Three-year survival and distribution of lymph node metastases in gastric cancer following neoadjuvant chemotherapy: results from a European randomized clinical trial.

BACKGROUND: Adequate lymphadenectomy is an important step in gastrectomy for cancer, with a modified D2 lymphadenectomy being recommended for advanced gastric cancers. When assessing a novel technique for the treatment of gastric cancer, lymphadenectomy should be non-inferior. The aim of this study was to assess completeness of lymphadenectomy and distribution patterns between open total gastrectomy (OTG) and minimally invasive total gastrectomy (MITG) in the era of peri-operative chemotherapy. METHODS: This is a retrospective analysis of the STOMACH trial, a randomized clinical trial in thirteen hospitals in Europe. Patients were randomized between OTG and MITG for advanced gastric cancer after neoadjuvant chemotherapy. Three-year survival, number of resected lymph nodes, completeness of lymphadenectomy, and distribution patterns were examined. RESULTS: A total of 96 patients were included in this trial and randomized between OTG (49 patients) and MITG (47 patients). No difference in 3-year survival was observed, this was 57.1% in OTG group versus 46.8% in MITG group (P = 0.186). The mean number of examined lymph nodes per patient was 44.3 ± 16.7 in the OTG group and 40.7 ± 16.3 in the MITG group (P = 0.209). D2 lymphadenectomy of 71.4% in the OTG group and 74.5% in the MITG group was performed according to the surgeons; according to the pathologist compliance to D2 lymphadenectomy was 30% in the OTG group and 36% in the MITG group. Tier 2 lymph node metastases (stations 7-12) were observed in 19.6% in the OTG group versus 43.5% in the MITG group (P = 0.024). CONCLUSION: No difference in 3-year survival was observed between open and minimally invasive gastrectomy. No differences were observed for lymph node yield and type of lymphadenectomy. Adherence to D2 lymphadenectomy reported by the pathologist was markedly low.

Does preoperative weight loss in a specialist medical weight management centre influence postoperative weight loss after bariatric surgery?

Weight loss of 5%-10% is advised in medical weight management (MWM) programmes prior to bariatric surgery but it remains to be established whether it influences postoperative weight loss outcomes. We studied postoperative percent total weight loss (%TWL) in 168 patients categorized by preoperative referral weight loss <5% or ≥5% in a UK NHS bariatric centre. Eighty-six (51.2%) patients achieved sustained referral weight loss <5% (Group A) and 82 (48.8%) ≥5% (Group B). Overall postoperative %TWL in Group A compared with Group B was 30.0% versus 28.3% (p = .30) at 12 months and 32.5% versus 29.6% (p = .20) at 24 months. There were no significant differences in postoperative %TWL at 12 and 24 months when categorized by procedure (gastric bypass, n = 106; or sleeve gastrectomy, n = 62), age or sex. Preoperative weight loss during intensive specialist MWM did not influence postoperative weight loss up to 24 months with gastric bypass or sleeve gastrectomy.

Weight loss and metabolic outcomes in women with or without polycystic ovarian syndrome after Roux-en-Y gastric bypass: A case-matched study.

BACKGROUND AND OBJECTIVES: Weight loss is the mainstay of management for women with polycystic ovarian syndrome (PCOS). However, lifestyle and dietary modifications, and gastric banding have generally poor long-term efficacy. We aimed to investigate whether gastric bypass is equally efficacious in women with or without PCOS. METHODS: We performed a matched case-control study of primary Roux-en-Y gastric bypass surgery in women with PCOS (cases, n = 30) compared to women without PCOS (controls, n = 60) matched for baseline age, body mass index (BMI) and presence or absence of type 2 diabetes (T2D). Data shown represent mean values. RESULTS: At 24 months after surgery the 90 participants (age 36.1 years) experienced significant reductions in BMI (53.4 vs. 34.9 kg/m2, p < 0.0001), glycated haemoglobin (HbA1c) in 21 women with T2D (68.2 vs. 38.7 mmol/mol, p < 0.0001) and blood pressure (BP) in 29 women with hypertension (144/91 vs. 129/83 mmHg, p < 0.01), while obstructive sleep apnoea (OSA) resolved in 88.0% of the 25 affected patients. Women with PCOS compared to women without PCOS achieved equivalent reductions in percentage total weight loss (32.6% vs. 32.6% at 12 months and 34.8% vs. 36.1% at 24 months) and HbA1c (T2D subgroup; 38.3 vs. 41.6 mmol/mol at 12 months and 37.0 vs. 39.6 mmol/mol at 24 months) and comparable improvement in BP (hypertension subgroup) and resolution of OSA (87.5% vs. 88.2% at 24 months). CONCLUSION: In women with PCOS with morbid obesity, gastric bypass resulted in significant weight loss and metabolic outcomes similar to women without PCOS.

