Comparison of two methods of lymph node removal in patients suffering from lung cancer

• Register: ISRCTN
• Last refreshed on: 6 April 2020
• Main ID: ISRCTN86637908
• Date of registration: 20/11/2017
• Prospective Registration: Yes
• Primary sponsor: Jagiellonian University
• Public title: Comparison of two methods of lymph node removal in patients suffering from lung cancer
• Scientific title: Comparison of unilateral and Bilateral Mediastinal Lymph node dissection in patients with non-small cell lung cancer
• Date of first enrolment: 30/11/2017
• Target sample size: 500
• Recruitment status: Ongoing
• URL: http://isrctn.com/ISRCTN86637908
• Study type: Interventional
• Study design: Prospective multicentre study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Austria, China, Germany, Poland, Turkey

Contacts

• Name: Jaroslaw Kuzdzal

Key inclusion & exclusion criteria

Inclusion criteria:
1. Age =18
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)

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Non-small cell lung cancer
Cancer
Non-small cell lung cancer

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

1072.6120.91.2017

Source(s) of Monetary Support

Uniwersytet Jagiellonski w Krakowie, Sun Yat-sen University Cancer Center, Catholic Hospital, Koblenz, Germany , Otto Wagner Hospital, Vienna, Austria , ELK Berlin Chest Hospital, Berlin, Germany , Istanbul University, Cerrahpasa Medical Faculty, Istanbul, Turkey, Thoraxzentrum Ruhrgebiet (Germany), University of Giessen

Ethics review

Status:
Approval date:
Contact:

Bio-ethical Committee of the Jagiellonian University, 30/06/2017, ref: decision No 1072.6120.91.2017

Results

• Results available: Yes
• Date Completed: 31/12/2025