Learning Curve of Laparoscopic Gastrectomy: A Multicenter Study.

OBJECTIVE: To evaluate the learning curve of laparoscopic gastrectomy (LG) after an implementation program. BACKGROUND: Although LG is increasingly being performed worldwide, little is known about the learning curve. METHODS: Consecutive patients who underwent elective LG for gastric adenocarcinoma with curative intent in each of the 5 highest-volume centers in the Netherlands were enrolled. Generalized additive models and a 2-piece model with a break point were used to determine the learning curve length. Analyses were corrected for casemix and were performed for LG and for the subgroups distal gastrectomy (LDG) and total gastrectomy (LTG). The learning curve effect was assessed for (1) anastomotic leakage; and (2) the occurrence of postoperative complications, conversions to open surgery, and short-term oncological parameters. RESULTS: In total 540 patients were included for analysis, 108 patients from each center; 268 patients underwent LDG and 272 underwent LTG. First, for LG, no learning effect regarding anastomotic leakage could be identified: the rate of anastomotic leakage initially increased, then reached a plateau after 36 cases at 10% anastomotic leakage. Second, the level of overall complications reached a plateau after 20 cases, at 38% overall complications, and at 5% conversions. For both LDG and LTG, each considered separately, fluctuations in secondary outcomes and anastomotic leakage followed fluctuations in casemix. CONCLUSION: On the basis of our study of the first 108 procedures of LG in 5 high-volume centers with well-trained surgeons, no learning curve effect could be identified regarding anastomotic leakage. A learning curve effect was found with respect to overall complications and conversion rate.

Outcomes of Esophagogastric Cancer Surgery During Eight Years of Surgical Auditing by the Dutch Upper Gastrointestinal Cancer Audit (DUCA).

OBJECTIVE: To evaluate changes in treatment and outcomes of esophagogastric cancer surgery after introduction of the DUCA. In addition, the presence of risk-averse behavior was assessed. SUMMARY OF BACKGROUND DATA: Clinical auditing is seen as an important quality improvement tool; however, its long-term efficacy remains largely unknown. In addition, critics claim that enhancements result from risk-averse behavior rather than positive effects of auditing. METHODS: DUCA data were used from registration start (1-1-2011) until 31-12-2018. Trends in patient, tumor, hospital and treatment characteristics were univariably assessed. Trends in short-term outcomes were investigated using multilevel multivariable logistic regression. Presence of risk aversion was described by the corrected proportion of patients undergoing surgery, using data from the Netherlands Cancer Registry. To evaluate the impact of centralization on time trends identified, the association between hospital volume and outcomes was investigated. RESULTS: This study included 6172 patients with esophageal and 3,690 with gastric cancer who underwent surgery. Pathological outcomes (lymph node yield, radicality) improved and futile surgery decreased over the years. In-hospital/30-day mortality decreased for esophagectomy (4.2% to 2.5%) and for gastrectomy (7.1% to 4.3%). Reinterventions, (minor) complications and readmissions increased. Risk aversion appeared absent. Between 2011-2018, annual median hospital volumes increased from 38 to 53 for esophagectomy and from 14 to 29 for gastrectomy. Higher hospital volumes were associated with several improved outcomes measures. CONCLUSIONS: During 8 years of auditing, outcomes improved, with no signs of risk-averse behavior. These improvements occurred in parallel with centralization. Feedback on postoperative complications remains the focus of the DUCA.

Impact of pathological tumor response after CROSS neoadjuvant chemoradiotherapy followed by surgery on long-term outcome of esophageal cancer: a population-based study.