Health related quality of life following open versus minimally invasive total gastrectomy for cancer: Results from a randomized clinical trial.

INTRODUCTION: Minimally invasive techniques show improved short-term and comparable long-term outcomes compared to open techniques in the treatment of gastric cancer and improved survival has been seen with the implementation of multimodality treatment. Therefore, focus of research has shifted towards optimizing treatment regimens and improving quality of life. MATERIALS AND METHODS: A randomized trial was performed in thirteen hospitals in Europe. Patients were randomized between open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG) after neoadjuvant chemotherapy. This study investigated patient reported outcome measures (PROMs) on health-related quality of life (HRQoL) following OTG or MITG, using the Euro-Qol-5D (EQ-5D) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires, modules C30 and STO22. Due to multiple testing a p-value < 0.001 was deemed statistically significant. RESULTS: Between January 2015 and June 2018, 96 patients were included in this trial. Forty-nine patients were randomized to OTG and 47 to MITG. A response compliance of 80% was achieved for all PROMs. The EQ5D overall health score one year after surgery was 85 (60-90) in the open group and 68 (50-83.8) in the minimally invasive group (P = 0.049). The median EORTC-QLQ-C30 overall health score one year postoperatively was 83,3 (66,7-83,3) in the open group and 58,3 (35,4-66,7) in the minimally invasive group (P = 0.002). This was not statistically significant. CONCLUSION: No differences were observed between open total gastrectomy and minimally invasive total gastrectomy regarding HRQoL data, collected using the EQ-5D, EORTC QLQ-C30 and EORTC-QLQ-STO22 questionnaires.

Haemoglobin and Hematinic Status Before and After Bariatric Surgery over 4 years of Follow-Up.

PURPOSE: Bariatric surgery is associated with deficiencies of vitamins and minerals, and patients are routinely advised supplements postoperatively. We studied prevalence of vitamin B12, folate and iron deficiencies and anaemia before and after bariatric surgery over 4 years of follow-up. MATERIALS AND METHODS: We performed a retrospective cohort analysis of 353 people with obesity, including 257 (72.8%) women, who underwent gastric bypass (252, 71.4%) or sleeve gastrectomy (101, 28.6%) at our National Health Service bariatric centre in Northwest England. RESULTS: At baseline, mean (standard error) age was 46.0 (0.6) years, body mass index 53.1 (0.4) kg/m2, serum vitamin B12 400.2 (16.4) pg/L, folate 7.7 (0.2) µg/L, iron 12.0 (0.3) µmol/L, ferritin 118.3 (8.4) µg/L and haemoglobin 137.9 (0.8) g/L. Frequency of low vitamin B12 levels reduced from 7.5% preoperatively to 2.3% at 48 months (P < 0.038). Mean folate levels increased from baseline to 48 months by 5.3 µg/L (P < 0.001) but frequency of low folate levels increased from 4.7% preoperatively to 10.3% (P < 0.048). Ferritin levels increased from baseline to 48 months by 51.3 µg/L (P < 0.009). Frequency of low ferritin levels was greater in women (39.1%) than in men (8.9%) at baseline (P < 0.001) and throughout the study period. Haemoglobin was low in 4.6% of all patients at baseline with no significant change over the study period. CONCLUSION: There were notable rates of haematinic insufficiencies in bariatric surgical candidates preoperatively. Our study lends further support to regular supplementation with vitamin B12, folic acid, and iron in people undergoing bariatric surgery.

Open versus minimally invasive total gastrectomy after neoadjuvant chemotherapy: results of a European randomized trial.

