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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06662513




Registration number
NCT06662513
Ethics application status
Date submitted
21/10/2024
Date registered
29/10/2024
Date last updated
5/11/2024

Titles & IDs
Public title
Post Oesophagectomy Outcomes in a Single Regional Centre in Australia
Scientific title
An Australian Regional Hospital's Oesophagectomy Outcomes
Secondary ID [1] 0 0
2024/ETH01712
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oesophageal Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No Intervention: Observational Cohort

oesophagectomy - patients who underwent oesophagectomy within the specified time frame


Other interventions: No Intervention: Observational Cohort
No intervention - retrospective observational study
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
mortality
Timepoint [1] 0 0
from date of surgery to end of study (November 2024) for a timeframe up to 10 years
Primary outcome [2] 0 0
Anastomotic leak
Timepoint [2] 0 0
from date of surgery to end of study period (Nov 2024), assessed up to 10 years
Primary outcome [3] 0 0
Length of stay
Timepoint [3] 0 0
from date of surgery to discharge date of hospital admission, approximately 2-4 weeks in most cases but assessed up to 12 weeks

Eligibility
Key inclusion criteria
* patients who underwent oeophagectomy at Launceston General Hospital between January 2014 to December 2023
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* none

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 0 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 0 0
7250 - Launceston

Funding & Sponsors
Primary sponsor type
Other
Name
Launceston General Hospital
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Department of Health, Tasmania
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
* 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
Trial website
https://clinicaltrials.gov/study/NCT06662513
Trial related presentations / 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.
Pu 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.
De 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.
Buchholz 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.
Edmondson 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.
Oesophago-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. Erratum In: BJS Open. 2022 Jan 6;6(1):zrac027. doi: 10.1093/bjsopen/zrac027.
Anderson 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.
Doran SLF, Digby MG, Green SV, Kelty CJ, Tamhankar AP. Risk factors for and treatment of anastomotic strictures after Ivor Lewis esophagectomy. Surg Endosc. 2024 Aug 19. doi: 10.1007/s00464-024-11150-w. Online ahead of print.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Renishka N Sellayah, MBBS (hons) FRACS
Address 0 0
Country 0 0
Phone 0 0
+61 425 816 462
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06662513