BACKGROUND: With increasing interest in organ-preserving strategies for potentially curable esophageal cancer, real-world data is needed to understand the impact of pathological tumor response after neoadjuvant chemoradiotherapy (CRT) on patient outcome. The objective of this study is to assess the association between pathological tumor response following CROSS neoadjuvant CRT and long-term overall survival (OS) in a nationwide cohort. MATERIAL AND METHODS: All patients diagnosed in the Netherlands with potentially curable esophageal cancer between 2009 and 2017, and treated with neoadjuvant CRT followed by esophagectomy were included. Through record linkage with the nationwide Dutch Pathology Registry (PALGA), pathological data were obtained. The primary outcome was pathological tumor response based on ypTNM, classified into pathological complete response (ypT0N0) and incomplete responders (ypT0N+, ypT+N0, and ypT+N+). Multivariable logistic and Cox regression models were used to identify predictors of pathological complete response (pCR) and survival. RESULTS: A total of 4946 patients were included. Overall, 24% achieved pCR, with 19% in adenocarcinoma and 42% in squamous cell carcinoma. Patients with pCR had a better estimated 5-year OS compared to incomplete responders (62% vs. 38%, p< .001). Of the patients with incomplete response, ypT+N+ patients (32% of total population) had the lowest estimated 5-year OS rate, followed by ypT0N+ and ypT+ N0 (22%, 47%, and 49%, respectively, p< .001). Adenocarcinoma, well to moderate differentiation, cT3-4, cN+, signet ring cell differentiation and lymph node yield (≥15) were associated with lower likelihood of pCR. CONCLUSION: In this population-based study, pathological tumor response based on the ypTNM-stage was associated with different prognostic subgroups. A quarter of patients achieved ypT0N0 with favorable long-term survival, while one-third had an ypT+N+ response with very poor survival. The association between pathological tumor response and long-term survival could help in more accurate assessments of individual prognosis and treatment decisions.

Postoperative intensive care unit stay after minimally invasive esophagectomy shows large hospital variation. Results from the Dutch Upper Gastrointestinal Cancer Audit.

INTRODUCTION: The value of routine intensive care unit (ICU) admission after minimally invasive esophagectomy (MIE) has been questioned. This study aimed to investigate Dutch hospital variation regarding length of direct postoperative ICU stay, and the impact of this hospital variation on short-term surgical outcomes. MATERIALS AND METHODS: Patients registered in the Dutch Upper Gastrointestinal Cancer Audit (DUCA) undergoing curative MIE were included. Length of direct postoperative ICU stay was dichotomized around the national median into short ICU stay ( ≤ 1 day) and long ICU stay ( > 1 day). A case-mix corrected funnel plot based on multivariable logistic regression analyses investigated hospital variation. The impact of this hospital variation on short-term surgical outcomes was investigated using multilevel multivariable logistic regression analyses. RESULTS: Between 2017 and 2019, 2110 patients from 16 hospitals were included. Median length of postoperative ICU stay was 1 day [hospital variation: 0-4]. The percentage of short ICU stay ranged from 0 to 91% among hospitals. Corrected for case-mix, 7 hospitals had statistically significantly higher short ICU stay rates and 6 hospitals had lower rates. ICU readmission, in-hospital/30-day mortality, failure to rescue, postoperative pneumonia, cardiac complications and anastomotic leakage were not associated with hospital variation in length of ICU stay. Total length of hospital stay was significantly shorter in hospitals with relatively short ICU stay. CONCLUSION: This study showed significant hospital variation in postoperative length of ICU stay after MIE. Short ICU stay was associated with shorter overall hospital admission and did not negatively impact short-term surgical outcomes. More selected use of ICU resources could result in a national significant cost reduction.

Failure to Cure in Patients Undergoing Surgery for Gastric Cancer: A Nationwide Cohort Study.

BACKGROUND: This study aimed to describe the incidence of failure to cure (a composite outcome measure defined as surgery not meeting its initial aim), and the impact of hospital variation in the administration of neoadjuvant therapy on this outcome measure. METHODS: All patients in the Dutch Upper Gastrointestinal Cancer Audit undergoing curatively intended gastric cancer surgery in 2011-2019 were included. Failure to cure was defined as (1) 'open-close' surgery; (2) irradical surgery (R1/R2); or (3) 30-day/in-hospital mortality. Case-mix-corrected funnel plots, based on multivariable logistic regression analyses, investigated hospital variation. The impact of a hospital's tendency to administer neoadjuvant chemotherapy on the heterogeneity in failure to cure between hospitals was assessed based on median odds ratios and multilevel logistic regression analyses. RESULTS: Some 3862 patients from 28 hospitals were included. Failure to cure was noted in 22.3% (hospital variation: 14.5-34.8%). After case-mix correction, two hospitals had significantly higher-than-expected failure to cure rates, and one hospital had a lower-than-expected rate. The failure to cure rate was significantly higher in hospitals with a low tendency to administer neoadjuvant chemotherapy. Approximately 29% of hospital variation in failure to cure could be attributed to different hospital policies regarding neoadjuvant therapy. CONCLUSIONS: Failure to cure has an incidence of 22% in patients undergoing gastric cancer surgery. Higher failure to cure rates were seen in centers administering less neoadjuvant chemotherapy, which confirms the Dutch guideline recommendation on the administration of neoadjuvant chemotherapy. Failure to cure provides short loop feedback and can be used as a quality indicator in surgical audits.

