Measurement of the Distance Between the Corresponding Anatomical Landmarks in the Thoracic Cavity and the Incisors

Pulmonary Resection Clinical Trial

Official title:

Measurement of the Distance Between the Corresponding Anatomical Landmarks in the Thoracic Cavity and the Incisors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03720405
• Other study ID #: NFEC-2018-85
• Status: Recruiting
• Start date: July 31, 2018
• Est. completion date: December 2019

Study information

• Verified date: October 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: Di Lu, MD,PhD
• Phone: 86+13268379321
• Email: david_lu1989[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Patients who agree to receive pneumonectomy will be arranged to measure the distance from the incisors to the corresponding anatomical landmarks, including the cardia, the inferior pulmonary vein, the carina, the azygos vein, the lower edge of the aortic arch, the upper edge of the aortic arch, and the cupula of pleura through " fiber measurement method within nasogastric tube " . After building regression equations with the above data, the distance from the incisors to these corresponding anatomical landmarks could be inferred by means of indexes including height and so on.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing thoracic operation(such as radical lung cancer resection, pulmonary lobectomy, pulmonary segmentectomy, etc.) under endotracheal anesthesia ,which can expose the corresponding anatomical landmarks;

• Patients undergoing nasogastric intubation due to their condition.

Exclusion Criteria:

• Patients with diseased or deformed esophagus;

• Patients with obvious thoracic deformity, spinal deformity or dysplasia;

• Patients whose thoracic anatomical landmarks can not be exposed or exposed clearly during operation;

• Patients who do not agree to be measured.

Related Conditions & MeSH terms

• Pulmonary Resection

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guandong	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (11)

Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1. — View Citation

Chan DS, Reid TD, Howell I, Lewis WG. Systematic review and meta-analysis of the influence of circumferential resection margin involvement on survival in patients with operable oesophageal cancer. Br J Surg. 2013 Mar;100(4):456-64. doi: 10.1002/bjs.9015. Epub 2013 Jan 14. Review. — View Citation

Gilbert S, Martel AB, Seely AJ, Maziak DE, Shamji FM, Sundaresan SR, Villeneuve PJ. Prognostic significance of a positive radial margin after esophageal cancer resection. J Thorac Cardiovasc Surg. 2015 Feb;149(2):548-55; discussion 555. doi: 10.1016/j.jtcvs.2014.10.040. Epub 2014 Oct 14. — View Citation

Japan Esophageal Society. Japanese Classification of Esophageal Cancer, 11th Edition: part I. Esophagus. 2017;14(1):1-36. doi: 10.1007/s10388-016-0551-7. Epub 2016 Nov 10. — View Citation

Javidfar J, Speicher PJ, Hartwig MG, D'Amico TA, Berry MF. Impact of Positive Margins on Survival in Patients Undergoing Esophagogastrectomy for Esophageal Cancer. Ann Thorac Surg. 2016 Mar;101(3):1060-7. doi: 10.1016/j.athoracsur.2015.09.005. Epub 2015 Nov 11. — View Citation

Korn O, Csendes A, Burdiles P, Braghetto I, Sagastume H, Biagini L. Length of the esophagus in patients with gastroesophageal reflux disease and Barrett's esophagus compared to controls. Surgery. 2003 Apr;133(4):358-63. — View Citation

Lagergren J, Smyth E, Cunningham D, Lagergren P. Oesophageal cancer. Lancet. 2017 Nov 25;390(10110):2383-2396. doi: 10.1016/S0140-6736(17)31462-9. Epub 2017 Jun 22. Review. — View Citation

Markar SR, Gronnier C, Duhamel A, Pasquer A, Théreaux J, Chalret du Rieu M, Lefevre JH, Turner K, Luc G, Mariette C; FREGAT Working Group-FRENCH-AFC. Significance of Microscopically Incomplete Resection Margin After Esophagectomy for Esophageal Cancer. Ann Surg. 2016 Apr;263(4):712-8. doi: 10.1097/SLA.0000000000001325. — View Citation

Okada N, Fujii S, Fujita T, Kanamori J, Kojima T, Hayashi R, Daiko H. The prognostic significance of the positive circumferential resection margin in pathologic T3 squamous cell carcinoma of the esophagus with or without neoadjuvant chemotherapy. Surgery. 2016 Feb;159(2):441-50. doi: 10.1016/j.surg.2015.06.044. Epub 2015 Sep 19. — View Citation

Rice TW, Ishwaran H, Ferguson MK, Blackstone EH, Goldstraw P. Cancer of the Esophagus and Esophagogastric Junction: An Eighth Edition Staging Primer. J Thorac Oncol. 2017 Jan;12(1):36-42. doi: 10.1016/j.jtho.2016.10.016. Epub 2016 Oct 31. — View Citation

Wu J, Chen QX, Teng LS, Krasna MJ. Prognostic significance of positive circumferential resection margin in esophageal cancer: a systematic review and meta-analysis. Ann Thorac Surg. 2014 Feb;97(2):446-53. doi: 10.1016/j.athoracsur.2013.10.043. Epub 2013 Dec 21. Review. — 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 distance from the incisors to the corresponding anatomical landmarks	The distance from the thoracic anatomical landmarks (the lower edge of the cardia, the inferior pulmonary vein, the condyle, the lower edge of the azygous vein, the lower edge of the aortic arch, the upper edge of the aortic arch, and the pleural apex) to the incisors.	1 hour