Comparison of two methods of lymph node removal in patients suffering from lung cancer
| ISRCTN | ISRCTN86637908 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86637908 |
| Secondary identifying numbers | 1072.6120.91.2017 |
- Submission date
- 09/11/2017
- Registration date
- 20/11/2017
- Last edited
- 24/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Lung cancer is the number 1 killer among all malignancies in both sexes. The most effective way to treat it is complete surgical resection (removal of part of the lung), which is possible in less advanced cases. Together with the diseased part of the lung, also lymph nodes are removed, as they often are cancer deposits. The standard systematic lymph node dissection (SLND) removes nodes but this only removes nodes from one side of the chest. Unfortunately, cancer deposits can develop also in the contralateral (opposite) side of the chest. This study is aimed at assessment of bilateral removal of the lymph nodes during lung cancer surgery.
Who can participate?
Adults aged 18 with non-small cell lung cancer.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group have their lung resection done with the standard procedure. Those in the second group receive the standard procedure as well as an additional lymph node dissection in the other side of their chest through a neck incision. Participants are followed for operative time, blood loss, number of lymph nodes removed and any other complication during the surgery. Participants are followed up after the surgery for their pain and survival.
What are the possible benefits and risks of participating?
The potential benefit is more complete resection achieved with bilateral removal of lymph nodes, resulting in better chance for cure. There is a possible increased risk of adverse effects as the procedure is more invasive.
Where is the study run from?
This study is being run by Jagiellonian University and takes place in hospitals in Poland, China, Germany, Austria, and Turkey.
When is the study starting and how long is it expected to run for?
January 2017 to December 2025
Who is funding the study?
1. Jagiellonian University in Krakow (Poland)
2. Sun Yat-sen University Cancer Center (China)
3. Catholic Hospital Koblenz (Germany)
4. Otto Wagner Hospital, Vienna (Austria)
5. ELK Berlin Chest Hospital, Berlin (Germany)
6. Istanbul University, Cerrahpasa Medical Faculty (Turkey)
7. Thoraxzentrum Ruhrgebiet (Germany)
8. University of Giessen (Germany)
Who is the main contact?
Professor Jaroslaw Kuzdzal
Contact information
Scientific
Department of Thoracic Surgery
Jagiellonian University
ul. Pradnicka 80
Cracow
31-202
Poland
Study information
| Study design | Prospective multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN86637908_PIS_13Nov17.doc |
| Scientific title | Comparison of unilateral and Bilateral Mediastinal Lymph node dissection in patients with non-small cell lung cancer |
| Study acronym | BML-2 |
| Study objectives | In patients operated on for non-small cell lung cancer, bilateral mediastinal lymph node dissection is associated with improved survival as compared with standard systematic lymph node dissection. |
| Ethics approval(s) | Approved 30/06/2017, Bioethical Committee of the Jagiellonian University (ul. Podwale 3/5, Cracow, 31-118, Poland; +48123704386; kbet@cm-uj.krakow-pl), ref: 1072.6120.91.2017 |
| Health condition(s) or problem(s) studied | Non-small cell lung cancer |
| Intervention | Prospective multicentre study with 1:1 randomisation using computer-generated random numbers. The intervention group includes patients undergoes bilateral mediastinal lymph node dissection (BML), and the control group includes participants who undergo standard systematic lymph node dissection (SLND). Randomisation in the ratio 1:1 using computer-based random digit generator. All participants receive anatomical lung resection with SLND is performed according to the ESTS guidelines. VATS and thoracotomy approaches are acceptable. In the BML group, additional contralateral lymph node dissection is performed during the same anaesthesia, via separate neck incision (using either the VAMLA technique,10 or modified TEMLA technique15). The following intraoperative parameters are recorded: operative time, blood loss, number of lymph nodes removed from each nodal station, any complications. The following postoperative parameters are recorded: volume of chest tube output, time of chest drainage, time of air leak, pain intensity measured using the visual analogue scale (VAS), any complications, tumour relapse and survival recorded at least every three months in the first three years, and at least every six months in the 4th and 5th year after surgery. Patients with stage pII or pIII (according to the final pathological report) are referred for adjuvant platinum-based chemotherapy. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Overall and cancer-specific 5-year survival rate is measured using the CRF data at 5-year survival is by definition measured 5 years after initiation of the treatment 2. DFS is measured using the CRF data at the time of closing the study 5 year after treatment of the last patient included |