Length of hospital stay after uncomplicated esophagectomy. Hospital variation shows room for nationwide improvement.

BACKGROUND: Within the scope of value-based health care, this study aimed to analyze Dutch hospital performance in terms of length of hospital stay after esophageal cancer surgery and its association with 30-day readmission rates. Since both parameters are influenced by the occurrence of complications, this study only included patients with an uneventful recovery after esophagectomy. METHODS: All patients registered in the Dutch Upper Gastrointestinal Cancer Audit (DUCA) who underwent a potentially curative esophagectomy between 2015 and 2018 were considered for inclusion. Patients were excluded in case of an intraoperative/post-operative complication, readmission to the intensive care unit, or any re-intervention. Length of hospital stay was dichotomized around the national median into 'short admissions' and 'long admissions'. Hospital variation was evaluated using a case-mix-corrected funnel plot based on multivariable logistic regression analyses. Association of length of hospital stay with 30-day readmission rates was investigated using the χ2-statistic. RESULTS: A total of 1007 patients was included. National median length of hospital stay was 9 days, ranging from 6.5 to 12.5 days among 17 hospitals. The percentage of 'short admissions' per hospital ranged from 7.7 to 93.5%. After correction for case-mix variables, 3 hospitals had significantly higher 'short admission' rates and 4 hospitals had significantly lower 'short admission' rates. Overall, 6.2% [hospital variation (0.0-13.2%)] of patients were readmitted. Hospital 30-day readmission rates were not significantly different between patients with a short length of hospital stay and those with a long length of hospital stay (5.5% versus 7.6%; p = 0.19). CONCLUSIONS: Based on these nationwide audit data, median length of hospital stay after an uncomplicated esophagectomy was 9 days ranging from 6.5 to 12.5 days among Dutch hospitals. There was no association between length of hospital stay and readmission rates. Nationwide improvement might lead to a substantial reduction of hospital costs.

A Propensity Score-Matched Cohort Study to Evaluate the Association of Lymph Node Retrieval with Long-Term Overall Survival in Patients with Esophageal Cancer.

BACKGROUND: Previous studies evaluating the association of lymph node (LN) yield and survival presented conflicting results and many may be influenced by confounding and stage migration. OBJECTIVE: This study aimed to evaluate whether the quality indicator 'retrieval of at least 15 LNs' is associated with better long-term survival and more accurate pathological staging in patients with esophageal cancer treated with neoadjuvant chemoradiotherapy and resection. METHODS: Data of esophageal cancer patients who underwent neoadjuvant chemoradiotherapy and surgery between 2011 and 2016 were retrieved from the Dutch Upper Gastrointestinal Cancer Audit. Patients with < 15 and ≥ 15 LNs were compared after propensity score matching based on patient and tumor characteristics. The primary endpoint was 3-year survival. To evaluate the effect of LN yield on the accuracy of pathological staging, pathological N stage was evaluated and 3-year survival was analyzed in a subgroup of patients with node-negative disease. RESULTS: In 2260 of 3281 patients (67%) ≥ 15 LNs were retrieved. In total, 992 patients with ≥ 15 LNs were matched to 992 patients with < 15 LNs. The 3-year survival did not differ between the two groups (57% vs. 54%; p = 0.28). pN+ was scored in 41% of patients with ≥ 15 LNs versus 35% of patients with < 15 LNs. For node-negative patients, the 3-year survival was significantly better for patients with ≥ 15 LNs (69% vs. 61%, p = 0.01). CONCLUSIONS: n this propensity score-matched cohort, 3-year survival was comparable for patients with ≥ 15 LNs, although increasing nodal yield was associated with more accurate staging. In node-negative patients, 3-year survival was higher for patients with ≥ 15 LNs.

