Safety of endoscopist-administered deep sedation with propofol in ASA III patients

Introduction: deep sedation controlled by the endoscopist is safe in patients with low anesthetic risk (ASA I-II). However, scarce evidence is available in patients with intermediate risk (ASA III).Objective: to evaluate the safety of deep sedation with propofol controlled by the usual endoscopy staff (endoscopist, nurse, assistant) in outpatients classified as ASA III and the risk factors for the occurrence of complications during deep sedation.Patients and methods: this observational and single-center cross-sectional study included consecutive patients undergoing non-complex procedures in which deep sedation was administered by the endoscopy staff. Patients were divided into group I (ASA = III) and group II (ASA < III).Results: a total of 562 patients were included and 80 (14.2 %) were in group I. Complications related to deep sedation were more frequent in group I (23.8 % vs 14.5 %; p = 0.036), mainly mild desaturations (13.8 % vs 7.5 %; p = 0.058). Emergency intervention or death were not registered. The adjusted analysis identified age as the only independent baseline risk factor for developing global adverse events.Conclusion: ASA III patients developed more sedation-related complications than ASA I-II patients. However, these complications were mild and did not prevent the correct performance of the procedure. (AU)

Safety of endoscopist-administered deep sedation with propofol in ASA III patients.

INTRODUCTION: deep sedation controlled by the endoscopist is safe in patients with low anesthetic risk (ASA I-II). However, scarce evidence is available in patients with intermediate risk (ASA III). OBJECTIVE: to evaluate the safety of deep sedation with propofol controlled by the usual endoscopy staff (endoscopist, nurse, assistant) in outpatients classified as ASA III and the risk factors for the occurrence of complications during deep sedation. PATIENTS AND METHODS: this observational and single-center cross-sectional study included consecutive patients undergoing non-complex procedures in which deep sedation was administered by the endoscopy staff. Patients were divided into group I (ASA = III) and group II (ASA < III). RESULTS: a total of 562 patients were included and 80 (14.2 %) were in group I. Complications related to deep sedation were more frequent in group I (23.8 % vs 14.5 %; p = 0.036), mainly mild desaturations (13.8 % vs 7.5 %; p = 0.058). Emergency intervention or death were not registered. The adjusted analysis identified age as the only independent baseline risk factor for developing global adverse events. CONCLUSION: ASA III patients developed more sedation-related complications than ASA I-II patients. However, these complications were mild and did not prevent the correct performance of the procedure.

Pancreatic Cancer Malnutrition and Pancreatic Exocrine Insufficiency in the Course of Chemotherapy in Unresectable Pancreatic Cancer.

Background: Malnutrition and cachexia are common in patients with advanced pancreatic ductal adenocarcinoma (PDAC) and have a significant influence on the tolerance and response to treatments. If timely identified, malnourished PDAC patients could be treated to increase their capacity to complete the planned treatments and, therefore, possibly, improve their efficacy. Aims: The aim of this study is to assess the impact of nutritional status, pancreatic exocrine insufficiency (PEI), and other clinical factors on patient outcomes in patients with advanced PDAC. Methods: PAncreatic Cancer MAlnutrition and Pancreatic Exocrine INsufficiency in the Course of Chemotherapy in Unresectable Pancreatic Cancer (PAC-MAIN) is an international multicenter prospective observational cohort study. The nutritional status will be determined by means of Mini-Nutritional Assessment score and laboratory blood tests. PEI will be defined by reduced fecal elastase levels. MAIN OUTCOME: adherence to planned chemotherapy in the first 12 weeks following the diagnosis, according to patients' baseline nutritional status and quantified and reported as "percent of standard chemotherapy dose delivered." SECONDARY OUTCOMES: rate of chemotherapy-related toxicity, progression-free survival, survival at 6 months, overall survival, quality of life, and the number of hospitalizations. ANALYSIS: chemotherapy dosing over the first 12 weeks of therapy (i.e., percent of chemotherapy received in the first 12 weeks, as defined above) will be compared between well-nourished and malnourished patients. SAMPLE SIZE: based on an expected percentage of chemotherapy delivered of 70% in well-nourished patients, with a type I error of 0.05 and a type II error of 0.20, a sample size of 93 patients per group will be required in case of a percentage difference of chemotherapy delivered of 20% between well-nourished and malnourished patients, 163 patients per group in case of a difference of 15% between the groups, and 356 patients per group in case of a 10% difference. Centers from Russia, Romania, Turkey, Spain, Serbia, and Italy will participate in the study upon Local Ethics Committee approval. Discussion: PAC-MAIN will provide insights into the role of malnutrition and PEI in the outcomes of PDAC. The study protocol was registered at clinicaltrials.gov as NCT04112836.

Pancreatic exocrine insufficiency and pancreatic enzyme replacement therapy in patients with advanced pancreatic cancer: A systematic review and meta-analysis.

