Extensive peritoneal lavage after curative gastrectomy for gastric cancer (EXPEL): study protocol of an international multicentre randomised controlled trial.

Peritoneal recurrence after gastrectomy for gastric cancer is common and the prognosis is dismal. Recent evidence suggests that extensive peritoneal lavage with large volume of normal saline after surgery before abdominal closure can reduce the risk of peritoneal recurrence and improve overall survival. This study aims to evaluate the benefit of extensive intraoperative peritoneal lavage. This is a prospective, open-label, multicentre randomised controlled trial involving 15 international centres in China, Korea, Japan, Malaysia and Singapore. Patients with cT3/4 stomach cancer undergoing curative resection are randomised to either extensive peritoneal lavage (10 l of saline) or standard lavage (≤2 l of saline). The primary outcome is overall survival and secondary outcomes include disease-free survival and peritoneal recurrence. The minimum sample size is 600 subjects with 300 per arm completing 3 years follow-up. The data will be analysed on an intention-to-treat basis, assuming a two-sided test with a 5% level of significance.

Safety, pharmacokinetics and tissue penetration of PIPAC paclitaxel in a swine model.

INTRODUCTION: Peritoneal carcinomatosis is difficult to treat. Pressurized Intra-Peritoneal Aerosolised Chemotherapy (PIPAC) is a novel method of delivering chemotherapy to the peritoneal cavity, aiming for homogenous and deeper drug distribution. To date, limited chemotherapeutics have been used with promising results. Here, we evaluate the pharmacokinetics, peritoneal tissue drug concentration, penetration, and short-term safety of PIPAC using solvent-based paclitaxel in swine to guide clinical trials. MATERIALS AND METHODS: PIPAC solvent-based paclitaxel was administered at 60, 30, and 15mg/m2 for 3 cohorts. Each PIPAC procedure was followed by intravenous (IV) administration of the same dose of solvent-based paclitaxel on Day 7, serving as control for pharmacokinetic comparison in the same pig. Safety and toxicity were evaluated by clinical assessment, blood counts and biochemistry. Blood samples were taken for pharmacokinetic analysis. Peritoneal biopsies were taken to measure tissue paclitaxel concentrations and distribution. RESULTS: 12 Yorkshire x Landrace pigs underwent trial procedures. With PIPAC, there was linear pharmacokinetics and lower systemic exposure to paclitaxel compared to IV administration. MALDI-MSI demonstrated concentration of paclitaxel at the peritoneal surface, with estimated 2 mm penetration. PIPAC paclitaxel had favorable toxicity profile. The most significant adverse event was neutropenia which was dose dependent, with absolute neutrophil count <1.0 × 103/µL seen at the highest dose. One pig developed grade 2 hypersensitivity reaction during IV infusion and one death occurred during the PIPAC procedure, likely from anaphylaxis; these are known potential adverse events mandating standard precautions and monitoring. CONCLUSION: PIPAC paclitaxel at 15mg/m2 may be considered for a Phase I study.

Is Laparoscopic Sleeve Gastrectomy for Asian Super Obese a Safe and Effective Procedure?

INTRODUCTION: Outcomes of bariatric surgery for super obese Asians are not well reported. We aimed to compare short-term outcomes of laparoscopic sleeve gastrectomy (LSG) in Asian patients with body mass index (BMI) <47.5 kg/m2 to those with BMI •••••• ≥47.5 kg/m2. MATERIALS AND METHODS: A total of 272 patients from Singapore university hospital who underwent LSG from 2008 to 2015 with a follow-up of at least 6 months were included in the study. Primary endpoint was weight loss at 1-year and 3-years. Morbid obesity (Group 1, G1) was defined as BMI <47.5 kg/m2 and super obesity (Group2, G2) was defined as BMI ≥47.5 kg/m2. RESULTS: There were 215 patients in G1 and 57 patients in G2 (mean preoperative weight: 107.3 kg and 146.8 kg; mean follow-up: 27.9 and 26.8 months, respectively). Mean total weight loss at 3-year of 41.9 kg for G2 was significantly higher (P = 0.003) than 27.2 kg for G1. Mean percentage excess weight loss (EWL) did not differ at 3-years. There was no difference in operating time, blood loss, length of stay, 30-day morbidity and readmission. There were no conversions and mortality in both groups. Remission of herpertension (P - 0.001) and dyslipidaemia (P = 0.038) were significantly associated with achieving EWL percentage (%EWL) >50 in G1. CONCLUSION: LSG is an equally safe and effective operation in Asians with BMI ≥47.5 kg/m2 when compare to patients with BMI <47.5 kg/m2 in achieving significant weight loss and improvement in comorbidities. Super obese lose more weight but have lower %EWL.

