Oesophageal Cancer NosNCT06721715
Textbook Outcomes After Oesophagectomy in Regional Australia
An observational study of Oesophageal Cancer Nos, run by Launceston General Hospital at 1 site in Australia.
Trial summary
The goal of this observational cohort study is to assess textbook outcomes after oesophagectomy in a regional Australian hospital. This is a composite quality measure that include 9 parameters related to cancer care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oesophageal Cancer Nos
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2024to Dec 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: All patients who underwent oesophagectomy at a single regional hospital in Tasmania, Australia between January 2014 and December 2023 will be included in this study,
Who may be able to join
- all patients who underwent oesophagectomy between January 2014 and 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
About this study
Official title: Textbook Outcomes After Oesophagectomy in a Regional Australian Hospital: a Retrospective Observational Cohort Study
The goal of this observational cohort study is to assess textbook outcomes after oesophagectomy in a regional Australian hospital. This is a composite quality measure that include 9 parameters related to cancer care. Researchers will compares the textbook outcome rate in this regional hospital and compare it to textbook outcomes rates from other Australian hospitals, as well as hospitals overseas. Participants will not be actively involved in this study, as all data will be collected from medical records only.
Read the detailed description
Rationale Textbook outcomes is a composite tool to assess the quality of cancer care within an institution by evaluating several perioperative and postoperative factors. Most studies assessing textbook outcomes after oesophagectomy have been conducted in high-volume centres, achieving rates of up to 50%. To the best of our knowledge this is the first study to assess textbook outcomes after oesophagectomy in a regional Australian hospital, providing a unique insight into the performance of this procedure in a country that has not widely adopted centralisation of cases.
Aims/objectives To calculate textbook outcomes rates in a regional hospital in Australia and compare to higher volume Australian and international institutions.
Methods Retrospective identification of patients from MBS codes related to oesphagectomy, and collection of data retrospectively from the medical record only. All patients undergoing oesophagectomy from January 2014 to December 2023 will be included. There are no exclusion criteria.
Data collection Baseline patient characteristics, tumour-specific factors, textbook outcome parameters, treatment details including postoperative complications, and follow up data on survival will be collected
Statistical analysis Statistical analysis will be performed in consultation with a biostatistician. The number and proportion of patients who meet each parameter of the textbook outcome will be calculated for each year and compared. Patient characteristics (age, gender, BMI and ASA grade), tumour factors (histology, AJCC clinical T and N stage), and treatment aspects (neoadjuvant therapy and surgical approach) will be assessed for association with textbook outcomes using the Chi squared test with significance considered less than 0.05. A Kaplan-Meier survival curve will be used to investigate overall survival of patients with and without a textbook outcome.
- Conditions
- Oesophageal Cancer Nos
- Keywords
- oesophagectomy, 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.
| Study group | Role | What they receive |
|---|---|---|
| Textbook outcome | Patients that achieve a textbook outcome after oesophagectomy | |
| No textbook outcome | Patients who do not achieve a textbook outcome after oesophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Textbook outcome
Patients who achieve a textbook outcome. This is defined when all 9 following criteria are met: R0 resection, retrieval of 15 or more lymph nodes, no intraoperative complications, no post-operative complications Clavien-Dindo grade III or higher, no readmission to the ICU, no hospital stay longer than 21 days, no mortality within 90 days, no readmission related to the procedure within 30 days of admission, and no reintervention related to the surgical procedure (operative, endoscopic or radiologic).
Measured: from date of surgery to end of study (December 2024) for a timeframe up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Oesophageal Cancer NosStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Launceston General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renishka Sellayah, Launceston General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721715
- Sponsor's protocol ID
- 2024/STE03324
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalff MC, Vesseur I, Eshuis WJ, Heineman DJ, Daams F, van der Peet DL, van Berge Henegouwen MI, Gisbertz SS. The Association of Textbook Outcome and Long-Term Survival After Esophagectomy for Esophageal Cancer. Ann Thorac Surg. 2021 Oct;112(4):1134-1141. doi: 10.1016/j.athoracsur.2020.09.035. Epub 2020 Nov 19.
PubMed 33221197Kay B, Healy TE. Propofol ('Diprivan') for outpatient cystoscopy. Efficacy and recovery compared with althesin and methohexitone. Postgrad Med J. 1985;61 Suppl 3:108-14.
PubMed 3877277Kalff MC, van Berge Henegouwen MI, Gisbertz SS. Textbook outcome for esophageal cancer surgery: an international consensus-based update of a quality measure. Dis Esophagus. 2021 Jul 12;34(7):doab011. doi: 10.1093/dote/doab011.
PubMed 33744921Ball ED, Keefe KA, Colby E. Expression of antigens associated with small cell carcinoma of the lung on hematopoietic progenitor cells. Cancer Res. 1987 Dec 15;47(24 Pt 1):6556-9.
PubMed 2824035van der Werf LR, Wijnhoven BPL, Fransen LFC, van Sandick JW, Nieuwenhuijzen GAP, Busweiler LAD, van Hillegersberg R, Wouters MWJM, Luyer MDP, van Berge Henegouwen MI. A National Cohort Study Evaluating the Association Between Short-term Outcomes and Long-term Survival After Esophageal and Gastric Cancer Surgery. Ann Surg. 2019 Nov;270(5):868-876. doi: 10.1097/SLA.0000000000003520.
PubMed 31634182
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Textbook Outcomes After Oesophagectomy in a Regional Australian Hospital: a Retrospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06721715
- Acronym / sponsor ID
- 2024/STE03324
- Conditions
- Oesophageal Cancer Nos
- Keywords
- oesophagectomy, oesophageal cancer, regional surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Launceston General HospitalUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Dec 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.
The goal of this observational cohort study is to assess textbook outcomes after oesophagectomy in a regional Australian hospital. This is a composite quality measure that include 9 parameters related to cancer care. Researchers will compares the textbook outcome rate in this regional hospital and compare it to textbook outcomes rates from other Australian hospitals, as well as hospitals overseas. Participants will not be actively involved in this study, as all data will be collected from medical records only.
Detailed description
Rationale Textbook outcomes is a composite tool to assess the quality of cancer care within an institution by evaluating several perioperative and postoperative factors. Most studies assessing textbook outcomes after oesophagectomy have been conducted in high-volume centres, achieving rates of up to 50%. To the best of our knowledge this is the first study to assess textbook outcomes after oesophagectomy in a regional Australian hospital, providing a unique insight into the performance of this procedure in a country that has not widely adopted centralisation of cases.
Aims/objectives To calculate textbook outcomes rates in a regional hospital in Australia and compare to higher volume Australian and international institutions.
Methods Retrospective identification of patients from MBS codes related to oesphagectomy, and collection of data retrospectively from the medical record only. All patients undergoing oesophagectomy from January 2014 to December 2023 will be included. There are no exclusion criteria.
Data collection Baseline patient characteristics, tumour-specific factors, textbook outcome parameters, treatment details including postoperative complications, and follow up data on survival will be collected
Statistical analysis Statistical analysis will be performed in consultation with a biostatistician. The number and proportion of patients who meet each parameter of the textbook outcome will be calculated for each year and compared. Patient characteristics (age, gender, BMI and ASA grade), tumour factors (histology, AJCC clinical T and N stage), and treatment aspects (neoadjuvant therapy and surgical approach) will be assessed for association with textbook outcomes using the Chi squared test with significance considered less than 0.05. A Kaplan-Meier survival curve will be used to investigate overall survival of patients with and without a textbook outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Textbook outcome | – | –Patients that achieve a textbook outcome after oesophagectomy |
| No textbook outcome | – | –Patients who do not achieve a textbook outcome after oesophagectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent oesophagectomy at a single regional hospital in Tasmania, Australia between January 2014 and December 2023 will be included in this study,
Key inclusion criteria (1 listed)
- all patients who underwent oesophagectomy between January 2014 and 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.
Primary outcome
Textbook outcome
Time frame: from date of surgery to end of study (December 2024) for a timeframe up to 10 years
Patients who achieve a textbook outcome. This is defined when all 9 following criteria are met: R0 resection, retrieval of 15 or more lymph nodes, no intraoperative complications, no post-operative complications Clavien-Dindo grade III or higher, no readmission to the ICU, no hospital stay longer than 21 days, no mortality within 90 days, no readmission related to the procedure within 30 days of admission, and no reintervention related to the surgical procedure (operative, endoscopic or radiologic).
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 6 Dec 2024.
- Background: PubMed 33221197Kalff MC, Vesseur I, Eshuis WJ, Heineman DJ, Daams F, van der Peet DL, van Berge Henegouwen MI, Gisbertz SS. The Association of Textbook Outcome and Long-Term Survival After Esophagectomy for Esophageal Cancer. Ann Thorac Surg. 2021 Oct;112(4):1134-1141. doi: 10.1016/j.athoracsur.2020.09.035. Epub 2020 Nov 19.
- Background: PubMed 3877277Kay B, Healy TE. Propofol ('Diprivan') for outpatient cystoscopy. Efficacy and recovery compared with althesin and methohexitone. Postgrad Med J. 1985;61 Suppl 3:108-14.
- Background: PubMed 33744921Kalff MC, van Berge Henegouwen MI, Gisbertz SS. Textbook outcome for esophageal cancer surgery: an international consensus-based update of a quality measure. Dis Esophagus. 2021 Jul 12;34(7):doab011. doi: 10.1093/dote/doab011.
- Background: PubMed 2824035Ball ED, Keefe KA, Colby E. Expression of antigens associated with small cell carcinoma of the lung on hematopoietic progenitor cells. Cancer Res. 1987 Dec 15;47(24 Pt 1):6556-9.
- Background: PubMed 31634182van der Werf LR, Wijnhoven BPL, Fransen LFC, van Sandick JW, Nieuwenhuijzen GAP, Busweiler LAD, van Hillegersberg R, Wouters MWJM, Luyer MDP, van Berge Henegouwen MI. A National Cohort Study Evaluating the Association Between Short-term Outcomes and Long-term Survival After Esophageal and Gastric Cancer Surgery. Ann Surg. 2019 Nov;270(5):868-876. doi: 10.1097/SLA.0000000000003520.
- 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 Nos, 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 6 Dec 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 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?
Textbook outcome (time frame: from date of surgery to end of study (December 2024) for a timeframe up to 10 years). 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 NCT06721715, which also lists 5 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 6 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.