BACKGROUND: Surgical resection with adequate lymphadenectomy is regarded the only curative option for gastric cancer. Regarding minimally invasive techniques, mainly Asian studies showed comparable oncological and short-term postoperative outcomes. The incidence of gastric cancer is lower in the Western population and patients often present with more advanced stages of disease. Therefore, the reproducibility of these Asian results in the Western population remains to be investigated. METHODS: A randomized trial was performed in thirteen hospitals in Europe. Patients with an indication for total gastrectomy who received neoadjuvant chemotherapy were eligible for inclusion and randomized between open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG). Primary outcome was oncological safety, measured as the number of resected lymph nodes and radicality. Secondary outcomes were postoperative complications, recovery and 1-year survival. RESULTS: Between January 2015 and June 2018, 96 patients were included in this trial. Forty-nine patients were randomized to OTG and 47 to MITG. The mean number of resected lymph nodes was 43.4 ± 17.3 in OTG and 41.7 ± 16.1 in MITG (p = 0.612). Forty-eight patients in the OTG group had a R0 resection and 44 patients in the MITG group (p = 0.617). One-year survival was 90.4% in OTG and 85.5% in MITG (p = 0.701). No significant differences were found regarding postoperative complications and recovery. CONCLUSION: These findings provide evidence that MITG after neoadjuvant therapy is not inferior regarding oncological quality of resection in comparison to OTG in Western patients with resectable gastric cancer. In addition, no differences in postoperative complications and recovery were seen.

Vitamin D Status After Gastric Bypass or Sleeve Gastrectomy over 4 Years of Follow-up.

BACKGROUND: Bariatric surgery for severe obesity can lead to micronutrient/vitamin deficiencies. AIMS: To study baseline and post-surgical prevalence of vitamin D deficiency in patients undergoing bariatric surgery. PARTICIPANTS AND SETTING: Patients undergoing bariatric surgery in a university teaching hospital in North West England. METHODS: We performed an observational cohort analysis of longitudinal data on vitamin D and related parameters in patients who underwent bariatric surgery. Patients were routinely recommended daily combined calcium and vitamin D supplementation post-surgery. RESULTS: We studied 460 patients who had completed at least 12 months post-operatively; mean (standard deviation) age was 48.0 (10.5) years, weight 144.7 (27.3) kg and body mass index 50.0 (7.6) kg/m2; 292 (63.5%) underwent gastric bypass and 168 (36.5%) sleeve gastrectomy. Vitamin D level was 33.1 (23.9) nmol/L at baseline, rising to 57.1 (23.1) nmol/L at 12 months post-surgery. Whereas 43.2% had vitamin D deficiency and 34.7% insufficiency preoperatively, 8.9% and 26.7% had deficiency and insufficiency, respectively, at 12 months with similar trends up to 4 years of follow-up. There were no significant differences between procedures or sexes in vitamin D levels or sufficiency rates. CONCLUSION: Vitamin D deficiency and insufficiency were prevalent pre-surgery and reduced significantly with routine supplementation post-surgery.

POSSUM and p-POSSUM overestimate morbidity and mortality in laparoscopic bariatric surgery.

BACKGROUND: Despite their wide use in surgical audit, the application of the Physiologic and Operative Severity Score for the enUmeration of Mortality and Morbidity (POSSUM) and the Portsmouth predictor of mortality (p-POSSUM) in bariatric surgery has been limited. The aim of this study was to evaluate the usefulness of POSSUM and p-POSSUM in bariatric comparative audit. METHODS: Data were retrospectively collected on consecutive patients who underwent laparoscopic gastric by-pass (LRYGB) and sleeve gastrectomy (SG) at a teaching institute. POSSUM and p-POSSUM equations were applied. The observed to expected ratios for morbidity and mortality were calculated. A Student's t test was performed to assess if a relationship could be found between the observed and the predicted outcomes. RESULTS: Between 2008 and 2013, 504 patients (370 female) with a mean (range) age of 46 (17-69) years underwent LRYGB (n = 383) and SG (n = 121). The operative morbidity was 10.9% and mortality was .2%. POSSUM overpredicted morbidity (30.56%), and no relationship between morbidity risk and the development of complications was found (P = .152). There was a grouping of patients in the low-risk mortality groups for both POSSUM and p-POSSUM. Both equations overpredicted mortality (5.95% and 1.62%, respectively). CONCLUSION: Both POSSUM and p-POSSUM equations overpredicted morbidity and mortality in this only study in the literature of modern bariatric practice that employed a large representative patient sample receiving the commonest procedures. A multicenter study is needed to address the low incidence of events and enable modification of those equations for use in bariatric surgical audit.