Failure to Cure in Patients Undergoing Surgery for Esophageal Carcinoma: Hospital of Surgery Influences Prospects for Cure: A Nation-wide Cohort Study.

OBJECTIVE: This study aimed to describe failure to cure in terms of incidence, hospital variation, and as an outcome parameter for salvage esophagectomy. SUMMARY BACKGROUND DATA: Failure to cure is a composite outcome measure that could be used for hospital comparison in esophageal carcinoma care. METHODS: All patients registered in the Dutch Upper GI Cancer Audit who underwent potentially curative esophageal carcinoma surgery in 2011 to 2018, were included in this nationwide cohort study. Failure to cure was defined as: 1) no surgical resection due to intraoperative metastasis or locally irresectable tumor, 2) macroscopically or microscopically incomplete resection, or 3) 30-day/in-hospital mortality. Association of baseline characteristics with failure to cure was analyzed using multivariable logistic regression in the total population and in salvage patients. RESULTS: Some 5894 patients from 22 hospitals were included, of whom 630 (10.7%) had failure to cure (hospital variation [5.5%-19.1%]). Higher age, preoperative weight loss, higher ASA-score, higher N-stage, neoadjuvant chemotherapy, or no neoadjuvant therapy (compared with neoadjuvant chemoradiotherapy), open surgery, and resection before 2014 were associated with failure to cure. After case-mix correction, 2 hospitals had statistically significant higher failure to cure percentages, whereas 2 had lower percentages. Of 151 salvage esophagectomy patients, 32.5% had failure to cure. The failure to cure rate after salvage surgery was 27.6% in high-volume hospitals and 47.6% in medium-volume hospitals. CONCLUSIONS: The incidence of failure to cure was 10.7%. Given the significant hospital variation in the percentage of failure to cure, improvement is needed. Since salvage procedures are more often successful in high-volume hospitals, further centralization of this procedure is warranted.

Population-based study on practice variation regarding preoperative systemic chemotherapy in patients with colorectal liver metastases and impact on short-term outcomes.

INTRODUCTION: Definitions regarding resectability and hence indications for preoperative chemotherapy vary. Use of preoperative chemotherapy may influence postoperative outcomes. This study aimed to assess the variation in use of preoperative chemotherapy for CRLM and related postoperative outcomes in the Netherlands. MATERIALS AND METHODS: All patients who underwent liver resection for CRLM in the Netherlands between 2014 and 2018 were included from a national database. Case-mix factors contributing to the use of preoperative chemotherapy, hospital variation and postoperative outcomes were assessed using multivariable logistic regression. Postoperative outcomes were postoperative complicated course (PCC), 30-day morbidity and 30-day mortality. RESULTS: In total, 4469 patients were included of whom 1314 patients received preoperative chemotherapy and 3155 patients did not. Patients receiving chemotherapy were significantly younger (mean age (+SD) 66.3 (10.4) versus 63.2 (10.2) p < 0.001) and had less comorbidity (Charlson scores 2+ (24% versus 29%, p = 0.010). Unadjusted hospital variation concerning administration of preoperative chemotherapy ranged between 2% and 55%. After adjusting for case-mix factors, three hospitals administered significantly more preoperative chemotherapy than expected and six administered significantly less preoperative chemotherapy than expected. PCC was 12.1%, 30-day morbidity was 8.8% and 30-day mortality was 1.5%. No association between preoperative chemotherapy and PCC (OR 1.24, 0.98-1.55, p = 0.065), 30-day morbidity (OR 1.05, 0.81-1.39, p = 0.703) or with 30-day mortality (OR 1.22, 0.75-2.09, p = 0.467) was found. CONCLUSION: Significant hospital variation in the use of preoperative chemotherapy for CRLM was present in the Netherlands. No association between postoperative outcomes and use of preoperative chemotherapy was found.

Variation in Surgical Treatment of Abdominal Aortic Aneurysms With Small Aortic Diameters in the Netherlands.

