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

NCT03436329 | Unknown

• 1 other identifier: TSCI005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Surgery; Circulating Tumor Cell

Keywords

Lung cancer; Surgical technique; vessel ligation; Circulating tumor cell

Outcome Measures

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

  Intraoperative

Secondary Outcomes (5)

• 3-year Progression-Free-Survival

  From date of the recruitment, assessed up to 36 months

• Blood loss

  During the surgery

• Operative time

  During the surgery

• 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

• Morbidity

  Within 30 days after surgery

Study Arms (2)

Vein ligation first

EXPERIMENTAL

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

Procedure: Vein ligation first

Artery ligation first

ACTIVE COMPARATOR

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

Procedure: Artery ligation first

Interventions

Vein ligation first PROCEDURE

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

Vein ligation first

Artery ligation first PROCEDURE

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

Artery ligation first

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who underwent primary wedge resection and open lobectomy
• Patients who received neoadjuvant therapy before surgery

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (12)

• 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.

  PMID: 24599353 BACKGROUND

• 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.

  PMID: 7710337 BACKGROUND

• 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.

  PMID: 26289504 BACKGROUND

• 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.

  PMID: 23612700 BACKGROUND

• 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.

  PMID: 12830050 BACKGROUND

• 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.

  PMID: 9671904 BACKGROUND

• 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.

  PMID: 16320073 BACKGROUND

• 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.

  PMID: 17306554 BACKGROUND

• 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.

  PMID: 24618055 BACKGROUND

• 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.

  PMID: 23420582 BACKGROUND

• 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.

  PMID: 835783 BACKGROUND

• 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.

  PMID: 31042283 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lunxu Liu, M.D.,Ph.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 19, 2018
• Study Start: December 1, 2016
• Primary Completion: May 31, 2018
• Study Completion: December 31, 2020
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)