Oesophageal CancerNCT06662513
Post Oesophagectomy Outcomes in a Single Regional Centre in Australia
An observational study of Oesophageal Cancer, run by Launceston General Hospital at 1 site in Australia.
Trial summary
Literature review/rationale for project Oesophageal cancer is associated with a grim prognosis despite many advances in treatment. Oesophagectomy is a key component of the care of patients who are candidates for curative treatment, however it is associated with substantial morbidity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oesophageal Cancer
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Nov 2024to 30 Nov 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who underwent oeophagectomy at Launceston General Hospital between January 2014 to December 2023
Who may be able to join
- patients who underwent oeophagectomy at Launceston General Hospital between January 2014 to December 2023
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Launceston General Hospital
Launceston, Tasmania, 7250
Girish Pande, FRACS, 61+ 439 656 110, girish.pande@ths.tas.gov.au
Kevin Yoong, MBBS, 61+ 452 376 618, kevin.yoong@ths.tas.gov.au
About this study
Official title: An Australian Regional Hospital's Oesophagectomy Outcomes
Literature review/rationale for project
- Oesophageal cancer is associated with a grim prognosis despite many advances in treatment. Oesophagectomy is a key component of the care of patients who are candidates for curative treatment, however it is associated with substantial morbidity.
- Several studies have suggested that oesophagectomies performed at higher volume tertiary centres are associated with lower morbidity and mortality than lower volume centres, and this has prompted changes to policy in countries such as Great Britain, Canada and the Netherlands with regards to the centralisation of these cases. A higher volume centre within Australia is likely to perform 6 or more procedures per year.
- Currently within Australia, centralisation on a large scale has not occurred. This has been limited in part by resource provision and geographical barriers. Therefore, oesophagectomies in Australia are still routinely performed in regional centres. However, there is a paucity of recent outcomes data from these centres.
Read more
Aims/objectives
- Retrospective review of oesophagectomies undertaken in a single regional centre in Tasmania, Australia over 10 years (January 2014 to December 2023)
- Assess outcomes (long and short-term complications and mortality) and compare to morbidity and mortality rates from larger international centres
Read the detailed description
Research aims/objectives
- Retrospective review of oesophagectomies undertaken in a single regional centre in Tasmania, Australia over 10 years (January 2014 to December 2023)
- Assess outcomes (long and short-term complications, mortality, survival) and compare to published outcomes from larger national and international centres
Project Design Research project setting: Launceston General Hospital (Tasmania, Australia)
Methodological approach: Retrospective case series
Participants
- Retrospective identification of patients who underwent oesophagectomy at Launceston General Hospital from January 2014 to December 2023 via coding in medical records and MBS codes
- Inclusion criteria: patients who underwent oeosphagectomy at LGH in the specified time frame
- Exclusion criteria: none
- Expected size of case series is approximately 100 patients (this is extrapolated from the number of oesophagectomies performed in 2023)
Participant recruitment strategies and timeframes: No active participation of patients in this case series, all information will be retrospectively collected from medical records
Consent: Given the number of expected patients (approximately 100) and the potential distress that could be caused to patients or their next of kin in seeking consent, an Application for the Waiver of the requirement for Consent will be submitted
Research Activities
- No participant commitment is required
- Project duration is approximately 4 weeks for data collection, 4 weeks for analysis and writing
- No Participant follow-up is planned as part of this project
Data Collection/Gathering
- Data will be collected by assessment medical records only
- Only the PI will access identifying details such as name and date of birth.
- Information that will be collected includes: Patient demographics: age, gender, neoadjuvant treatment, co-morbidities, BMI, ASA score, type of oesophagectomy (2 or 3 stage). Primary endpoints: mortality (in hospital, 30 day and 90 day), anastomotic leak, length of stay (ICU, acute inpatient). Secondary endpoints: chyle leak, pneumonia, reintubation, return to theatre, wound infection, intra-abdominal infection, cardiac complications, DVT/PE, anastomotic stricture, diaphragmatic hernia, disease recurrence, survival
Data Management
- Data will be entered into an excel spreadsheet kept on a password protected THS computer in the department of surgery in LGH
- Data will only be accessed by the named investigators that are based at LGH (no external researcher will have access to data)
- There will be no hard copies of this data
- Data will not be transferred to personal computers/laptops
- Data will be destroyed/deleted by the PI 5 years after publication date
Data Analysis
- Outcomes will be calculated as percentages and then compared to published outcomes data from other Australian centres and international centres Examples of some published studies that may be used to compare outcomes are listed in citations.