OBJECTIVE: To evaluate reasons to deviate from aneurysm diameter thresholds, and focus on the difference in how Dutch vascular surgical units (VSUs) perceive their deviation and their actual deviation. BACKGROUND: Guidelines recommend surgical treatment for asymptomatic abdominal aortic aneurysms (AAAs) with a diameter of at least 55 mm for men and 50 mm for women. We evaluate reasons to deviate from these guidelines, and focus on the difference in how Dutch vascular surgical units (VSUs) perceive their deviation and their actual deviation. METHODS: All patients undergoing elective AAA repair between 2013 and 2016 registered in the Dutch Surgical Aneurysm Audit (DSAA) were included. Surgery at diameters of <55 mm for men and <50 mm for women were considered guideline deviations. National deviation and hospital variation in deviation were evaluated over time. Questionnaires were distributed among all Dutch VSUs, inquiring for acceptable reasons for guideline deviation. VSUs were asked to estimate the guideline deviation percentage in their hospital which was then compared with their DSAA percentage. RESULTS: In all, 9039 patients were included. In 15%, we found guideline deviation, varying from 2% to 40% between VSUs. Over time, 21 VSUs were identified with a lower percentage of deviation than the national mean each year and 8 VSUs with a higher percentage. 44/60 VSUs completed the questionnaire. Most commonly reported reasons to deviate were concomitant large iliac diameter (91%) and saccular aneurysm (82%). The majority of the VSUs (77%) estimated their guideline deviation to be <5%. Eleven VSUs (25%) estimated their deviation concordant with their DSAA percentage, but 75% of VSUs underestimated their deviation. CONCLUSIONS: Dutch VSUs regularly deviate from the guidelines regarding aneurysm diameter, with variation between VSUs. Consensus exists amongst VSUs on acceptable reasons for guideline deviations; however, the majority underestimates their actual deviation percentage.

Reporting National Outcomes After Esophagectomy and Gastrectomy According to the Esophageal Complications Consensus Group (ECCG).

OBJECTIVE: This nation-wide population-based study aimed to report postoperative morbidity and mortality after esophagectomy and gastrectomy in the Netherlands according to the definitions of the Esophagectomy Complications Consensus Group (ECCG). BACKGROUND: To standardize international outcome reporting in esophageal surgery, the ECCG developed a standardized outcomes set. METHODS: For this national cohort study, all patients undergoing esophagectomy or gastrectomy for cancer between 2016 and 2017 were selected from the Dutch Upper gastrointestinal Cancer Audit. In a random sample of hospitals, data completeness and accuracy were validated by reabstraction of the data. The investigated outcomes in the present study were postoperative complications, major complications (Clavien-Dindo grade ≥III), and 30-day mortality, according to definitions of the ECCG. RESULTS: A total of 2545 patients from 22 hospitals were included. The completeness of the Dutch Upper gastrointestinal Cancer Audit was estimated at 99.8%. Data accuracy on different items was 94% to 100%. After esophagectomy, 1046 of 1617 patients (65%) had a postoperative complication including 468 patients (29%) with a major complication. Most common complications were pneumonia (21%), esophago-enteric leak from anastomosis, staple line or localized conduit necrosis (19%), and atrial dysrhythmia (15%). The 30-day mortality was 1.7%. After gastrectomy, 397 of 928 patients (42%) had a postoperative complication including 180 patients (19%) with a major complication. Most common complications were pneumonia (12%), esophago-enteric leak from anastomosis, staple line or localized conduit necrosis (9%), and acute delirium (5%). The 30-day mortality was 4.4%. CONCLUSIONS: Reporting complications according to the ECCG platform is feasible in the Netherlands and facilitates international benchmarking.

A National Cohort Study Evaluating the Association Between Short-term Outcomes and Long-term Survival After Esophageal and Gastric Cancer Surgery.

