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

NCT ID: NCT03436329

Last Updated: 2020-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer Surgery Circulating Tumor Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Vein ligation first

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

Group Type EXPERIMENTAL

Vein ligation first

Intervention Type PROCEDURE

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

Artery ligation first

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

Group Type ACTIVE_COMPARATOR

Artery ligation first

Intervention Type PROCEDURE

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

Interventions

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Vein ligation first

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

Intervention Type PROCEDURE

Artery ligation first

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lunxu Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lunxu Liu, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

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West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 24599353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7710337 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26289504 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23612700 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12830050 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9671904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16320073 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17306554 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24618055 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23420582 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 835783 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31042283 (View on PubMed)

Other Identifiers

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TSCI005

Identifier Type: -

Identifier Source: org_study_id

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