Cost-effectiveness of Laparoscopic vs Open Gastrectomy for Gastric Cancer: An Economic Evaluation Alongside a Randomized Clinical Trial.

Importance: Laparoscopic gastrectomy is rapidly being adopted worldwide as an alternative to open gastrectomy to treat gastric cancer. However, laparoscopic gastrectomy might be more expensive as a result of longer operating times and more expensive surgical materials. To date, the cost-effectiveness of both procedures has not been prospectively evaluated in a randomized clinical trial. Objective: To evaluate the cost-effectiveness of laparoscopic compared with open gastrectomy. Design, Setting, and Participants: In this multicenter randomized clinical trial of patients undergoing total or distal gastrectomy in 10 Dutch tertiary referral centers, cost-effectiveness data were collected alongside a multicenter randomized clinical trial on laparoscopic vs open gastrectomy for resectable gastric adenocarcinoma (cT1-4aN0-3bM0). A modified societal perspective and 1-year time horizon were used. Costs were calculated on the individual patient level by using hospital registry data and medical consumption and productivity loss questionnaires. The unit costs of laparoscopic and open gastrectomy were calculated bottom-up. Quality-adjusted life-years (QALYs) were calculated with the EuroQol 5-dimension questionnaire, in which a value of 0 indicates death and 1 indicates perfect health. Missing questionnaire data were imputed with multiple imputation. Bootstrapping was performed to estimate the uncertainty surrounding the cost-effectiveness. The study was conducted from March 17, 2015, to August 20, 2018. Data analyses were performed between September 1, 2020, and November 17, 2021. Interventions: Laparoscopic vs open gastrectomy. Main Outcomes and Measures: Evaluations in this cost-effectiveness analysis included total costs and QALYs. Results: Between 2015 and 2018, 227 patients were included. Mean (SD) age was 67.5 (11.7) years, and 140 were male (61.7%). Unit costs for initial surgery were calculated to be €8124 (US $8087) for laparoscopic total gastrectomy, €7353 (US $7320) for laparoscopic distal gastrectomy, €6584 (US $6554) for open total gastrectomy, and €5893 (US $5866) for open distal gastrectomy. Mean total costs after 1-year follow-up were €26 084 (US $25 965) in the laparoscopic group and €25 332 (US $25 216) in the open group (difference, €752 [US $749; 3.0%]). Mean (SD) QALY contributions during 1 year were 0.665 (0.298) in the laparoscopic group and 0.686 (0.288) in the open group (difference, -0.021). Bootstrapping showed that these differences between treatment groups were relatively small compared with the uncertainty of the analysis. Conclusions and Relevance: Although the laparoscopic gastrectomy itself was more expensive, after 1-year follow-up, results suggest that differences in both total costs and effectiveness were limited between laparoscopic and open gastrectomy. These results support centers' choosing, based on their own preference, whether to (de)implement laparoscopic gastrectomy as an alternative to open gastrectomy.

Outcomes of Combined Peritoneal and Local Treatment for Patients with Peritoneal and Limited Liver Metastases of Colorectal Origin: A Systematic Review and Meta-Analysis.

BACKGROUND: Almost half of all colorectal cancer (CRC) patients will experience metastases at some point, and in the majority of cases, multiple organs will be involved. If the peritoneum is involved in addition to the liver, the current guideline-driven treatment options are limited. The reported overall survival ranges from 6 to 13 months for the current standard of care (systemic treatment). This study aimed to evaluate morbidity and clinical long-term outcomes from a combined local treatment of hepatic metastases with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) used to treat peritoneal metastases. METHODS: A systematic search was performed in PubMed, Embase.com, Web of Science, and Cochrane. Studies evaluating the clinicopathologic data of patients who had both peritoneal and hepatic metastases treated with CRS-HIPEC were included provided sufficient data on the primary outcomes (overall and disease-free survival) were presented. The quality of included studies was assessed using the Methodological Index for Non-Randomized Studies (MINORS). RESULTS: Patients treated for peritoneal and liver metastases (PMLM group) had a pooled mean survival of 26.4 months (95% confidence interval [CI] 22.4-30.4 months), with a 3-year survival rate of 34% (95% CI 26.7-42.0%) and a 5-year survival rate of 25% (95% CI 17.3-33.8%). Surgical complications occurred more frequently for these patients than for those with peritoneal metastasis only (40% vs 22%; p = 0.0014), but the mortality and reoperation rates did not differ significantly. CONCLUSION: This systematic review showed that CRS and HIPEC combined with local treatment of limited liver metastasis for selected patients is feasible, although with increased morbidity and an association with a long-term survival rate of 25%, which is unlikely to be achievable with systemic treatment only.

