Pulmonary ResectionNCT03720405
Measurement of the Distance Between the Corresponding Anatomical Landmarks in the Thoracic Cavity and the Incisors
An observational study of Pulmonary Resection, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Resection
- How many people
- 520 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2018to Dec 2019
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient from Department of Thoracic Surgery, Southern Hospital of Southern Medical University.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guandong, Guangdong, 510515
Di Lu, MD, PhD, 86+13268379321, david_lu189@163.com
Siyang Feng, MD, 86+13570930671, fengsy89@163.com
About this study
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.
- Conditions
- Pulmonary Resection
- Keywords
- pulmonary resection, Esophageal segmentation, Regression equation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start31 Jul 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pulmonary ResectionStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 520 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720405
- Sponsor's protocol ID
- NFEC-2018-85
- Status last verified
- Oct 2018
- First submitted
- 24 Oct 2018
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results of distance measurement of each individual participant.
Publications
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.
PubMed 28111535Rice 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.
PubMed 27810391Biere 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.
PubMed 22552194Lagergren 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.
PubMed 28648400Javidfar 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.
PubMed 26576752Markar 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.
PubMed 26135681Gilbert 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.
PubMed 25454924Chan 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.
PubMed 23319427Okada 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.
PubMed 26391150Wu 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.
PubMed 24365211Korn 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.
PubMed 12717351
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Distance Between the Corresponding Anatomical Landmarks in the Thoracic Cavity and the Incisors
- ClinicalTrials.gov ID
- NCT03720405
- Acronym / sponsor ID
- NFEC-2018-85
- Conditions
- Pulmonary Resection
- Keywords
- pulmonary resection, Esophageal segmentation, Regression equation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient from Department of Thoracic Surgery, Southern Hospital of Southern Medical University.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the distance from the incisors to the corresponding anatomical landmarks
Time frame: 1 hour
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Background: PubMed 28111535Japan 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.
- Background: PubMed 27810391Rice 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.
- Background: PubMed 22552194Biere 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.
- Background: PubMed 28648400Lagergren 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.
- Background: PubMed 26576752Javidfar 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.
- Background: PubMed 26135681Markar 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.
- Background: PubMed 25454924Gilbert 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.
- Background: PubMed 23319427Chan 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.
- Background: PubMed 26391150Okada 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.
- Background: PubMed 24365211Wu 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.
- Background: PubMed 12717351Korn 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.
- Individual participant dataSharing planned: Undecided. The results of distance measurement of each individual participant.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Resection, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Di Lu, MD,PhD (86+13268379321, david_lu1989@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the distance from the incisors to the corresponding anatomical landmarks (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03720405, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.