- Given the retrospective nature of the data collection it is anticipated that some information will be missing however the kind of data the investigators plan to collect is very likely to be found in the medical record.
- Any missing information will be acknowledged when assessing results and the impact of the missing information will also be acknowledged when making any conclusions from those results
- Conditions
- Oesophageal Cancer
- Being tested
- No Intervention: Observational Cohort
- Keywords
- oesophageal cancer, regional surgery
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention - retrospective observational study
| Study group | Role | What they receive |
|---|---|---|
| oesophagectomy | patients who underwent oesophagectomy within the specified time frame Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
date of death from any cause or date of palliation whichever came first
Measured: from date of surgery to end of study (November 2024) for a timeframe up to 10 years
Anastomotic leak
Grade 1-3, diagnosed radiologicaly, requiring intervention (surgical or non-surgical)
Measured: from date of surgery to end of study period (Nov 2024), assessed up to 10 years
Length of stay
total inpatient hospital stay and total ICU length stay
Measured: from date of surgery to discharge date of hospital admission, approximately 2-4 weeks in most cases but assessed up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion14 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Launceston General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Tasmania
- Responsible party
- Principal investigator, Renishka Sellayah, Launceston General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662513
- Sponsor's protocol ID
- 2024/ETH01712
- Status last verified
- Nov 2024
- First submitted
- 21 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang AC. Centralizing Esophagectomy to Improve Outcomes and Enhance Clinical Research: Invited Expert Review. Ann Thorac Surg. 2018 Sep;106(3):916-923. doi: 10.1016/j.athoracsur.2018.04.004. Epub 2018 May 5.
PubMed 29738757Pu S, Chen H, Zhou C, Yu S, Liao X, Zhu L, He J, Wang B. Major Postoperative Complications in Esophageal Cancer After Minimally Invasive Esophagectomy Compared With Open Esophagectomy: An Updated Meta-analysis. J Surg Res. 2021 Jan;257:554-571. doi: 10.1016/j.jss.2020.08.011. Epub 2020 Sep 11.
PubMed 32927322De Silva I, Wee M, Cabalag CS, Fong R, Tran K, Wu M, Schloithe A, Bright T, Duong CP, Watson DI. Para-conduit diaphragmatic hernia following esophagectomy-the new price of minimally invasive surgery? Dis Esophagus. 2023 Apr 29;36(5):doad011. doi: 10.1093/dote/doad011.
PubMed 36912068Buchholz V, Hazard R, Lee DK, Liu DS, Zhang W, Chen S, Aly A, Barnett S, Le P, Weinberg L. Textbook outcomes after oesophagectomy: a single-centre observational study. BMC Surg. 2023 Dec 8;23(1):368. doi: 10.1186/s12893-023-02253-7.
PubMed 38066440Edmondson J, Hunter J, Bakis G, O'Connor A, Wood S, Qureshi AP. Understanding Post-Esophagectomy Complications and Their Management: The Early Complications. J Clin Med. 2023 Dec 11;12(24):7622. doi: 10.3390/jcm12247622.
PubMed 38137691Oesophago-Gastric Anastomosis Study Group on behalf of the West Midlands Research Collaborative. Comparison of short-term outcomes from the International Oesophago-Gastric Anastomosis Audit (OGAA), the Esophagectomy Complications Consensus Group (ECCG), and the Dutch Upper Gastrointestinal Cancer Audit (DUCA). BJS Open. 2021 May 7;5(3):zrab010. doi: 10.1093/bjsopen/zrab010.
PubMed 35179183Anderson O, Ni Z, Moller H, Coupland VH, Davies EA, Allum WH, Hanna GB. Hospital volume and survival in oesophagectomy and gastrectomy for cancer. Eur J Cancer. 2011 Nov;47(16):2408-14. doi: 10.1016/j.ejca.2011.07.001. Epub 2011 Aug 9.
PubMed 21835609Doran SLF, Digby MG, Green SV, Kelty CJ, Tamhankar AP. Risk factors for and treatment of anastomotic strictures after Ivor Lewis esophagectomy. Surg Endosc. 2024 Nov;38(11):6771-6777. doi: 10.1007/s00464-024-11150-w. Epub 2024 Aug 19.
PubMed 39160303
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Australian Regional Hospital's Oesophagectomy Outcomes
- ClinicalTrials.gov ID
- NCT06662513
- Acronym / sponsor ID
- 2024/ETH01712
- Conditions
- Oesophageal Cancer
- Keywords
- oesophageal cancer, regional surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Launceston General HospitalUniversity, hospital or other
- Collaborators
- Department of Health, Tasmania
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 14 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 29 Oct 2024 (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.
Literature review/rationale for project
- Oesophageal cancer is associated with a grim prognosis despite many advances in treatment. Oesophagectomy is a key component of the care of patients who are candidates for curative treatment, however it is associated with substantial morbidity.
- Several studies have suggested that oesophagectomies performed at higher volume tertiary centres are associated with lower morbidity and mortality than lower volume centres, and this has prompted changes to policy in countries such as Great Britain, Canada and the Netherlands with regards to the centralisation of these cases. A higher volume centre within Australia is likely to perform 6 or more procedures per year.
- Currently within Australia, centralisation on a large scale has not occurred. This has been limited in part by resource provision and geographical barriers. Therefore, oesophagectomies in Australia are still routinely performed in regional centres. However, there is a paucity of recent outcomes data from these centres.
Aims/objectives
- Retrospective review of oesophagectomies undertaken in a single regional centre in Tasmania, Australia over 10 years (January 2014 to December 2023)
- Assess outcomes (long and short-term complications and mortality) and compare to morbidity and mortality rates from larger international centres
Detailed description
Research aims/objectives
- Retrospective review of oesophagectomies undertaken in a single regional centre in Tasmania, Australia over 10 years (January 2014 to December 2023)
- Assess outcomes (long and short-term complications, mortality, survival) and compare to published outcomes from larger national and international centres
Project Design Research project setting: Launceston General Hospital (Tasmania, Australia)
Methodological approach: Retrospective case series
Participants
- Retrospective identification of patients who underwent oesophagectomy at Launceston General Hospital from January 2014 to December 2023 via coding in medical records and MBS codes
- Inclusion criteria: patients who underwent oeosphagectomy at LGH in the specified time frame
- Exclusion criteria: none
- Expected size of case series is approximately 100 patients (this is extrapolated from the number of oesophagectomies performed in 2023)
Participant recruitment strategies and timeframes: No active participation of patients in this case series, all information will be retrospectively collected from medical records
Consent: Given the number of expected patients (approximately 100) and the potential distress that could be caused to patients or their next of kin in seeking consent, an Application for the Waiver of the requirement for Consent will be submitted
Research Activities
- No participant commitment is required
- Project duration is approximately 4 weeks for data collection, 4 weeks for analysis and writing
- No Participant follow-up is planned as part of this project
Data Collection/Gathering
- Data will be collected by assessment medical records only
- Only the PI will access identifying details such as name and date of birth.
- Information that will be collected includes: Patient demographics: age, gender, neoadjuvant treatment, co-morbidities, BMI, ASA score, type of oesophagectomy (2 or 3 stage). Primary endpoints: mortality (in hospital, 30 day and 90 day), anastomotic leak, length of stay (ICU, acute inpatient). Secondary endpoints: chyle leak, pneumonia, reintubation, return to theatre, wound infection, intra-abdominal infection, cardiac complications, DVT/PE, anastomotic stricture, diaphragmatic hernia, disease recurrence, survival
Data Management
- Data will be entered into an excel spreadsheet kept on a password protected THS computer in the department of surgery in LGH
- Data will only be accessed by the named investigators that are based at LGH (no external researcher will have access to data)
- There will be no hard copies of this data
- Data will not be transferred to personal computers/laptops
- Data will be destroyed/deleted by the PI 5 years after publication date
Data Analysis
- Outcomes will be calculated as percentages and then compared to published outcomes data from other Australian centres and international centres Examples of some published studies that may be used to compare outcomes are listed in citations.
- Given the retrospective nature of the data collection it is anticipated that some information will be missing however the kind of data the investigators plan to collect is very likely to be found in the medical record.
