Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm
Recruiting · NCT05838053 · Observational (researchers observe without assigning treatment) · Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
View the official record on ClinicalTrials.gov →Interventions studied
Lobectomy with systemic lymph node dissectionSegmentectomy with systemic lymph node dissection
What this trial is about
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.
Who can take part
Age range
20 Years to 79 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Shanghai Pulmonary Hospital - Yangpu, Shanghai Municipality, China