Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm

Trial Title: Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm

NCT ID: NCT05838053

Condition: Lung Adenocarcinoma

Conditions: Official terms:
Adenocarcinoma
Adenocarcinoma of Lung

Conditions: Keywords:
frozen sections
lobectomy
segmentectomy
micropapillary

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Procedure
Intervention name: Lobectomy with systemic lymph node dissection
Description: Lobectomy with hilar and mediastinal lymph node dissection is performed. Segmentectomy 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. The distance from the dissection margin to the tumor edge must be evaluated intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.
Arm group label: Lobectomy with systemic lymph node dissection

Intervention type: Procedure
Intervention name: Segmentectomy with systemic lymph node dissection
Description: 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. 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 intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.
Arm group label: Segmentectomy with systemic lymph node dissection

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.

Detailed 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 whether segmentectomy is appropriate for invasive adenocarcinoma without micropapillary patterns. This prospective and multi-center study was aimed to evaluate the superiority in recurrence free survival and overall survival of lobectomy compared with segmentectomy in patients with lung adenocarcinoma (≤ 2 cm) containing positive micropapillary components.

Criteria for eligibility:

Study pop:
clinical stage IA patients with Lung Adenocarcinoma ≤ 2cm as well as micropapillary and solid Subtype positive (>5%) by frozen sections

Sampling method: Non-Probability Sample
Criteria:
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.

Gender: All

Minimum age: 20 Years

Maximum age: 79 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Shanghai Pulmonary Hospital

Address:
City: Yangpu
Zip: 200433
Country: China

Status: Recruiting

Contact:
Last name: Deping Zhao, MD, PhD

Phone: +86-021-65115006
Email: dpzhao@tongji.edu.cn

Start date: August 20, 2019

Completion date: April 30, 2028

Lead sponsor:
Agency: Shanghai Pulmonary Hospital, Shanghai, China
Agency class: Other

Source: Shanghai Pulmonary Hospital, Shanghai, China

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05838053