Back to resultsReduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer
Primary Purpose
Lung Cancer, Surgery, Circulating Tumor Cell
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Vein ligation first
Artery ligation first
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring Lung cancer, Surgical technique, vessel ligation, Circulating tumor cell
Eligibility Criteria
Inclusion Criteria:
- Patients with stage I-IV lung cancer eligible for surgery
- Patients undergoing the completely thoracoscopic lobectomy
- The nodule size was more than 2.5 cm
- Patients consenting for intraoperative blood sampling
Exclusion Criteria:
- Patients who underwent primary wedge resection and open lobectomy
- Patients who received neoadjuvant therapy before surgery
Sites / Locations
- West China Hospital, Sichuan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vein ligation first
Artery ligation first
Arm Description
During this procedure, patients undergo lobectomy with the pulmonary vein ligated first.
During this procedure, patients undergo lobectomy with the pulmonary artery ligated first.
Outcomes
Primary Outcome Measures
The changes of the level of circulating tumor cells in the peripheral blood
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
3-year Progression-Free-Survival
From the date of recruitment until the date of progression of lung cancer assessed up to 36 months
Blood loss
Blood loss during the surgery
Operative time
Operative time during the surgery
Length of stay
The length of patients staying in hospital from the date of checking in to the date of checking out
Morbidity
Complications resulting from surgery, such as pneumonia, air leak and arrhythmia.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03436329
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Surgery, Circulating Tumor Cell
Keywords
Lung cancer, Surgical technique, vessel ligation, Circulating tumor cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vein ligation first
Arm Type
Experimental
Arm Description
During this procedure, patients undergo lobectomy with the pulmonary vein ligated first.
Arm Title
Artery ligation first
Arm Type
Active Comparator
Arm Description
During this procedure, patients undergo lobectomy with the pulmonary artery ligated first.
Intervention Type
Procedure
Intervention Name(s)
Vein ligation first
Intervention Description
During this procedure, patients undergo lobectomy with the pulmonary vein ligated first.
Intervention Type
Procedure
Intervention Name(s)
Artery ligation first
Intervention Description
During this procedure, patients undergo lobectomy with the pulmonary artery ligated first.
Primary Outcome Measure Information:
Title
The changes of the level of circulating tumor cells in the peripheral blood
Description
The changes of the level of circulating tumor cells in the peripheral blood before cutting the skin and after closing the chest
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
3-year Progression-Free-Survival
Description
From the date of recruitment until the date of progression of lung cancer assessed up to 36 months
Time Frame
From date of the recruitment, assessed up to 36 months
Title
Blood loss
Description
Blood loss during the surgery
Time Frame
During the surgery
Title
Operative time
Description
Operative time during the surgery
Time Frame
During the surgery
Title
Length of stay
Description
The length of patients staying in hospital from the date of checking in to the date of checking out
Time Frame
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
Title
Morbidity
Description
Complications resulting from surgery, such as pneumonia, air leak and arrhythmia.
Time Frame
Within 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with stage I-IV lung cancer eligible for surgery
Patients undergoing the completely thoracoscopic lobectomy
The nodule size was more than 2.5 cm
Patients consenting for intraoperative blood sampling
Exclusion Criteria:
Patients who underwent primary wedge resection and open lobectomy
Patients who received neoadjuvant therapy before surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lunxu Liu, M.D.,Ph.D.
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital, Sichuan University
City
Chendu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24599353
Citation
Gall TM, Jacob J, Frampton AE, Krell J, Kyriakides C, Castellano L, Stebbing J, Jiao LR. Reduced dissemination of circulating tumor cells with no-touch isolation surgical technique in patients with pancreatic cancer. JAMA Surg. 2014 May;149(5):482-5. doi: 10.1001/jamasurg.2013.3643.
Results Reference
background
PubMed Identifier
7710337
Citation
Hansen E, Wolff N, Knuechel R, Ruschoff J, Hofstaedter F, Taeger K. Tumor cells in blood shed from the surgical field. Arch Surg. 1995 Apr;130(4):387-93. doi: 10.1001/archsurg.1995.01430040049007.
Results Reference
background
PubMed Identifier
26289504
Citation
Li F, Jiang G, Chen Y, Wang J. Curative Effects of Different Sequences of Vessel Interruption During the Completely Thoracoscopic Lobectomy on Early Stage Non-Small Cell Lung Cancer. Ann Thorac Cardiovasc Surg. 2015;21(6):536-43. doi: 10.5761/atcs.oa.15-00044. Epub 2015 Aug 18.
