Clinical trial · Observational
Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm
Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm With Micropapillary and Solid Subtype Positive by Frozen Section: A Prospective, Observational, Multicenter Cohort Study
NCT05838053CI-TRIAL-00068286recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to evaluate the superiority in recurrence-free survival of lobectomy compared with segmentectomy in patients with lung adenocarcinoma ≤ 2 cm with micropapillary and solid subtype positive by intraoperative frozen sections.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lobectomy with systemic lymph node dissection | Procedure | — | UNRESOLVED |
| Segmentectomy with systemic lymph node dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Lobectomy with systemic lymph node dissection
- description
- lobectomy with hilar and mediastinal lymph node dissection is performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively.
- interventionNames
- Procedure: Lobectomy with systemic lymph node dissection
- label
- Segmentectomy with systemic lymph node dissection
- description
- Segmentectomy with hilar and mediastinal lymph node dissection is performed. If the tumor located at inter-segment plane and without sufficient resection margin distance, a combined segmentectomy will be performed after a comprehensive evaluation. As with lobectomy, systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated in the same manner as with lobectomy.
- interventionNames
- Procedure: Segmentectomy with systemic lymph node dissection
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Tumor size ≤ 2 cm; * Solitary tumor and located in the outer third of the lung field; * Preoperative CT indicated that the nodules were single nodules or Concomitant nodules was less than minimal invasive adenocarcinoma; * Intraoperative frozen section confirmed invasive lung adenocarcinoma and with micropapillary and solid patterns positive (\>5%); * Confirmation of R0 status by intraoperative frozen section analysis; * Pulmonary function could withstand both segmentectomy and lobectomy (FEV1 \> 1.5 L or FEV1% ≥ 60%); * Sufficient organ function; * Performance status of 0,1 or 2； * Written informed consent. Exclusion Criteria: * The tumor is close to the hilum, which cannot perform segmentectomy ; * Patients suspected of lymph node positive by preoperative examination, including CT scans and mediastinal lymph node biopsy; * Evidence revealed locally advanced or metastatic disease; * Intraoperative exploration revealed accidental pleural dissemination. * Patients with severe damage to heart, liver and kidney function (grade 3 \~ 4, Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) over 3 times the normal upper limit, Cr over the normal upper limit). * Patients concomitant with other malignant tumors； * Patients had prior chemotherapy, radiotherapy or molecular targeted therapy for this malignancy. * History of severe heart disease, heart failure, myocardial infarction within the past 6 months. * The patients who were not suitable for inclusion by researchers' evaluation.
References
Publications (0)
Data not yet available
No reference posted for this study.