Clinical trial NCT03436329: Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer
Official title: Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer: A Multi-centre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Surgery
Circulating Tumor Cell
Keywords: Lung cancer
Surgical technique
vessel ligation
Circulating tumor cell
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The changes of the level of circulating tumor cells in the peripheral blood
timeFrame: Intraoperative
Secondary outcomes:
measure: 3-year Progression-Free-Survival
timeFrame: From date of the recruitment, assessed up to 36 months
measure: Blood loss
timeFrame: During the surgery
measure: Operative time
timeFrame: During the surgery
measure: Length of stay
timeFrame: 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
measure: Morbidity
timeFrame: Within 30 days after surgery
Other outcomes:
Locations:
city: Chendu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Lunxu Liu, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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