Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm (NCT05838053) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm
China446 participantsStarted 2019-08-20
Plain-language 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.
Who can participate
Age range20 Years – 79 Years
SexALL
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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 2ï¼›
* 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 tumorsï¼›
* 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 …
What they're measuring
1
recurrence-free survival rate
Timeframe: 5 year
Trial details
NCT IDNCT05838053
SponsorShanghai Pulmonary Hospital, Shanghai, China