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Status unknownNCT03436329Updated Oct 12, 2020

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

An interventional study of Vein ligation first and Artery ligation first in Lung Cancer, Surgery and Circulating Tumor Cell, sponsored by West China Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-10-12.

Sponsored by West China Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer
  • Surgery
  • Circulating Tumor Cell

Keywords

  • Lung cancer
  • Surgical technique
  • vessel ligation
  • Circulating tumor cell
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

Exclusion Criteria:

  1. Patients who underwent primary wedge resection and open lobectomy
  2. Patients who received neoadjuvant therapy before surgery
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Vein ligation first

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

    Procedure: Vein ligation first

  • Active comparator
    Artery ligation first

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

    Procedure: Artery ligation first

Interventions

  • ProcedureVein ligation first

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

  • ProcedureArtery ligation first

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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Intraoperative

Secondary outcomes

  1. 3-year Progression-Free-Survival

    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

  2. Blood loss

    Blood loss during the surgery

    Time frame: During the surgery

  3. Operative time

    Operative time during the surgery

    Time frame: During the surgery

  4. Length of stay

    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

  5. Morbidity

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

    Time frame: Within 30 days after surgery

06

Study locations

1 site
  • West China Hospital, Sichuan University
    Chendu, Sichuan 610041, China
07

References and documents

Publications

  • 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. PubMed 24599353 ↗
  • 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. PubMed 7710337 ↗
  • 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. PubMed 26289504 ↗
  • 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. PubMed 23612700 ↗
  • 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. PubMed 12830050 ↗
  • 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. PubMed 9671904 ↗
  • 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. PubMed 16320073 ↗
  • 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. PubMed 17306554 ↗
  • 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. PubMed 24618055 ↗
  • 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. PubMed 23420582 ↗
  • 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. PubMed 835783 ↗
  • 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 Jul 1;154(7):676. doi: 10.1001/jamasurg.2019.2035. PubMed 31042283 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03436329
Lead sponsor
West China Hospital
Responsible party
Lunxu Liu (Professor, West China Hospital) — Principal investigator
First posted
Feb 19, 2018
Start date
Dec 1, 2016
Primary completion
May 31, 2018
Completion
Dec 31, 2020 (estimated)
Last update
Oct 12, 2020

Study contacts

Lunxu Liu, M.D.,Ph.D.
principal investigator · West China Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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