Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer

Sponsor
West China Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03436329
Collaborator
(none)
60
1
2
49
1.2

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the impact of the sequence of vessel interruption in lung cancer patients on tumor cell spread and patient survival by using peripheral blood circulating tumor cells.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Vein ligation first
  • Procedure: Artery ligation first
N/A

Detailed Description

Circulating tumor cells (CTCs) in the peripheral blood can be a biomarker to predict tumor recurrence and survival. Handling the tumor during a surgery may promote the release of CTCs into the bloodstream. Therefore, in a surgery of cancer, interruption of the vein before ligation of the artery may be justified. This multi-center randomized controlled trial is to assess the impact of the sequence of vessel interruption in lung cancer patients on tumor cell spread and patient survival by using peripheral blood CTCs.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer: A Multi-centre Randomized Controlled Trial
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
May 31, 2018
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vein ligation first

During this procedure, patients undergo lobectomy with the pulmonary vein ligated first.

Procedure: Vein ligation first
During this procedure, patients undergo lobectomy with the pulmonary vein ligated first.

Active Comparator: Artery ligation first

During this procedure, patients undergo lobectomy with the pulmonary artery ligated first.

Procedure: Artery ligation first
During this procedure, patients undergo lobectomy with the pulmonary artery ligated first.

Outcome Measures

Primary Outcome Measures

  1. The changes of the level of circulating tumor cells in the peripheral blood [Intraoperative]

    The changes of the level of circulating tumor cells in the peripheral blood before cutting the skin and after closing the chest

Secondary Outcome Measures

  1. 3-year Progression-Free-Survival [From date of the recruitment, assessed up to 36 months]

    From the date of recruitment until the date of progression of lung cancer assessed up to 36 months

  2. Blood loss [During the surgery]

    Blood loss during the surgery

  3. Operative time [During the surgery]

    Operative time during the surgery

  4. Length of stay [From date of admission until the date of discharging or date of death from any cause in hospital, whichever came first, assessed up to 30 days]

    The length of patients staying in hospital from the date of checking in to the date of checking out

  5. Morbidity [Within 30 days after surgery]

    Complications resulting from surgery, such as pneumonia, air leak and arrhythmia.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patients with stage I-IV lung cancer eligible for surgery

  2. Patients undergoing the completely thoracoscopic lobectomy

  3. The nodule size was more than 2.5 cm

  4. Patients consenting for intraoperative blood sampling

Exclusion Criteria:
  1. Patients who underwent primary wedge resection and open lobectomy

  2. Patients who received neoadjuvant therapy before surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 West China Hospital, Sichuan University Chendu Sichuan China 610041

Sponsors and Collaborators

  • West China Hospital

Investigators

  • Principal Investigator: Lunxu Liu, M.D.,Ph.D., West China Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Lunxu Liu, Professor, West China Hospital
ClinicalTrials.gov Identifier:
NCT03436329
Other Study ID Numbers:
  • TSCI005
First Posted:
Feb 19, 2018
Last Update Posted:
Oct 12, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lunxu Liu, Professor, West China Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2020