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Mediastinal Staging Accuracy of a Selective Lymphadenectomy Strategy in Early Stage NSCLC (ECTOP-1003)

NCT03216551 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1076

Last updated 2023-07-20

No results posted yet for this study

Summary

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1003. Systemic mediastinal lymphadenectomy is deemed indispensable in lung cancer surgery for accurate staging and complete resection. However, extensive lymphadenectomy in patients without nodal metastasis may not improve survival and would increase operative duration and cause damage to mediastinal structures.Therefore the precise selection of patients without mediastinal nodal metastasis is the key to avoid unnecessary lymphadenectomy.The investigator's previous retrospective study shows tumor location, ground glass opacity component and histological subtypes are important predictors of negative nodal status in specific mediastinal regions. The current prospective observational study is to further verify the mediastinal staging accuracy of this selective lymphadenectomy strategy.

Conditions

  • Lymph Node Metastases
  • Non-small Cell Lung Cancer Stage I

Interventions

DIAGNOSTIC_TEST

Intra-operative frozen section

Tumor histologic subtypes (whether it is lepidic predominant adenocarcinoma), N1 nodes metastasis (lymph nodes adjacent to the tumor will be sent to frozen section) and visceral pleural invasion will be determined by the intra-operative frozen section.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Haiquan Chen, MD,PhD · Fudan University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-14
Primary Completion
2022-05-30
Completion
2022-05-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03216551 on ClinicalTrials.gov