M, Freitag L, Wei L, Eisenmann S, Taube C, Weinreich G, Oezkan F. A Prospective, Randomized Trial for the Comparison of 19-G and 22-G Endobronchial Ultrasound-Guided Transbronchial Aspiration Needles; Introducing a Novel End Point of Sample Weight Corrected for Blood Content. Clin Lung Cancer. 2019 May;20(3):e265-e273. doi: 10.1016/j.cllc.2019.02.019. Epub 2019 Mar 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 16, 2018 | |
| Reset | Feb 7, 2019 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 16, 2018 | Feb 7, 2019 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Zurich |
| Switzerland |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |