Centralization and Quality Control in Esophageal Cancer Surgery: a Way Forward in Europe

Esophageal cancer surgery involves highly complex surgical procedures, which may be associated with substantial morbidity and even mortality. Over the last decades, incremental advancements have been made through minimally invasive techniques and early rehabilitation after surgery (ERAS) protocols.^1–3 However, these improvements are not uniformly implemented across all European countries, and opportunities for further quality enhancement still exist. Two such opportunities are the centralization of esophageal cancer surgical care and quality control through national clinical audits. Although these initiatives face numerous organizational and structural obstacles and are entangled in political dynamics, both deserve further exploration in the pursuit of improving the outcome of esophageal cancer surgery throughout Europe.

CENTRALIZATION OF ESOPHAGEAL CANCER SURGICAL CARE

Currently, there are two main forms of centralization present in Europe: (i) centralization in dedicated centers, appointed by the government; and (ii) centralization through volume thresholds, to which centers must comply to perform esophageal cancer surgery. A recent study showed an uneven implementation of centralization across Europe.⁴ Both centralization strategies offer control over the number of centers, and subsequently over the annual volume per center.

The volume-outcome relationship has been well documented for esophageal cancer surgery and is believed to be an important driver of outcome improvement. A meta-analysis consisting of studies between 2000 and 2011, including only patients operated on since 2000, reported a significant decrease in in-hospital mortality (2.82% vs. 8.48%) and 30-day mortality (0.73% vs. 2.09%) in high-volume compared to low-volume esophagectomy centers.⁵ Another meta-analysis by Wouters et al. also showed a long-term survival benefit in high-volume centers.⁶ However, in both meta-analyses, the low- and high-volume categories ranged significantly. Several studies identified inferior results in low-volume centers when implementing a volume threshold of 20.^7–9 However, studies investigating the volume threshold at which outcome improvements stabilize are limited. Studies from the Netherlands showed improving outcomes (mortality, anastomotic leakage, lymph node yield, textbook outcome, and 6-month and 2-year survival) with increasing annual procedures, plateauing around 40–60 esophagectomies per year, with anastomotic leakage rates, and lymph node yield improving beyond 60 per year.^10,11 These results imply that a minimum volume threshold is greatly beneficial and that a threshold of 20 could be seen as a reasonable minimum, but also that further improvement can be achieved with at least 40–60 esophagectomies per year per center.

Combining volume thresholds for esophageal and gastric resections is also an attractive option, given the technical and therapeutic similarities between these procedures. This option has already been executed in the UK, where upper GI units need to fulfill volume criteria for esophagogastric surgery, including the care of a population of at least 1.2 million, through a 24/7 service with at least four dedicated upper GI surgeons. A harmonization of these norms is possible, especially in regions where the same surgical teams manage both types of surgeries. This not only ensures a high level of specialized care but can also streamline resources and expertise. It allows to build specialized care units with specialized pathways, including multidisciplinary medical specialties as well as nurses, dieticians, and physiotherapists. Concentration in centers that fully organize a care pathway around the diagnosis and treatment of esophageal and gastric cancer patients optimizes the quality of decision-making and accelerates the start of treatment. Additionally, it will result in reduced variation in the treatment of cancer across hospitals.¹² In its ambition to improve the quality of care while controlling the increasing cost of healthcare in the Netherlands, the Ministry of Health is pushing toward increasing volume thresholds for all complex surgical procedures, including esophagogastric cancer surgery (75–100/year).¹³

In addition to the increased experience in the initial surgical procedure, a clinical care team is available for the 24/7 management of postoperative complications and gains crucial experience in the management of other gastro-esophageal emergencies, such as Boerhaave syndrome or caustic ingestion. High-volume centers are suggested to have lower failure-to-rescue rates by being more capable of effectively managing complications, thereby averting a fatal outcome.^14,15 Besides the surgical expertise, it is thought that ‘hospital resources’, like the 24/7 availability of interventional radiology, experienced ICU staff, and anesthesiologists experienced in complex gastrointestinal surgery, significantly contribute to the improved outcomes in high-volume centers.^16,17 These essential resources can be required in clinical care standards for esophagectomy centers. Although performing high volumes is not the sole factor for improved outcomes, the higher number of procedures enhances proficiency in these complex surgical procedures for the whole clinical care team. In this respect, the concept of surgeon volume, while relevant, requires a cautious approach and is not supported by the authors. We advocate focusing on team performance over individual surgeon volume. This stance acknowledges the pressures on young surgeons and the potential misrepresentation of experienced surgeons handling more complex cases, and underscores the importance of evaluating the entire care pathway within a center rather than isolated metrics. Therefore, surgeon volume was purposefully left out of the Dutch Upper Gastrointestinal Cancer Audit (DUCA) in the Netherlands.

