NCT07022652

Brief Summary

The effect of centralisation measures on the operative outcomes after oesophageal cancer resection (ECR) in Switzerland has not been highlighted yet. Oesophageal cancer is a rare malignancy in Switzerland. It accounts for 2% of all cancers, with an incidence of 603 per year between 2017 and 2021, affecting primarily men (incidence per year 445, 74%). The mortality of oesophageal cancer is high. The 437 annual oesophageal cancer-related deaths between 2017 and 2021 result in a low 5-year overall survival (OS) of only 30%. Together with the often polymorbid patients, the very demanding surgical technique, and the challenges in postoperative management, a specialised, high-volume, interdisciplinary treatment team is required. The centralisation of such complex surgical procedures in specialised centres aims to build up such treatment teams, resulting in improved quality of the treatment and increased patient safety. To concentrate such procedures in Switzerland, the "Intercantonal agreement on highly specialized medicine" came into force in 2009. In 2013, esophagectomy was regulated for the first time, and the first service allocations were awarded definitely to eight and provisionally to another eight Swiss centres. Before 2013, esophagectomy was performed in 69 hospitals in Switzerland. The decision on the allocation was revised in 2019, resulting in only eight Swiss centres remaining with a service contract for esophagectomy. The next review will take place on the 31st of July 2025. This retrospective registry study provides Swiss national data on the effect of centralisation on operative outcomes after oesophageal cancer resection (ECR) in Switzerland. It aims to measure the influence of the hospital-specific case number of ECR per year (hospital volume) on the outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,880

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

10 years

First QC Date

May 26, 2025

Last Update Submit

June 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    The association between the hospital volume and the postoperative mortality Mortality Yes or No Hospital volume of esophageal cancer resection as marginal effect Association with GAM logistic regression

    Periprocedural

Secondary Outcomes (3)

  • Reoperation rate

    Periprocedural

  • Length of hospital stay

    Periprocedural

  • Sociodemographic trends

    2013 - 2022

Interventions

Esophageal cancer resection

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with esophageal cancer resection in Switzerland between 2013 and 2022

You may qualify if:

  • Esophageal cancer resection

You may not qualify if:

  • Incomplete documentation
  • Age under 20 years
  • Other hospitals than general or surgical hospitals
  • No index operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HOCH Health Ostschweiz, Kantonsspital St.Gallen

Sankt Gallen, St.Gallen, 9000, Switzerland

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 26, 2025

First Posted

June 15, 2025

Study Start

January 1, 2013

Primary Completion

December 31, 2022

Study Completion

May 15, 2025

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations