Cornelis J.H. van de Velde, MD, PhD,FRCPS(hon)FACS(hon)Professor of SurgeryPresident ECCO - the European Cancer OrganizationPast-President European Society of Surgical OncologyLeiden University Medical CenterLeiden, The Netherlands

How important is experience/volume in gastric cancer surgery?

Pean and Billroth

Surgery for gastric cancerSurgery for gastric cancer

Importance of training and team effort

• Surgical oncology is top-class sport

• Training and (multidisciplinary) team effort essential

Japanese vs Intergroup 0116 study

Japanese studyIntergroup 0116 study

red line: 60% survival, surgery only in Japanese trial

MacDonald, NEJM 2001, Sakuramoto, NEJM 2007MacDonald, NEJM 2001, Sakuramoto, NEJM 2007

Dutch Gastric Cancer Trial

Hospital volumes

• 711 gastrectomies, 80 participating hospitals

• Average of 2.2 gastrectomies/hospital/year

(registered in study)

Quality Assurance

• Instruction in operating room by Japanese surgeon

• ‘Supervising surgeons’ present with every D2 gastrectomy

• Book and video

• Teaching meetings for surgeons

Dutch Gastric Cancer Trial – 15-year follow-up

711 Patients with curative resection711 Patients with curative resection

Death of Gastric CancerD1: 48% D2: 37%P=0.01

Death of Other CausesHR=1.22P=NS

Songun, vd Velde et al, Lancet Oncology 2010

ConclusionConclusionD2 dissection should be D2 dissection should be

recommended as standard recommended as standard surgical approach in resectable surgical approach in resectable

gastric cancergastric cancer

Conclusion on surgery

• D2 dissection should be recommended

• No splenectomy or pancreatectomy

• In experienced(High volume) centers

• PAND does not improve survival any further

The effect of improvement of surgical quality over the introduction of The effect of improvement of surgical quality over the introduction of adjuvant therapyadjuvant therapy

After Dutch D1-D2 trial

During Dutch D1-D2 trial

Before Dutch D1-D2 trial

Perioperative chemotherapy

Surgery Alone

Krijnen et al., EJSO 2009Krijnen et al., EJSO 2009

Trials vs nationwide improvements

• Trials → improve outcomes by

• Providing better treatment options

• Training surgeons

• Most patients treated outside trials

• → analyze outcomes on nationwide level

2 Ways to improve surgical outcomes

Direct patients to the best places (“Centers of

Excellence”)

Improve care by everyone (“Quality improvement”)

Off-the-shelf process improvement

Outcomes-based quality improvement

Survival in the Netherlands compared to Europe

EUROCARE-4

5-Year relative survival

Europe: 24.5%

Netherlands: 18.1%

Are we doing

something wrong?

Sant et al, Eur J Cancer 2009Sant et al, Eur J Cancer 2009

Centralization in the Netherlands

Esophagectomy Gastrectomy

RED = High-volume surgery (>20/year)

• Esophagectomy: centralization effect

• Gastrectomy: decreasing number, no centralization

Dikken, vd Velde et al, EJC 2012Dikken, vd Velde et al, EJC 2012

Outcomes esophagectomy vs gastrectomy

• 6-Month mortality:

• Gastrectomy → non-significant decrease

• Esophagectomy → significant decrease

• 3-Year survival:

• Gastrectomy → no improvement

• Esophagectomy → catch-up with gastric cancer

Dikken, vd Velde et al, EJC 2012Dikken, vd Velde et al, EJC 2012

30-Day mortality in the Netherlands

Blue: esophagectomy ~ 4%

Green: gastrectomy ~ 8%

Higher mortality after gastrectomy for past 5 years

Dikken, vd Velde et al, EJC 2012Dikken, vd Velde et al, EJC 2012

Conclusion

• Urgent need for improvement of gastric cancer care in the

Netherlands

• Centralization

• Auditing

• Use of multi-modality treatment

Centralization: volume-outcome relation US

Birkmeyer et al, NEJM 2002Birkmeyer et al, NEJM 2002

“Patients can often improve their chances of survival

substantially, even at high volume hospitals, by selecting

surgeons who perform the operations frequently”

Centralization: volume-outcome relation US

Finks et al, NEJM 2012Finks et al, NEJM 2012

• 10 years after initial US paper

• Decrease in postoperative mortality

• Esophagectomy: completely due to centralization

Centralization in Denmark

Jensen et al, ejso2010Jensen et al, ejso2010

Study period 1999-2003 2003-2008

No. of departments 37 5

No. of operations 537 416

Anastomotic leakages (%) 6.1 5.0

Hospital mortality (%) 8.2 2.4

2003- Gastric cancer surgery restricted to 5 hospitals- Introduction national clinical guidelines- Introduction nationwide database

Centralization in Denmark

Jensen et al, EJSO 2010Jensen et al, EJSO 2010

Cases with at leastCases with at least15 lymph nodes 15 lymph nodes removedremoved

2003: 19%2003: 19%

2008: 67%2008: 67%

Literature on GastrectomiesNumber of patients in volume-outcome studies

• Smaller studies: often no volume-outcome effect

• Larger studies: volume-outcome effect

Literature on Gastrectomies Definition of ‘high volume’ in positive studies

• Definition of ‘high volume’ in most studies ~20/year

• But studies with higher volumes

Centralization: type of referral

Should centralization only be based on case

volume?