The focus on centralization also extends to specific patient cohorts and intricate procedures such as colon interpositions and salvage surgeries. These procedures are associated with higher morbidity and mortality rates compared to standard esophagectomy and are believed to benefit greatly from further centralization in expert centers.¹⁸ Subsequently, it also allows for efficient research with uniform protocols and high inclusion.

Mandating volume norms is a delicate subject. The Dutch model, guided by the Dutch Surgical Society and healthcare insurers, offers a blueprint. It emphasizes transparency and accountability, with a unique role of the Surgical Society and insurers in the Netherlands in yearly monitoring and enforcing these norms. In conjunction with volume, centers must adhere to stringent criteria, including SONCOS¹⁹ norms, to ensure high-quality care. However, there is no one-size-fits-all solution for all countries due to the diverse healthcare systems across Europe.

QUALITY CONTROL IN ESOPHAGEAL CANCER SURGICAL CARE

The other critical element that should accompany centralization is quality control. Mandatory national clinical audits play a pivotal role in this, offering a structured framework to monitor, evaluate, and enhance care quality. Multiple countries have reported the positive effects of their audits since inception.^20–22

In a structured auditing process, hospitals are provided annually with their results to induce the feedback loop needed for quality improvement. When hospitals consistently underperform the national benchmark, enforcement becomes a key factor, potentially leading to warnings and inspections by the auditing entity or the Society of Surgeons.

In the Netherlands, hospital results in multiple quality indicators are published openly every year, providing transparency and accountability to induce quality improvement. Similar regulations are present in Denmark, Sweden, Switzerland, and UK.⁴ Another route to induce quality improvement through audit data is through yearly best-practice meetings among surgeons to openly discuss outcomes. Since starting in 2018, it is suggested to have contributed to declining anastomotic leakage rates in the Netherlands.¹⁰

The foundation of robust clinical auditing lies in the comprehensive registration of care quality. This involves an extensive dataset capturing a range of variables, not only focusing on procedural aspects but also encompassing outcomes, such as 90-day mortality and, where possible, long-term survival rates. Complications should be registered according to the Esophageal (and Gastric) Complication Consensus Group guidelines to ensure accurate international comparisons.^23,24

The potential for automatic registration from electronic patient records or other data sources to minimize administrative burdens should be further implemented, ensuring that data collection is a by-product of care rather than an additional task. The establishment of a robust data verification process further reinforces the integrity and reliability of the data, and should be performed at least once every 2 years.

Moving forward, the authors believe a minimum annual volume should be required in all European countries. This can be achieved by implementing either a mandated minimum volume threshold or the centralization of dedicated centers based on the number of centers required to achieve the volume threshold. In 12/16 (75%) Western-European countries, a centralization strategy is currently present.⁴ Countries without or with an under-20 minimum volume threshold should initiate a threshold at a minimum of 20 esophagectomies per year, or preferably directly at 40, with strict protocols to enforce this threshold. The countries with existing volume thresholds should aim to increase this to 40–60 esophagectomies annually. Implementing a centralization strategy that encompasses the entire multidisciplinary pathway for esophageal (and gastric) cancer is also feasible, yet it requires doubling these thresholds. Additionally, these thresholds should be accompanied by clinical care standards, detailing mandatory ‘hospital resources’ for esophagectomy centers. All volumes and outcomes should be monitored and enforced through a mandatory national clinical audit, with the data also being utilized in best-practice meetings to induce further quality improvement.

Specific author contributions: Maurits R. Visser (Conceptualization, Writing—original draft), Mark van Berge Henegouwen (Conceptualization, Supervision, Writing—review & editing), and Richard van Hillegersberg (Conceptualization, Supervision, Writing—review & editing)

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