Laparoscopic Versus Open Gastrectomy for Gastric Cancer (LOGICA): A Multicenter Randomized Clinical Trial.

BACKGROUND: The oncological efficacy and safety of laparoscopic gastrectomy are under debate for the Western population with predominantly advanced gastric cancer undergoing multimodality treatment. METHODS: In 10 experienced upper GI centers in the Netherlands, patients with resectable (cT1-4aN0-3bM0) gastric adenocarcinoma were randomly assigned to either laparoscopic or open gastrectomy. No masking was performed. The primary outcome was hospital stay. Analyses were performed by intention to treat. It was hypothesized that laparoscopic gastrectomy leads to shorter hospital stay, less postoperative complications, and equal oncological outcomes. RESULTS: Between 2015 and 2018, a total of 227 patients were randomly assigned to laparoscopic (n = 115) or open gastrectomy (n = 112). Preoperative chemotherapy was administered to 77 patients (67%) in the laparoscopic group and 87 patients (78%) in the open group. Median hospital stay was 7 days (interquartile range, 5-9) in both groups (P = .34). Median blood loss was less in the laparoscopic group (150 v 300 mL, P < .001), whereas mean operating time was longer (216 v 182 minutes, P < .001). Both groups did not differ regarding postoperative complications (44% v 42%, P = .91), in-hospital mortality (4% v 7%, P = .40), 30-day readmission rate (9.6% v 9.1%, P = 1.00), R0 resection rate (95% v 95%, P = 1.00), median lymph node yield (29 v 29 nodes, P = .49), 1-year overall survival (76% v 78%, P = .74), and global health-related quality of life up to 1 year postoperatively (mean differences between + 1.5 and + 3.6 on a 1-100 scale; 95% CIs include zero). CONCLUSION: Laparoscopic gastrectomy did not lead to a shorter hospital stay in this Western multicenter randomized trial of patients with predominantly advanced gastric cancer. Postoperative complications and oncological efficacy did not differ between laparoscopic gastrectomy and open gastrectomy.

Worldwide Practice in Gastric Cancer Surgery: A 6-Year Update.

OBJECTIVES: The aim of the study was to evaluate the current status of gastric cancer surgery worldwide and update the changes compared to a previous survey in 2014. METHODS: A cross-sectional survey was sent to surgical members of the International Gastric Cancer Association, pilot centers of the World Organization for Specialized Studies on Diseases of the Esophagus, and the Australian and New Zealand Gastric and Oesophageal Surgeons Association in addition to participants of the 2019 International Gastric Cancer and European Society for Diseases of the Esophagus congresses. Topics addressed included hospital volume, staging, perioperative treatment, surgical approach, anastomotic techniques, lymphadenectomy, and palliative management. RESULTS: Between June 2019 and January 2020, 165 respondents from 44 countries completed the survey. In total, 80% worked in a hospital performing >20 gastrectomies annually. Staging laparoscopy and 18F-fluorodeoxyglucose positron emission tomography with computed tomography were preferred by 68 and 26% for advanced cancer, and 90% offered perioperative chemo(radio)therapy to patients. For early cancer, a minimally invasive surgical approach was preferred by 65% for distal and by 50% for total gastrectomy. For advanced cancer, this was preferred by 39% for distal and by 33% for total gastrectomy. And 84% favored a stapled anastomosis, and 14% created a jejunal pouch as reconstruction during total gastrectomy. A D2 lymphadenectomy was preferred for distal as well as for total gastrectomy, in both early (62 and 71%) and advanced (84 and 89%) cancer. CONCLUSION: This international survey demonstrates that perioperative chemotherapy and a D2 lymphadenectomy have now become the preferred treatment for gastric cancer. A minimally invasive surgical approach has gained popularity.

Management and outcome of cervical versus intrathoracic manifestation of cervical anastomotic leakage after transthoracic esophagectomy for cancer.

