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

Comparison of unilateral and Bilateral Mediastinal Lymph node dissection in patients with non-small cell lung cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN86637908

Enrollment

306

Registered

2017-11-20

Start date

2017-11-30

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Austria, China, Germany, Poland, Türkiye

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026