Volume-based vs. Outcome-based referral

Gruen et al, CA Cancer J Clin 2009Gruen et al, CA Cancer J Clin 2009

Outcome-based centralization in West-Netherlands

Surgical audit for Esophagectomies

-11 low volume hospitals

-10 years of retrospective data (1990-1999)

-INTERVENTION in 2000

-Concentration of procedures in 3 hospitals with the best performance

Wouters et al, J Surg Oncol 2009Wouters et al, J Surg Oncol 2009

Improvement after outcome-based centralization

1990-1994 1995-1999 2000-2005 N (%) N (%) N (%) P value

Margins R0 R1 R2 unknown

107 (69.5) 34 (22.1) 10 (6.5) 3 (1.9)

140 (74.9)

21 (11.2) 25 (13.4) 1 (0.5)

201 (75.8) 44 (16.6) 13 (4.9) 7 (2.6)

0.003

Surg. Complications no yes unknown

83 (53.9) 66 (42.9) 5 (3.2)

108 (57.8) 77 (41.2) 2 (1.1)

148 (55.8) 111 (41.9) 6 (2.3)

0.70

Hospital stay (days)

<0.001

median 20 21 17 (p25 – p75) (9-92) (9-125) (8-273) In hospital mortality

22 (14.3)

23 (12.3)

11 (4.2)

<0.001

Total no. of patients

154

187

265

J Surg Oncol 2009J Surg Oncol 2009

Effects on survival

Significant improvement in survival after esophagectomy

J Surg Oncol 2009J Surg Oncol 2009

Comparison with rest of the Netherlands

0

5

10

15

20

1990-1994 1995-1999 2000-2004

nation-wideIKW-region

hospital mortality

W W

W

J Surg Oncol 2009J Surg Oncol 2009

Conclusion

Outcome-based referral provides a method for

centralization

by selecting

hospitals with the best outcomes

Auditing

• Definition

• “providers of care are monitored and their performance is benchmarked against their peers”

• Surgical Hawthorne effect

• Gastric cancer audits currently performed in several European Countries

• United Kingdom

• Denmark

• Sweden

• Netherlands

Effect of auditing

Knowledge transfer

Feedback

Great Britain

National OesophagoGastric Cancer Audit

www.augis.orgwww.augis.org

- Patient characteristics

- Preoperative staging

- Treatment modalities

- Surgery

- Multi-modality

- Outcomes

- Complications/mortality

- Survival

- Quality of Life

Analyzing risk-adjusted outcomes on hospital level

www.augis.orgwww.augis.org

Netherlands

• Started as of 2011:minimal 40 procedures in 2012

• Covering all esophagectomies and gastrectomies in the

Netherlands

• Collaboration with Colorectal Audit, Breast Audit

www.clinicalaudit.nlwww.clinicalaudit.nl

International comparison

• Compare national audits and cancer registries

• Esophageal and gastric resections 2004-2009• Netherlands: N = 5,791

• Sweden: N = 653 (part of Sweden)

• Denmark: N = 1,420

• England: N = 12,000

• Goals• Compare differences between countries

• Analyse possible volume-outcome relation

Differences in 30-day mortality between countries

Esophagectomies Gastrectomies

Significant differences between countries

Differences in annual hospital volumes

• Large differences in annual hospital volumes

• Denmark: centralization of esophagectomies and gastrectomies

Esophagectomies Gastrectomies

Effect of hospital volume on 30-day mortality

Esophagectomies Gastrectomies

Lower 30-day mortality with increasing hospital volume

• Esophagectomies: up to >40/jaar

• Gastrectomies: up to >20/jaar

Conclusions

• Participating countries:

• Considerable variation in hospital volumes and 30-day

mortality

• Significant relation between volume and 30-day mortality

• But not the only explanation for differences between countries

• Limitations of this pilot study:

• Differences between used datasets

• Comorbidity, TNM stage, multimodality therapy

• Need for a uniform European Upper GI Cancer Registry

Possible purposes Data required

Compare outcomes after surgery Type of surgery, case-mix (comorbidity), complications, short-term mortality

Compare resection rates All patients with a diagnosis of oesophagogastric cancer, type of surgery

Compare patterns of care Type of surgery, chemotherapy, radiotherapy, etc.

Compare long term outcomes Follow-up data, TNM stage

European Upper GI Registry(ESSO initiative ,chair : W Allum)

Quality Assurance Project: an ESSO initiative

One European Cancer Audit

Quality Variation

Identify and spread Best Practice Research Outcome monitoring (feedback) Guidelines Development

Feedback by auditing

•Casemix adjusted

•Tools to improve

•Identify best practice

•Only feedback to participating registration

European Audit on Cancer Treatment European Audit on Cancer Treatment OutcomeOutcome

Levels of evidence

Conclusion

•Nationwide improvements require

nationwide interventions

•Centralization

•Auditing

‘The best care, for every cancer patient’