NCT03720405

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

October 24, 2018

Last Update Submit

October 24, 2018

Conditions

Keywords

pulmonary resectionEsophageal segmentationRegression equation

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient from Department of Thoracic Surgery, Southern Hospital of Southern Medical University.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guandong, Guangdong, 510515, China

RECRUITING

Related Publications (11)

  • 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. No abstract available.

    PMID: 28111535BACKGROUND
  • 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.

    PMID: 27810391BACKGROUND
  • 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.

    PMID: 22552194BACKGROUND
  • 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.

    PMID: 28648400BACKGROUND
  • 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.

    PMID: 26576752BACKGROUND
  • Markar SR, Gronnier C, Duhamel A, Pasquer A, Thereaux 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.

    PMID: 26135681BACKGROUND
  • 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.

    PMID: 25454924BACKGROUND
  • 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.

    PMID: 23319427BACKGROUND
  • 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.

    PMID: 26391150BACKGROUND
  • 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.

    PMID: 24365211BACKGROUND
  • 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. doi: 10.1067/msy.2003.117.

    PMID: 12717351BACKGROUND

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2018

First Posted

October 25, 2018

Study Start

July 31, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations