Post Oesophagectomy Outcomes in a Single Regional Centre in Australia

NCT06662513 | Not Yet Recruiting

• 1 other identifier: 2024/ETH01712
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Oesophageal Cancer

Keywords

oesophageal cancer; regional surgery

Outcome Measures

Primary Outcomes (3)

• mortality

  date of death from any cause or date of palliation whichever came first

  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)

  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

  from date of surgery to discharge date of hospital admission, approximately 2-4 weeks in most cases but assessed up to 12 weeks

Study Arms (1)

oesophagectomy

patients who underwent oesophagectomy within the specified time frame

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No intervention - retrospective observational study

oesophagectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who underwent oeophagectomy at Launceston General Hospital between January 2014 to December 2023

You may qualify if:

• patients who underwent oeophagectomy at Launceston General Hospital between January 2014 to December 2023

You may not qualify if:

• none

Sponsors & Collaborators

• Launceston General Hospital: lead
• Department of Health, Tasmania: collaborator

Study Sites (1)

Launceston General Hospital

Launceston, Tasmania, 7250, Australia

Location

Related Publications (8)

• 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.

  PMID: 29738757 BACKGROUND

• 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.

  PMID: 32927322 BACKGROUND

• 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.

  PMID: 36912068 BACKGROUND

• 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.

  PMID: 38066440 BACKGROUND

• 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.

  PMID: 38137691 BACKGROUND

• 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.

  PMID: 35179183 BACKGROUND

• 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.

  PMID: 21835609 BACKGROUND

• 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 Nov;38(11):6771-6777. doi: 10.1007/s00464-024-11150-w. Epub 2024 Aug 19.

  PMID: 39160303 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Renishka N Sellayah, MBBS (hons) FRACS

CONTACT

+61 425 816 462; r.sellayah@gmail.com

Girish Pande, FRACS

CONTACT

+61 439 656 110; girish.pande@ths.tas.gov.au

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 29, 2024
• Study Start: November 1, 2024
• Primary Completion: November 14, 2024
• Study Completion: November 30, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)