The aim of this study was to evaluate management strategies and related outcomes for cervical versus intrathoracic manifestation of cervical anastomotic leakage after transthoracic esophagectomy for cancer with gastric conduit reconstruction. Patients with esophageal cancer undergoing transthoracic esophagectomy with cervical anastomosis from October 2003 to December 2014 were identified from a prospectively acquired database. Management strategies and related outcomes among patients with anastomotic leakage confined to the neck were compared to patients with intrathoracic manifestation of anastomotic leakage. From a total of 286 patients, leakage of the cervical anastomosis occurred in 60 patients (21%) at a median time of 7 days after esophagectomy. Leakage was confined to the neck in 23 of 60 patients (38%), whereas 37 of 60 patients (62%) presented with intrathoracic spread. Leakages with intrathoracic manifestation were more frequently accompanied by a positive SIRS score compared to leakages confined to the neck (73% vs. 35%, respectively; P = 0.004). Drainage of the anastomotic leakage through the neck wound was effective in all of 23 patients (100%) with cervical manifestation. In patients with intrathoracic manifestation, mediastinal drainage through the neck was successful in 15 of 37 patients (41%), whereas 22 patients (59%) required an intervention through the thoracic cavity. Compared to patients with leakage confined to the neck, patients with intrathoracic manifestation showed prolonged intensive care unit (ICU) stay (median 6 vs. 2 days, respectively; P = 0.001), hospital stay (median 34 vs. 19 days, respectively; P < 0.001), and time to oral intake (32 vs. 23 days, respectively; P = 0.018). Intrathoracic manifestation of cervical anastomotic leakage occurs in more than half of patients with anastomotic leakage after transthoracic esophagectomy for cancer. A SIRS reaction should raise the suspicion of intrathoracic spread of leakage. Intrathoracic manifestation can be managed effectively by mediastinal drainage through the neck in 41% of patients, but a reintervention through the thoracic cavity is required in 59%. Intrathoracic manifestation of leakage results in prolonged ICU/hospital stay and delays time to oral intake compared with leakage confined to the neck.

Worldwide practice in gastric cancer surgery.

AIM: To evaluate the current status of gastric cancer surgery worldwide. METHODS: An international cross-sectional survey on gastric cancer surgery was performed amongst international upper gastro-intestinal surgeons. All surgical members of the International Gastric Cancer Association were invited by e-mail to participate. An English web-based survey had to be filled in with regard to their surgical preferences. Questions asked included hospital volume, the use of neoadjuvant treatment, preferred surgical approach, extent of the lymphadenectomy and preferred anastomotic technique. The invitations were sent in September 2013 and the survey was closed in January 2014. RESULTS: The corresponding specific response rate was 227/615 (37%). The majority of respondents: originated from Asia (54%), performed > 21 gastrectomies per year (79%) and used neoadjuvant chemotherapy (73%). An open surgical procedure was performed by the majority of surgeons for distal gastrectomy for advanced cancer (91%) and total gastrectomy for both early and advanced cancer (52% and 94%). A minimally invasive procedure was preferred for distal gastrectomy for early cancer (65%). In Asia surgeons preferred a minimally invasive procedure for total gastrectomy for early cancer also (63%). A D1+ lymphadenectomy was preferred in early gastric cancer (52% for distal, 54% for total gastrectomy) and a D2 lymphadenectomy was preferred in advanced gastric cancer (93% for distal, 92% for total gastrectomy) CONCLUSION: Surgical preferences for gastric cancer surgery vary between surgeons worldwide. Although the majority of surgeons use neoadjuvant chemotherapy, minimally invasive techniques are still not widely adapted.

The Oncological Value of Omentectomy in Gastrectomy for Cancer.

