Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm

Recruiting

• Conditions: Lung Adenocarcinoma
• Interventions: Procedure: Lobectomy with systemic lymph node dissection; Procedure: Segmentectomy with systemic lymph node dissection

• Registration Number: NCT05838053
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief 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.

Detailed Description

At present, the technology of intraoperative frozen section has gradually matured, which can diagnose the benign and malignant tumors and guide the resection strategy for peripheral small-sized lung adenocarcinoma. Travis et al. reported high specificity of intraoperative frozen section in the identification of micropapillary components, confirming that intraoperative frozen section may guide the selection of surgical procedures. However, there is still little evidence whether segmentectomy is appropriate for invasive adenocarcinoma without micropapillary patterns. This prospective and multi-center study was aimed to evaluate the superiority in recurrence free survival and overall survival of lobectomy compared with segmentectomy in patients with lung adenocarcinoma (≤ 2 cm) containing positive micropapillary components.

Study Timeline

• Study Start: 2019-08-20
• Study First Submitted: 2023-04-20
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-05-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27
• Primary Completion: 2028-04-30
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 446

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lobectomy with systemic lymph node dissection	Lobectomy with systemic lymph node dissection	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.
Segmentectomy with systemic lymph node dissection	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 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
overall survival rate	5 year	Overall survival (OS) was defined as the time from surgery until death from any cause

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Yangpu, Shanghai, China