Segmentectomy Versus Lobectomy for Lung Adenocarcinoma 2cm

  • STATUS
    Recruiting
  • End date
    Apr 30, 2028
  • participants needed
    690
  • sponsor
    Shanghai Pulmonary Hospital, Shanghai, China
Updated on 3 July 2021
Investigator
Hang Su
Primary Contact
Shanghai Pulmonary Hospital (5.5 mi away) Contact
+5 other location

Summary

This study aims to evaluate the non-inferiority in recurrence-free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma 2 cm with micropapillary and solid subtype negative by intraoperative frozen sections.

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 weather segmentectomy is appropriate for invasive adenocarcinoma without micropapillary patterns. This prospective and multi-center study was aimed to evaluate the non-inferiority in recurrence free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma ( 2 cm) not including micropapillary components.

Details
Condition Lung Adenocarcinoma
Treatment Segmentectomy with systemic lymph node dissection, Lobectomy with hilar and mediastinal lymph node dissection
Clinical Study IdentifierNCT04937283
SponsorShanghai Pulmonary Hospital, Shanghai, China
Last Modified on3 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient age 20-79 years old
Tumor size 2 cm
Solitary tumor and located in the outer third of the lung field
Preoperative CT indicated that the nodules were non-pure glass nodules (CTR 0.25)
Intraoperative frozen section confirmed invasive lung adenocarcinoma and with micropapillary patterns negative
Confirmation of R0 status by intraoperative frozen section analysis
Pulmonary function could withstand both segmentectomy and lobectomy (FEV1 > 70%)
Sufficient organ function
Performance status of 0,1 or 2
Written informed consent

Exclusion Criteria

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, ALT and/or AST over 3 times the normal upper limit, Cr over the normal upper limit)
Patients concomitant with other malignant tumors
Women during pregnancy or breast-feeding
Systemic steroidal medication
Patients had prior chemotherapy or radiation therapy for this malignancy
History of severe heart disease, heart failure, myocardial infarction within the past 6 months
Participated in other relevant clinical trial within three months
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