AIM: The aim of this study was to determine the oncologic value of omentectomy in patients undergoing gastrectomy for gastric cancer. METHODS: All consecutive patients with gastric cancer that underwent gastrectomy with curative intent between April 2012 and August 2015 were prospectively analyzed. The greater omentum was separately marked during operation and pathologically evaluated for the presence of omental lymph nodes and tumor deposits. RESULTS: In total, 50 patients were included. The greater omentum harbored lymph nodes in nine (18 %) patients. The omental lymph nodes contained metastases in one (2 %) patient, still free of disease after 20 months. Omental tumor deposits were found in four (8 %) patients; one died <30 days postoperative and three developed peritoneal carcinomatosa after 4, 4, and 8 months. Patients with omental tumor deposits had a significantly reduced 1-year disease-free survival compared to patients without tumor deposits (0 vs. 58.7 %, p = 0.003). No predictive factors for omental tumor involvement could be identified. CONCLUSION: Omental lymph node metastases or tumor deposits are present in 10 % of Western European patients undergoing gastrectomy for gastric cancer. Omentectomy has a prognostic and oncologic value in the curative treatment of patients with gastric cancer. As no predictive factors for omental tumor involvement could be identified, omentectomy should be the standard in gastrectomy for gastric cancer patients.

Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial).

BACKGROUND: For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy. METHODS: The study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness. DISCUSSION: In this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5 years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient. TRIAL REGISTRATION: NCT02248519.

Technical Feasibility of TachoSil Application on Esophageal Anastomoses.

Purpose. Sealing esophageal anastomoses with a sealant patch (TachoSil) containing human fibrinogen and thrombin may improve mechanical strength. The aim was to evaluate the technical feasibility of the application of a sealant patch in upper gastrointestinal surgery. Methods. In total 15 patients, 18-80 years old, undergoing thoracolaparoscopic esophagectomy with esophagogastrostomy or laparoscopic total gastrectomy with esophagojejunostomy was included. Different techniques of anastomotic TachoSil patch application were tested and recorded on video. Results. TachoSil was successfully applied to the esophagogastrostomy (n = 11) and to the esophagojejunostomy (n = 4). A median of 2 (1-6) attempts was necessary to reach successful application. The median duration was 7 (3-26) minutes before successful application was accomplished. The best technique in esophagectomy was the application of TachoSil with the use of 2 cellophane sheets. For total gastrectomy, the patch was folded into a harmonica shape and wrapped around the esophagojejunostomy. Although not significant, the number of attempts and time to success showed a decreasing trend along with the increased experience. Conclusion. Application of TachoSil as a sealant of esophageal anastomoses was technically feasible. Future studies may investigate the value of TachoSil application on the prevention of anastomotic leakage.

Calcification of arteries supplying the gastric tube: a new risk factor for anastomotic leakage after esophageal surgery.

PURPOSE: To evaluate the association between the amount and location of calcifications of the supplying arteries of the gastric tube, as determined with a vascular calcification scoring system, and the occurrence of anastomotic leakage after esophagectomy with gastric tube reconstruction in patients with esophageal cancer. MATERIALS AND METHODS: Institutional review board approval was obtained, and the informed consent requirement was waived for this retrospective study. Consecutive patients who underwent elective esophagectomy for cancer with gastric tube reconstruction and cervical anastomosis between 2003 and 2012 were identified from a prospective database. Vascular calcification scores were retrospectively assigned by reviewing the routine preoperative computed tomographic (CT) images. In patients with anastomotic leakage, presence and severity of calcifications of the aorta (score of 0-2), celiac axis (score of 0-2), right postceliac arteries (common hepatic, gastroduodenal, and right gastroepiploic arteries; score of 0-1), and left postceliac arteries (splenic and left gastroepiploic arteries, score of 0-1) along with patient- and procedure-related characteristics were compared with those of patients without leakage by using multivariate logistic regression analysis. RESULTS: Of 246 patients, 58 (24%) experienced anastomotic leakage. No significant differences in patient-related factors were found between patients with leakage and those without leakage, with the exception of more chronic use of steroids in the leakage group (7% [four of 58] vs 0% [0 of 188], P = .003). At univariate analysis, leakage was more common in patients with calcification of the aorta (27% [28 of 102] and 35% [13 of 37] vs 16% [17 of 107], P = .029) and the right postceliac arteries (55% [six of 11] vs 22% [52 of 235], P = .013). At multivariate analysis, both minor (odds ratio, 2.00; 95% confidence interval: 1.02, 3.94) and major (odds ratio, 2.87; 95% confidence interval: 1.22, 6.72) aortic calcifications were associated with leakage. Also, an independent association with leakage was found for calcifications of the right postceliac arteries (odds ratio, 4.22; 95% confidence interval: 1.24, 14.4). CONCLUSION: Atherosclerotic calcification of the aorta and right postceliac arteries that supply the gastric tube is an independent risk factor for anastomotic leakage after esophagectomy.

