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

Lung Cancer Clinical Trial

Official title:

Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer: A Multi-centre Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03436329
• Other study ID #: TSCI005
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2020
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Circulating Tumor Cell
• Lung Cancer
• Lung Neoplasms
• Neoplastic Cells, Circulating
• Surgery

Intervention

Procedure:
• Vein ligation first
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.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chendu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (11)

Ackerman NB. Primary arterial ligation in resection of cancer of the colon. Rational and technic. Am J Surg. 1977 Jan;133(1):73-7. — View 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. — View 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. Epub 2005 Dec 1. — View 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. — View 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. — View Citation

Kozak A, Alchimowicz J, Safranow K, Wójcik J, Kochanowski L, Kubisa B, Pieróg 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. — View 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. — View 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. — View 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. — View 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. Epub 2012 Nov 9. — View 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. Epub 2007 Feb 15. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3-year Progression-Free-Survival	From the date of recruitment until the date of progression of lung cancer assessed up to 36 months	From date of the recruitment, assessed up to 36 months
Secondary	Blood loss	Blood loss during the surgery	During the surgery
Secondary	Operative time	Operative time during the surgery	During the surgery
Secondary	Length of stay	The length of patients staying in hospital from the date of checking in to the date of checking out	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
Secondary	Morbidity	Complications resulting from surgery, such as pneumonia, air leak and arrhythmia.	Within 30 days after surgery