Results Reference
background
PubMed Identifier
23612700
Citation
Kozak A, Alchimowicz J, Safranow K, Wojcik J, Kochanowski L, Kubisa B, Pierog J, Grodzki T. The impact of the sequence of pulmonary vessel ligation during anatomic resection for lung cancer on long-term survival--a prospective randomized trial. Adv Med Sci. 2013;58(1):156-63. doi: 10.2478/v10039-012-0061-3.
Results Reference
background
PubMed Identifier
12830050
Citation
Refaely Y, Sadetzki S, Chetrit A, Simansky DA, Paley M, Modan B, Yellin A. The sequence of vessel interruption during lobectomy for non-small cell lung cancer: is it indeed important? J Thorac Cardiovasc Surg. 2003 Jun;125(6):1313-20. doi: 10.1016/s0022-5223(03)00022-9.
Results Reference
background
PubMed Identifier
9671904
Citation
Kurusu Y, Yamashita J, Hayashi N, Mita S, Fujino N, Ogawa M. The sequence of vessel ligation affects tumor release into the circulation. J Thorac Cardiovasc Surg. 1998 Jul;116(1):107-13. doi: 10.1016/s0022-5223(98)70248-x.
Results Reference
background
PubMed Identifier
16320073
Citation
Ge MJ, Shi D, Wu QC, Wang M, Li LB. Observation of circulating tumour cells in patients with non-small cell lung cancer by real-time fluorescent quantitative reverse transcriptase-polymerase chain reaction in peroperative period. J Cancer Res Clin Oncol. 2006 Apr;132(4):248-56. doi: 10.1007/s00432-005-0059-3. Epub 2005 Dec 1.
Results Reference
background
PubMed Identifier
17306554
Citation
Yellin A, Sadetzki S, Simansky DA, Refaely Y, Chetrit A, Paley M. The sequence of vessel interruption during lobectomy: does it affect the amount of blood retained in the lobe? Eur J Cardiothorac Surg. 2007 Apr;31(4):711-3. doi: 10.1016/j.ejcts.2007.01.019. Epub 2007 Feb 15.
Results Reference
background
PubMed Identifier
24618055
Citation
Hashimoto M, Tanaka F, Yoneda K, Takuwa T, Matsumoto S, Okumura Y, Kondo N, Tsubota N, Tsujimura T, Tabata C, Nakano T, Hasegawa S. Significant increase in circulating tumour cells in pulmonary venous blood during surgical manipulation in patients with primary lung cancer. Interact Cardiovasc Thorac Surg. 2014 Jun;18(6):775-83. doi: 10.1093/icvts/ivu048. Epub 2014 Mar 11.
Results Reference
background
PubMed Identifier
23420582
Citation
Song PP, Zhang W, Zhang B, Liu Q, DU J. Effects of different sequences of pulmonary artery and vein ligations during pulmonary lobectomy on blood micrometastasis of non-small cell lung cancer. Oncol Lett. 2013 Feb;5(2):463-468. doi: 10.3892/ol.2012.1022. Epub 2012 Nov 9.
Results Reference
background
PubMed Identifier
835783
Citation
Ackerman NB. Primary arterial ligation in resection of cancer of the colon. Rational and technic. Am J Surg. 1977 Jan;133(1):73-7. doi: 10.1016/0002-9610(77)90196-9.
Results Reference
background
PubMed Identifier
31042283
Citation
Wei S, Guo C, He J, Tan Q, Mei J, Yang Z, Liu C, Pu Q, Ma L, Yuan Y, Lin F, Zhu Y, Liao H, Wang W, Liu Z, Li Q, Jiang B, Li C, Xia L, Zhao K, Gan F, Cheng J, Wu Z, Wang Y, Lin Y, Kou Y, Che G, Chen L, Li J, Liu L. Effect of Vein-First vs Artery-First Surgical Technique on Circulating Tumor Cells and Survival in Patients With Non-Small Cell Lung Cancer: A Randomized Clinical Trial and Registry-Based Propensity Score Matching Analysis. JAMA Surg. 2019 Jul 1;154(7):e190972. doi: 10.1001/jamasurg.2019.0972. Epub 2019 Jul 17. Erratum In: JAMA Surg. 2019 Jun 12;:
Results Reference
derived
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Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer
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