Surgical treatments for esophageal cancers.

The following, from the 12th OESO World Conference: Cancers of the Esophagus, includes commentaries on the role of the nurse in preparation of esophageal resection (ER); the management of patients who develop high-grade dysplasia after having undergone Nissen fundoplication; the trajectory of care for the patient with esophageal cancer; the influence of the site of tumor in the choice of treatment; the best location for esophagogastrostomy; management of chylous leak after esophagectomy; the optimal approach to manage thoracic esophageal leak after esophagectomy; the choice for operational approach in surgery of cardioesophageal crossing; the advantages of robot esophagectomy; the place of open esophagectomy; the advantages of esophagectomy compared to definitive chemoradiotherapy; the pathologist report in the resected specimen; the best way to manage patients with unsuspected positive microscopic margin after ER; enhanced recovery after surgery for ER: expedited care protocols; and long-term quality of life in patients following esophagectomy.

Surgical techniques to prevent delayed gastric emptying after esophagectomy with gastric interposition: a systematic review.

Delayed gastric emptying is observed in 10% to 50% of patients after esophagectomy with gastric interposition. The effects of gastric interposition diameter, pyloric drainage, reconstructive route, and anastomotic site on postoperative gastric emptying were systematically reviewed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Most studies showed superior passage of the gastric tube compared with the whole stomach. Pyloric drainage is not significantly associated with the risk of developing delayed gastric emptying after esophagectomy. For reconstructive route and anastomotic site, available evidence on delayed gastric emptying is limited. Prospectively randomized studies with standardized outcome measurements are recommended.

[Surgical treatment of gastric cancer: focus on centralisation and laparoscopic resections]. / Chirurgische behandeling van maagcarcinoom: focus op centralisatie en laparoscopische resecties.

Approximately 2000 patients are diagnosed with gastric carcinoma in the Netherlands each year; about 500 will be eligible for curative surgical treatment. The 5-year survival rate after therapy aimed at curing the condition is 45%, which can increase by an average of 10% if perioperative chemotherapy is added to the treatment regimen. Surgical treatment consists of a distal or total gastrectomy with spleen-preserving lymphadenectomy. Centralising this type of treatment leads to less postoperative mortality and better oncological outcomes. There are indications that laparoscopic surgery can accelerate postoperative recovery time. There are insufficient long-term data on outcomes of laparoscopic surgery to date to be able to conclude whether the laparoscopic or open approach to total gastric resection is preferable.

End-to-end cervical esophagogastric anastomoses are associated with a higher number of strictures compared with end-to-side anastomoses.

BACKGROUND: Leakage and benign strictures occur frequently after esophagectomy. The objective of this study was to analyze the outcome of hand-sewn end-to-end versus end-to-side cervical esophagogastric anastomoses. METHODS: A series of 390 consecutive patients who underwent esophagectomy with gastric conduit reconstruction was analyzed. RESULTS: The end-to-end technique was performed in 112 (29 %) patients and the end-to-side in 278 (71 %) patients. Anastomotic leakage occurred in 20 (18 %) patients with an end-to-end anastomosis versus 58 (21 %) patients with an end-to-side anastomosis (p = 0.50). A higher incidence in anastomotic strictures was seen in end-to-end anastomoses (48 (43 %)) compared with end-to-side anastomoses (89 (32 %); p = 0.04). Moreover, a median of 11 (7-17) dilations was necessary in patients with a benign anastomotic stricture in the end-to-end group compared with four (2-8) dilations in patients with a benign anastomotic stricture in the end-to-end group (p < 0.036). After multivariate analysis, the difference in anastomotic leakage rates remained nonsignificant (p = 0.74), whereas anastomotic stricture rate and number of dilations were higher in the end-to-end group (p = 0.03 and p = 0.01, respectively). CONCLUSION: The technique of anastomosis is not significantly related to anastomotic leakage rate. However, patients with end-to-end anastomoses develop postoperative strictures more frequently, requiring a higher number of dilations compared to end-to-side anastomoses.

Laparoscopic total gastrectomy versus open total gastrectomy for cancer: a systematic review and meta-analysis.

