Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm

NCT05838053 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Phase

Observational

Started

2019-08-20

Last updated

2023-07-27

Condition(s) studied

Lung Adenocarcinoma

Investigational drug(s) / intervention(s)

Lobectomy with systemic lymph node dissectionSegmentectomy with systemic lymph node dissection

Lobectomy with systemic lymph node dissection: Lobectomy with hilar and mediastinal lymph node dissection is performed. Segmentectomy 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. The distance from the dissection margin to the tumor edge must be evaluated intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.

Segmentectomy with systemic lymph node dissection: 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. 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 intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.

Study summary

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.

Eligibility

Sex

ALL

Min age

20 Years

Max age

79 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

recurrence-free survival rate — 5 year
Recurrence-free survival (RFS) was defined as the time from surgery until recurrence or death from any cause

Trial sites (1)

Facility	City	Region	Status
Shanghai Pulmonary Hospital	Yangpu	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05838053 on ClinicalTrials.gov ↗ ← All trials in China