Laparoscopic sleeve gastrectomy for morbidly obese adolescents in Singapore.

INTRODUCTION: Laparoscopic sleeve gastrectomy (LSG) outcomes among adolescents and factors associated with adolescent obesity in Singapore were evaluated. METHODS: Prospectively collected data of patients aged 16-19 years who underwent LSG was retrospectively reviewed. A lifestyle questionnaire, Berlin and Epworth scores, and Patient Health Questionnaire-9 scores were collected. Preoperative anthropometrics, comorbidities, weight loss and body composition outcomes were recorded. RESULTS: Among 208 LSGs, 13 (6.3%) were performed on obese adolescents. Mean age and body mass index (BMI) at first presentation were 19.1 ± 0.9 (range 16.8-19.8) years and 46.2 ± 6.3 (range 36-57) kg/m2, respectively. There was family history of obesity (n = 7) and regular consumption of high-calorie drinks (n = 12). Most patients had comorbidities (n = 12), including hypertension (n = 5), asthma (n = 4), diabetes mellitus (n = 3), hernia (n = 3) and obstructive sleep apnoea requiring continuous positive airway pressure support (n = 3). At one year, excess weight loss was 64.3% ± 34.7% (range 21.8%-101.5%), while BMI and fat mass dropped to 31.2 ± 7.6 (range 23-40) kg/m2 and 17.4 kg, respectively. Pain score was 2/10 at 24 hours after surgery. Mean postoperative stay was 2.7 days. No complications or readmissions occurred. Remission of diabetes mellitus and hypertension was reported in two of three and four of five adolescents, respectively, within one year of surgery. CONCLUSION: LSG is a safe option for adolescents with good short-term weight loss outcomes and remission of metabolic comorbid conditions.

Attitudes and Concerns of Diabetic Patients towards Bariatric Surgery as Treatment of Diabetes.

INTRODUCTION: Bariatric surgery is increasingly recognised as an effective treatment for type 2 diabetes that significantly improves glycaemic control, even achieving remission. This study examined perceptions and concerns of diabetic patients towards bariatric surgery as a treatment option for diabetes. MATERIALS AND METHODS: A total of 150 patients were recruited from a specialised diabetic outpatient clinic and completed a questionnaire (items were rated on a Likert scale from slightly important [lowest score of 1] to extremely important [maximum score of 5]). Logistic regression was performed to identify factors influencing decision for surgery. RESULTS: The 74 males and 76 females had mean age of 50 (range 20 to 78) and body mass index (BMI) of 29.6 kg/m2 (range 18.1 to 51); 61% considered surgery favourably. Predictive factors for interest in surgery: higher educational levels (OR = 2.3; 95% CI, 1.2 to 4.4), duration of diabetes (OR = 0.4; 95% CI, 0.2 to 1.0) and use of insulin (OR = 2.1; 95% CI, 1.1 to 4.1). Reasons for surgery: desire for remission (Likert scale 4.7 ± 0.7), to prevent complications (Likert scale 4.5 ± 0.9) and to reduce medications (Likert scale 4.3 ± 1.1). For those not keen on surgery, main reasons were fear of surgery (Likert scale 4 ± 1.5) and satisfaction with current therapy (Likert scale 3.7 ± 1.6). CONCLUSION: Many diabetic patients would consider surgery as an option to improve their metabolic disorder (greater interest in patients with higher educational levels, currently using insulin and with shorter duration of diabetes). Surgical complications, length of recovery and duration of benefits were the main concerns.

Connection tubing causing small bowel obstruction and colonic erosion as a rare complication after laparoscopic gastric banding: a case report.

INTRODUCTION: Laparoscopic adjustable gastric banding is the most frequently performed bariatric procedure for the treatment of morbid obesity and is associated with low morbidity and mortality. Complications related to obesity surgery are rare and their presentation is often non-specific. Thus, it is highly important for physicians who are practising bariatric surgery to be aware of complications described in single-case studies or series when they come across similar complications even years after the primary bariatric operation. CASE PRESENTATION: We report the case of a 47-year-old Malay woman who was admitted with symptoms and signs suggesting intestinal obstruction five years after gastric band placement. CONCLUSIONS: In our patient, the band connection wire tube was the cause of both small bowel obstruction and colonic erosion. Computed axial tomography is the cornerstone of the investigation of such patients. After surgical removal of the connecting tube, our patient recovered without sequelae.