- Any missing information will be acknowledged when assessing results and the impact of the missing information will also be acknowledged when making any conclusions from those results
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oesophagectomy | – | Other: No Intervention: Observational Cohortpatients who underwent oesophagectomy within the specified time frame |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who underwent oeophagectomy at Launceston General Hospital between January 2014 to December 2023
Key inclusion criteria (1 listed)
- patients who underwent oeophagectomy at Launceston General Hospital between January 2014 to December 2023
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo intervention - retrospective observational study | Other | oesophagectomy |
Primary outcome
mortality
Time frame: from date of surgery to end of study (November 2024) for a timeframe up to 10 years
date of death from any cause or date of palliation whichever came first
Anastomotic leak
Time frame: from date of surgery to end of study period (Nov 2024), assessed up to 10 years
Grade 1-3, diagnosed radiologicaly, requiring intervention (surgical or non-surgical)
Length of stay
Time frame: from date of surgery to discharge date of hospital admission, approximately 2-4 weeks in most cases but assessed up to 12 weeks
total inpatient hospital stay and total ICU length stay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Background: PubMed 29738757Chang AC. Centralizing Esophagectomy to Improve Outcomes and Enhance Clinical Research: Invited Expert Review. Ann Thorac Surg. 2018 Sep;106(3):916-923. doi: 10.1016/j.athoracsur.2018.04.004. Epub 2018 May 5.
- Background: PubMed 32927322Pu S, Chen H, Zhou C, Yu S, Liao X, Zhu L, He J, Wang B. Major Postoperative Complications in Esophageal Cancer After Minimally Invasive Esophagectomy Compared With Open Esophagectomy: An Updated Meta-analysis. J Surg Res. 2021 Jan;257:554-571. doi: 10.1016/j.jss.2020.08.011. Epub 2020 Sep 11.
- Background: PubMed 36912068De Silva I, Wee M, Cabalag CS, Fong R, Tran K, Wu M, Schloithe A, Bright T, Duong CP, Watson DI. Para-conduit diaphragmatic hernia following esophagectomy-the new price of minimally invasive surgery? Dis Esophagus. 2023 Apr 29;36(5):doad011. doi: 10.1093/dote/doad011.
- Background: PubMed 38066440Buchholz V, Hazard R, Lee DK, Liu DS, Zhang W, Chen S, Aly A, Barnett S, Le P, Weinberg L. Textbook outcomes after oesophagectomy: a single-centre observational study. BMC Surg. 2023 Dec 8;23(1):368. doi: 10.1186/s12893-023-02253-7.
- Background: PubMed 38137691Edmondson J, Hunter J, Bakis G, O'Connor A, Wood S, Qureshi AP. Understanding Post-Esophagectomy Complications and Their Management: The Early Complications. J Clin Med. 2023 Dec 11;12(24):7622. doi: 10.3390/jcm12247622.
- Background: PubMed 35179183Oesophago-Gastric Anastomosis Study Group on behalf of the West Midlands Research Collaborative. Comparison of short-term outcomes from the International Oesophago-Gastric Anastomosis Audit (OGAA), the Esophagectomy Complications Consensus Group (ECCG), and the Dutch Upper Gastrointestinal Cancer Audit (DUCA). BJS Open. 2021 May 7;5(3):zrab010. doi: 10.1093/bjsopen/zrab010.
- Background: PubMed 21835609Anderson O, Ni Z, Moller H, Coupland VH, Davies EA, Allum WH, Hanna GB. Hospital volume and survival in oesophagectomy and gastrectomy for cancer. Eur J Cancer. 2011 Nov;47(16):2408-14. doi: 10.1016/j.ejca.2011.07.001. Epub 2011 Aug 9.
- Background: PubMed 39160303Doran SLF, Digby MG, Green SV, Kelty CJ, Tamhankar AP. Risk factors for and treatment of anastomotic strictures after Ivor Lewis esophagectomy. Surg Endosc. 2024 Nov;38(11):6771-6777. doi: 10.1007/s00464-024-11150-w. Epub 2024 Aug 19.
- Individual participant dataSharing planned: No
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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.
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 Oesophageal Cancer, run by Launceston General Hospital at 1 site in Australia.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 5 Nov 2024. 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 Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renishka N Sellayah, MBBS (hons) FRACS (+61 425 816 462, r.sellayah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: from date of surgery to end of study (November 2024) for a timeframe up to 10 years). The study lists 3 primary outcomes in all. 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 NCT06662513, which also lists 8 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 5 Nov 2024.