BACKGROUND: The possible advantages of laparoscopic (assisted) total gastrectomy (LTG) versus open total gastrectomy (OTG) have not been reviewed systematically. The aim of this study was to systematically review the short-term outcomes of LTG versus OTG in the treatment of gastric cancer. METHODS: A systematic search of PubMed, Cochrane, CINAHL, and Embase was conducted. All original studies comparing LTG with OTG were included for critical appraisal. Data describing short-term outcomes were pooled and analyzed. RESULTS: A total of eight original studies that compared LTG (n = 314) with OTG (n = 384) in patients with gastric cancer fulfilled quality criteria and were selected for review and meta-analysis. LTG compared with OTG was associated with a significant reduction of intraoperative blood loss (weighted mean difference = 227.6 ml; 95 % CI 144.3-310.9; p < 0.001), a reduced risk of postoperative complications (risk ratio = 0.51; 95 % CI 0.33-0.77), and shorter hospital stay (weighted mean difference 4.0 = days; 95 % CI 1.4-6.5; p < 0.001). These benefits were at the cost of longer operative time (weighted mean difference = 55.5 min; 95 % CI 24.8-86.2; p < 0.001). In-hospital mortality rates were comparable for LTG (0.9 %) and OTG (1.8 %) (risk ratio = 0.68; 95 % CI 0.20-2.36). CONCLUSION: LTG shows better short term outcomes compared with OTG in eligible patients with gastric cancer. Future studies should evaluate 30- and 60-day mortality, radicality of resection, and long-term follow-up in LTG versus OTG, preferably in randomized trials.

Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial).

BACKGROUND: For esophageal cancer patients, radical esophagolymphadenectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for en-bloc resection of the tumor with the surrounding lymph nodes. However, the percentage of cardiopulmonary complications associated with the transthoracic approach is high (50 to 70%).Recent studies have shown that robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RATE) is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes. RATE was accompanied with reduced blood loss, shorter ICU stay and improved lymph node retrieval compared with open esophagectomy, and the pulmonary complication rate, hospital stay and perioperative mortality were comparable. The objective is to evaluate the efficacy, risks, quality of life and cost-effectiveness of RATE as an alternative to open transthoracic esophagectomy for treatment of esophageal cancer. METHODS/DESIGN: This is an investigator-initiated and investigator-driven monocenter randomized controlled parallel-group, superiority trial. All adult patients (age ≥ 18 and ≤ 80 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) esophageal carcinoma of the intrathoracic esophagus and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n = 112) with resectable esophageal cancer are randomized in the outpatient department to either RATE (n = 56) or open three-stage transthoracic esophageal resection (n = 56). The primary outcome of this study is the percentage of overall complications (grade 2 and higher) as stated by the modified Clavien-Dindo classification of surgical complications. DISCUSSION: This is the first randomized controlled trial designed to compare RATE with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer. If our hypothesis is proven correct, RATE will result in a lower percentage of postoperative complications, lower blood loss, and shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with open transthoracic esophagectomy. The study started in January 2012. Follow-up will be 5 years. Short-term results will be analyzed and published after discharge of the last randomized patient. TRIAL REGISTRATION: Dutch trial register: NTR3291 ClinicalTrial.gov: NCT01544790.

[Acute renal failure due to Cortinarius poisoning]. / Acuut nierfalen door vergiftiging met gordijnzwam.

BACKGROUND: Ingestion of certain Cortinarius species may lead to renal failure. In the Netherlands, this type of poisoning has not been previously described. CASUS: A 58-year-old female presented with headache, vomiting and oliguria, preceded by a few days of burning, painful thirst and malaise. She had acute and irreversible renal failure of unknown cause. History revealed that two days before the onset of her symptoms, she had eaten a ragout prepared with mushrooms that were picked in a forest. A renal biopsy demonstrated interstitial nephritis with proximal tubular necrosis. In the leftovers of the ragout two fragments of Cortinarius mushroom, probably belonging to the complex of Cortinarius cinnamomeus (cinnamon webcap), were found. First signs and symptoms, and the course are compatible with those described in the literature on Cortinarius poisoning. Despite haemodialysis and administration of acetylcysteine and glucocorticoids, her renal function did not recover. CONCLUSION: This case is the first description of mushroom poisoning by a species of the genus Cortinarius in the Netherlands.