OBJECTIVE: The aim of this study was to investigate the association between short-term outcome indicators and long-term survival after esophagogastric resections. SUMMARY BACKGROUND DATA: Short-term outcome indicators are often used to compare performance between care providers. Some short-term outcome indicators concern the direct quality of care, that is, complications, others are used because they are expected to be associated with long-term outcomes. METHOD: For this national cohort study, all patients who underwent esophagectomy or gastrectomy for cancer with curative intent between 2011 and 2016 and were registered in the Dutch Upper gastrointestinal Cancer Audit were included. Primary outcome was conditional survival (under the condition of surviving the first postoperative 30 days and hospital admission). Cox regression modeling was used to study the independent association between "textbook outcome" with survival. "Textbook outcome," a composite quality indicator, was defined as a pathological complete resection with at least 15 retrieved lymph nodes, an uneventful postoperative course, and no hospital readmission. RESULTS: In total, 4414 and 2943 patients with esophageal or gastric cancer, respectively, were included. The 1-, 2-, and 3-year overall survival rates were 76%, 62%, and 54%, and 71%, 56%, and 49% for esophageal and gastric cancer, respectively. Textbook outcome was achieved in 33% and 35% of patients respectively. "Textbook outcome" was independently associated with longer conditional survival [hazard ratio: 0.75 (95% confidence interval, 0.68-0.84) and 0.69 (0.60-0.79), respectively]. CONCLUSION: This study showed that the short-term outcome indicator textbook outcome is associated with long-term overall survival and therefore may accentuate the importance of using these indicators in clinical audits.

Population-Based Study on Risk Factors for Tumor-Positive Resection Margins in Patients with Gastric Cancer.

BACKGROUND: Radical gastrectomy is the cornerstone of the treatment of locally advanced gastric cancer. This study was designed to evaluate factors associated with a tumor-positive resection margin after gastrectomy and to evaluate the influence of hospital volume. METHODS: In this Dutch cohort study, patients with junctional or gastric cancer who underwent curative gastrectomy between 2011 and 2017 were included. The primary outcome was incomplete tumor removal after the operation defined as the microscopic presence of tumor cells at the resection margin. The association of patient and disease characteristics with incomplete tumor removal was tested with multivariable regression analysis. The association of annual hospital volume with incomplete tumor removal was tested and adjusted for the patient- and disease characteristics. RESULTS: In total, 2799 patients were included. Incomplete tumor removal was seen in 265 (9.5%) patients. Factors associated with incomplete tumor removal were: tumor located in the entire stomach (odds ratio (OR) [95% confidence interval (CI): 3.38 [1.91-5.96] reference: gastroesophageal junction), cT3, cT4, cTx (1.75 [1.20-2.56], 2.63 [1.47-4.70], 1.60 [1.03-2.48], reference: cT0-2), pN+ (2.73 [1.96-3.80], reference: pN-), and diffuse and unknown histological subtype (3.15 [2.14-4.46] and 2.05 [1.34-3.13], reference: intestinal). Unknown differentiation grade was associated with complete tumor removal (0.50 [0.30-0.83], reference: poor/undifferentiated). Compared with a hospital volume of < 20 resections/year, 20-39, and > 39 resections were associated with lower probability for incomplete tumor removal (OR 0.56 [0.42-0.76] and 0.34 [0.18-0.64]). CONCLUSIONS: Tumor location, cT, pN, histological subtype, and tumor differentiation are associated with incomplete tumor removal. The association of incomplete tumor removal with an annual hospital volume of < 20 resections may underline the need for further centralization of gastric cancer care in the Netherlands.

Implementation and first results of a mandatory, nationwide audit on liver surgery.

BACKGROUND: The Dutch Hepato Biliary Audit (DHBA) was initiated in 2013 to assess the national quality of liver surgery. This study aimed to describe the initiation and implementation of this audit along with an overview of the results and future perspectives. METHODS: Registry of patients undergoing liver surgery for all primary and secondary liver tumors in the DHBA is mandatory. Weekly, benchmarked information on process and outcome measures is reported to surgical teams. In this study, the first results of patients with colorectal liver metastases were presented, including results of data verification. RESULTS: Between 2014 and 2017, 6241 procedures were registered, including 4261 (68%) resections for colorectal liver metastases. For minor- and major liver resections for colorectal liver metastases, the median [interquartile range] hospital stay was 6 [4-8] and 8 [6-12] days, respectively. A postoperative complicated course (complication leading to >14 days of hospital stay, reintervention or death) occurred in 26% and 43% and the 30-day/in-hospital mortality was 1% and 4%, respectively. The completeness of data was 97%. In 3.6% of patients, a complicated postoperative course was erroneously omitted. CONCLUSION: Nationwide implementation of the DHBA has been successful. This was the first step in creating a complete evaluation of the quality of liver surgery.