Systematic Sampling of Lymph Nodes vs. Lymphadenectomy According to Intraoperative Frozen Pathology for Pulmonary Invasive Adenocarcinoma With Ground-glass Opacity

Lymph Node Excision Clinical Trial

Official title:

A Prospective and Multi-center RCT Study of Lymphadenectomy Based on Intraoperative Frozen Pathology for Pulmonary Invasive Adenocarcinoma Presenting With Ground Glass Opacity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03322826
• Other study ID #: SHDC12015116
• Status: Recruiting
• Phase: N/A
• First received: October 23, 2017
• Last updated: December 15, 2017
• Start date: December 8, 2017
• Est. completion date: October 28, 2023

Study information

• Verified date: December 2017
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Chang Chen, M.D. Ph.D.
• Phone: 13816869003
• Email: chenthoracic[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the impact of systematic sampling of lymph nodes vs. lymphadenectomy on outcome according to intraoperative frozen pathology for pulmonary invasive adenocarcinoma with ground-glass opacity (GGO) after VATS lobectomy.

Description:

On HRCT screening, early lung adenocarcinoma often contains a nonsolid component called ground-glass opacity (GGO). In 2011, pulmonary adenocarcinomas were classified into atypical adenomatous hyperplasia (AAH), adenocarcinoma in situ (AIS), minimally invasive carcinoma (MIA) and more extensively invasive adenocarcinoma (IAC) [1]. Early adenocarcinomas with GGO-dominant always mean low-grade malignancy and have an extremely favorable prognosis [2-5]. Previous studies have shown that patients with AAH, AIS and MIA have excellent survival rates (5-year survival rate is approximate 95%) after resection, and only 0.83% - 2.91% patients have lymph node metastasis [6-9]. At present, lymphadenectomy is always undergone in patients with pulmonary adenocarcinoma with ground-glass opacity. However, for MIA patients (especially in T1a-b stage), the appropriate use of lymphadenectomy continues to be debated.

Nowadays, intraoperative frozen pathology is widely used during operation. However, whether sampling of lymph nodes or lymphadenectomy should be performed for GGO lesions according to intraoperative pathological diagnosis is unclear. The aim of this prospective study is to evaluate whether there are any trends regarding the impact of subtypes of invasive adenocarcinoma according to intraoperative frozen pathology in sampling of lymph nodes vs. lymphadenectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 28, 2023
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. A peripheral nodular lesion;

2. The maximum diameters of whole GGO lesions and solid components on lung windows were no more than 3 cm (T1 stage);

3. VATS lobectomy

4. 25%?Consolidation/Tumor ratio ?50%

5. ECOG performance status 0-2;

6. Without distant metastasis;

7. Intraoperative frozen pathology confirmed invasive or minimally invasive adenocarcinoma.

8. No operation contraindication

9. Cardiovascular: Cardiac function normal

10. Renal: Creatinine clearance greater than 60 ml/min

11. The expected survival after surgery = 6 months

12. Must be able to sign written informed consent form

Exclusion Criteria:

1. Age less than 18 years old

2. Known hereditary bleeding disorder with history of post-operative hemorrhage

3. Patients maintained on chronic anticoagulation (eg Coumadin therapy)

4. Known hematogenous disorder

5. Known primary or secondary malignancy

6. Pregnant or breast-feeding women;

7. Clinically significant heart disease;

8. Patients who are unwilling or unable to comply with study procedures;

9. Receiving immunosuppressive therapy;

10. HIV/AIDS.

11. Multiple lesions in lung

Related Conditions & MeSH terms

• Adenocarcinoma
• Lymph Node Excision

Intervention

Procedure:
• systematic sampling of the lymph-node
Systematic Sampling of lymph nodes
• lymphadenectomy
Routine lymph nodes dissection in lung cancer

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China	Changhai Hospital, RenJi Hospital, Ruijin Hospital, Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Tsutani Y, Miyata Y, Nakayama H, Okumura S, Adachi S, Yoshimura M, Okada M. Appropriate sublobar resection choice for ground glass opacity-dominant clinical stage IA lung adenocarcinoma: wedge resection or segmentectomy. Chest. 2014 Jan;145(1):66-71. doi: — View Citation

Ye B, Cheng M, Li W, Ge XX, Geng JF, Feng J, Yang Y, Hu DZ. Predictive factors for lymph node metastasis in clinical stage IA lung adenocarcinoma. Ann Thorac Surg. 2014 Jul;98(1):217-23. doi: 10.1016/j.athoracsur.2014.03.005. Epub 2014 May 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence-free survival	recurrence-free survival status of patients after surgery	five years after surgery
Secondary	Overall Survival	survival status of patients after surgery	five years after surgery
Secondary	Morbidity rate	the rates of complications related to treatment during perioperative period	up to 30 days after surgery
Secondary	Mortality rate	the rates of death related to treatment during perioperative period	up to 30 days after surgery