Actively Recruiting
Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm With Micropapillary and Solid Subtype Positive by Frozen Section: A Prospective, Observational, Multicenter Cohort Study
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2023-07-27
446
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the recurrence-free survival and overall survival between lobectomy and segmentectomy in patients with lung adenocarcinoma tumors 2 cm or smaller that have micropapillary and solid subtypes, as identified by intraoperative frozen sections. The study addresses the need for evidence on whether segmentectomy is appropriate for invasive adenocarcinoma with these features. It is a prospective, multicenter cohort study conducted to evaluate these surgical approaches in such patients. Participants will undergo either lobectomy or segmentectomy, both performed with systemic or selective hilar and mediastinal lymph node dissection involving at least three mediastinal lymph node stations depending on the side of the lung. In segmentectomy, if the tumor is located at an inter-segment plane and the resection margin is insufficient, a combined segmentectomy will be performed after evaluation. The distance from the tumor edge to the resection margin will be assessed intraoperatively in both procedures to confirm absence of cancer cells before completing surgery. During the study, patients will be monitored for recurrence-free survival over five years, with overall survival also measured at five years. Pulmonary function and organ function will be assessed to confirm eligibility for surgery. The study involves careful intraoperative frozen section analysis to guide surgical decisions and ensure clear resection margins. Participants will be followed to evaluate long-term outcomes of these surgical treatments for lung adenocarcinoma.
CONDITIONS
Brief Title
Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Tumor size 2 cm or smaller
- Solitary tumor located in the outer third of the lung field
- Preoperative CT shows single nodules or concomitant nodules less than minimal invasive adenocarcinoma
- Intraoperative frozen section confirms invasive lung adenocarcinoma with micropapillary and solid patterns positive over 5%
- Confirmation of complete (R0) tumor removal by intraoperative frozen section
- Pulmonary function sufficient for segmentectomy and lobectomy (FEV1 > 1.5 L or FEV1% ≥ 60%)
- Sufficient organ function
- Performance status of 0, 1, or 2
- Provided written informed consent
You will not qualify if you...
- Tumor close to the hilum preventing segmentectomy
- Suspicion of positive lymph nodes by preoperative exams including CT and biopsy
- Evidence of locally advanced or metastatic disease
- Accidental pleural dissemination found during surgery
- Severe heart, liver, or kidney damage (grade 3-4) or elevated liver enzymes or creatinine
- Presence of other malignant tumors
- Prior chemotherapy, radiotherapy, or targeted therapy for this cancer
- History of severe heart disease, heart failure, or myocardial infarction within 6 months
- Deemed unsuitable for inclusion by researchers' evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate recovery period
Participants undergo either lobectomy or segmentectomy with systemic lymph node dissection. The surgical procedure includes evaluation of tumor margins intra-operatively to confirm complete tumor removal.
1 surgical visit (in-person)
Duration - Up to 5 years
Participants are followed after surgery to monitor their recovery and health status.
Regular follow-up visits over 5 years
Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Yangpu, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
L
Long Xu, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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