Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm With Micropapillary and Solid Subtype Positive by Frozen Section: A Prospective, Observational, Multicenter Cohort Study
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 79
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
China
Shanghai Pulmonary Hospital
RECRUITING
Yangpu
Contact Information
Primary
Long Xu, MD
xulong1228@163.com
15801783037
Time Frame
Start Date:2019-08-20
Estimated Completion Date:2028-04-30
Participants
Target number of participants:446
Treatments
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 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.