NCT03322826

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 8, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2023

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

3.9 years

First QC Date

October 23, 2017

Last Update Submit

December 15, 2017

Conditions

Lymph Node Excision

Outcome Measures

Primary Outcomes (1)

  • recurrence-free survival

    recurrence-free survival status of patients after surgery

    five years after surgery

Secondary Outcomes (3)

  • Overall Survival

    five years after surgery

  • Morbidity rate

    up to 30 days after surgery

  • Mortality rate

    up to 30 days after surgery

Study Arms (2)

Lymphadenectomy

ACTIVE COMPARATOR

systematically Lymphadenectomy of the lymph-node stations ATS 2, 4, 7, 8, 9,10,11 on the right side and ATS 5, 6, 7, 8, 9,10,11 on the left side

Procedure: lymphadenectomy

systematic sampling of the lymph nodes

EXPERIMENTAL

systematic sampling of the lymph-node stations ATS 2, 4, 7, 8, 9,10,11 on the right side and ATS 5, 6, 7, 8, 9,10,11 on the left side

Procedure: systematic sampling of the lymph-node

Interventions

systematic sampling of the lymph-nodePROCEDURE

Systematic Sampling of lymph nodes

systematic sampling of the lymph nodes
lymphadenectomyPROCEDURE

Routine lymph nodes dissection in lung cancer

Lymphadenectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A peripheral nodular lesion;
  • The maximum diameters of whole GGO lesions and solid components on lung windows were no more than 3 cm (T1 stage);
  • VATS lobectomy
  • %≦Consolidation/Tumor ratio ≦50%
  • ECOG performance status 0-2;
  • Without distant metastasis;
  • Intraoperative frozen pathology confirmed invasive or minimally invasive adenocarcinoma.
  • No operation contraindication
  • Cardiovascular: Cardiac function normal
  • Renal: Creatinine clearance greater than 60 ml/min
  • The expected survival after surgery ≥ 6 months
  • Must be able to sign written informed consent form

You may not qualify if:

  • Age less than 18 years old
  • Known hereditary bleeding disorder with history of post-operative hemorrhage
  • Patients maintained on chronic anticoagulation (eg Coumadin therapy)
  • Known hematogenous disorder
  • Known primary or secondary malignancy
  • Pregnant or breast-feeding women;
  • Clinically significant heart disease;
  • Patients who are unwilling or unable to comply with study procedures;
  • Receiving immunosuppressive therapy;
  • HIV/AIDS.
  • Multiple lesions in lung

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related 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: 10.1378/chest.13-1094.

    PMID: 24551879RESULT

  • 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.

    PMID: 24841547RESULT

MeSH Terms

Interventions

Lymph Node Excision

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Chang Chen, M.D. Ph.D.

CONTACT

13816869003chenthoracic@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President

Study Record Dates

First Submitted

October 23, 2017

First Posted

October 26, 2017

Study Start

December 8, 2017

Primary Completion

October 28, 2021

Study Completion

October 28, 2023

Last Updated

December 19, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)