| Secondary outcome measures | 1. Operative time is measured using case report forms at the end of the procedure 2. Blood loss is measured using the scale of the suction device container at the end of the procedure 3. Pain intensity measured using VAS every 4 hours at the days 0, 1, 2, 3, 4, and 5 4. Complications is measured using the CRF data that include records of 45 categories of adverse effects at day of discharge 5. Length of hospital stay is measured using hospital records at the day of discharge 6. Number of removed lymph nodes in each station is counted by the pathologist during the final pathological examination of the surgical specimen |
| Overall study start date | 15/01/2017 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 306 |
| Total final enrolment | 307 |
| Key inclusion criteria | 1. Age ≥18 years 2. Proven or suspected NSCLC 3. Clinical stage I, II or minimal N2 IIIA, assessed on the basis of CT, PET-CT (except of T1a-b), bronchoscopy and EBUS/EUS (except of T1a-b) 4. General fitness enabling appropriate pulmonary resection (according to the ERS/ESTS guidelines) (both genders are included, this onfo has been given elsewhere in your on-line form) |
| Key exclusion criteria | 1. History of other malignance (except on non-melanoma skin cancer) 2. Final pathological report of tumour other than NSCLC 3. Final pathological report of carcinoid or salivary gland-type tumour 4. Intraoperative finding of M1 disease |
| Date of first enrolment | 30/11/2017 |
| Date of final enrolment | 24/05/2022 |
Locations
Countries of recruitment
- Austria
- China
- Germany
- Poland
- Türkiye
Study participating centres
Jagiellonian University
Krakow
31-202
Poland
Guangzhou
510060
China
Cerrahpasa Medical Faculty
Istanbul
34734
Türkiye
Sponsor information
Hospital/treatment centre
Department of Thoracic Surgery
ul. Pradnicka 80
Cracow
31-202
Poland
"ROR" |
https://ror.org/03bqmcz70 |
|---|
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Universitas Jagellonica Cracoviensis, Jagiellonian University in Krakow, UJ
- Location
- Poland
No information available
No information available
No information available
No information available
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No information available
Results and Publications
| Intention to publish date | 31/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The study is planned to be presented during oncological and thoracic surgical conferences, and publication of its results is planned in high-impact peer-reviewed journals. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the legal regulations of patients' data protection. The data will be stored at the John Paul II Hospital, Krakow, Poland. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 13/11/2017 | 02/04/2019 | No | Yes | |
| Results article | 02/07/2024 | 04/07/2024 | Yes | No | |
| Results article | 08/01/2025 | 10/01/2025 | Yes | No |
Additional files
- ISRCTN86637908_PIS_13Nov17.doc
- Uploaded 02/04/2019
Editorial Notes
24/01/2025: The following changes were made to the study record:
1. Ethics approval details added.
2. The target number of participants was changed from 500 to 306.
3. The total final enrolment was changed from 983 to 307.
4. The recruitment end date was changed from 31/12/2021 to 24/05/2022.
5. Catholic Hospital, Otto Wagner Hospital, ELK Berlin Chest Hospital, Thoraxzentrum Ruhrgebiet, University of Giessen were removed from the study participating centres.
10/01/2025: Publication reference and total final enrolment added.
04/07/2024: Publication reference added.
19/03/2020: The recruitment end date was changed from 31/12/2020 to 31/12/2021.
19/08/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2019 to 31/12/2020.
2. The overall trial end date was changed from 31/12/2019 to 31/12/2025.
3. The intention to publish date was changed from 31/12/2020 to 31/03/2020.
02/04/2019: The participant information sheet has been uploaded.