BACKGROUND: Pancreatic cancer is the fourth leading cause of cancer mortality. Most patients are diagnosed with advanced pancreatic cancer, either at locally advanced or metastatic stages, and have a high rate of malnutrition and weight loss which are associated with poor outcomes. Pancreatic exocrine insufficiency is one of the causes of malnutrition and weight loss in these patients. The prevalence and clinical consequences of pancreatic exocrine insufficiency in advanced pancreatic cancer are poorly investigated with heterogeneous results. We sought to determine the prevalence and clinical consequences of pancreatic exocrine insufficiency and the effect of pancreatic enzyme replacement therapy in patients with advanced pancreatic cancer by systematic review and meta-analysis. METHODS: Scopus, Medline, and Embase were searched for cohort studies or randomised clinical trials reporting pancreatic exocrine insufficiency and/or the effect of pancreatic enzyme replacement therapy in patients with advanced pancreatic cancer. We considered pancreatic exocrine insufficiency as an abnormal result on direct and/or indirect pancreatic exocrine function tests. Pancreatic enzyme replacement therapy was evaluated by its effect on survival and quality of life in patients with advanced pancreatic cancer. RESULTS: A total of 11 studies were included; seven studies reported the prevalence of pancreatic exocrine insufficiency and seven the effect of pancreatic enzyme replacement therapy in advanced pancreatic cancer. The pooled prevalence of pancreatic exocrine insufficiency in advanced pancreatic cancer was 72% (95% confidence interval: 55-86%), being significantly higher when tumours were located in the pancreatic head (relative risk = 3.36, 1.07-10.54; p = 0.04) six studies investigated the impact of pancreatic enzyme replacement therapy on survival/quality of life. Pancreatic enzyme replacement therapy was associated with 3.8 months (95% confidence interval: 1.37-6.19) survival benefit. Patients receiving pancreatic enzyme replacement therapy had a trend towards a better quality of life.Conclusions The prevalence of pancreatic exocrine insufficiency in advanced pancreatic cancer is substantial and its treatment can improve the outcomes of these patients.

Endoscopic ultrasound-guided percutaneous endoscopic gastrostomy.

Percutaneous endoscopic gastrostomy (PEG) is the method of choice for feeding and nutritional support in patients with a normal gastrointestinal function who require long-term enteral nutrition. We report our experience regarding an alternative endoscopic ultrasound (EUS)-guided PEG technique. A retrospective clinical experience case series study was conducted from January 2019 to November 2019 at a tertiary center. Adult patients deemed unfit for conventional PEG due to absence of transillumination or previous gastric surgery were enrolled. An EUS target was created by filling a glove with saline and placing it in the abdomen. EUS was performed and the target identified from the stomach. The abdominal wall was punctured from the stomach and a guidewire was advanced. The guidewire was knotted to a string, which was passed into the stomach and drawn back through the mouth. The procedure was continued following the traditional technique. Four patients underwent EUS-PEG in our center during the study period. Mean age was 65 years and 50% were male. Two patients (50%) had a body mass index over 30. PEG indications were tongue malignancies (50%), cerebrovascular disease (25%) and dementia (25%). One patient had a Roux-en-Y gastric bypass and percutaneous endoscopic jejunostomy was performed. Technical success rate was 100% and no complications occurred. This case series shows that the EUS-guided PEG technique is a safe alternative in patients deemed unfit for conventional PEG.

Over-the-scope clip for acute esophageal variceal bleeding.

Over-the-scope clip (OTSC) has been reported to control non-variceal bleeding; however, the use of this device for acute variceal hemorrhage (AVH) is very limited. We report our experience regarding the use of OTSC in patients with AVH in terms of technical success and safety. A retrospective clinical experience case series study was conducted from October 2017 to June 2019 at two tertiary care centers. Adult patients with AVH as a result of small varices managed with OTSC after endoscopic band ligation (EBL) failure were enrolled. Standard gastroscope and OTSC 'type a' with a cap of 11 mm in diameter were used in all procedures. Total of five patients with chronic liver disease (Child-Pugh score ≤8) and portal hypertension (hepatic venous pressure gradient, mean 14.4 ± 1.3 mmHg) were included. Four of them presented collapse of the bleeding varix, and one had wall disruption associated with fibrosis secondary to prior banding. We were able to stop AVH in all patients without clip-related adverse events during a 30-day follow-up period. Two patients developed solid food dysphagia after 3 months of clip deployment that resolved after removal using a bipolar cutting device. Twin grasper or anchor were not used to aid or facilitate the approximation of opposite edges in any patient. No additional local therapies or new endoscopic session for variceal eradication were required. This case series shows preliminary success controlling AVH with OTSC after EBL failure in patients with small varices. Esophageal dysphagia may appear as a complication during follow up but it can be resolved by clip removal.

Food Tolerance and Quality of Alimentation Following Laparoscopic Sleeve Gastrectomy Calibrated with a 50-Fr Bougie: Long-Term Results.

BACKGROUND: Adjustable gastric banding and vertical banded gastroplasty are associated with the worst postoperative food tolerance of all bariatric techniques. However, food tolerance tends to improve over time. The aim of this study was to assess food tolerance and diet quality in patients undergoing a sleeve gastrectomy, 1 and 5 years after surgery. PATIENTS AND METHODS: A prospective observational study of all the morbidly obese patients undergoing laparoscopic sleeve gastrectomy was performed. Food tolerance was assessed using the Quality of Alimentation questionnaire validated in bariatric patients. RESULTS: Ninety-three patients were analyzed. One year after surgery, mean excess weight loss (EWL) was 81.1% ± 8.3%, and 5 years after surgery, mean EWL was 79.9% ± 6.4%. Preoperatively, 39.8% of patients perceived their eating patterns as good or excellent, 1 year after surgery, 79.6% and 5 years postoperatively, 86%. One year after surgery, the patients reported some difficulty in tolerance of rice, pasta, and red meat. Five years after surgery, these difficulties disappeared and very few patients just refer some tolerance difficulties with red meat. One year after surgery, 10% of the patients reported that they suffered postprandial vomiting often and 22% rarely. Five years postoperatively, only 8% of subjects describe rarely vomiting. CONCLUSION: After sleeve gastrectomy, the patients recognize an improvement in the quality of alimentation. During the first postoperative year, they present tolerance problems with rice, pasta, and red meat, and that disappeared 5 years after surgery.

Changes in Frequency Intake of Foods in Patients Undergoing Sleeve Gastrectomy and Following a Strict Dietary Control.

PURPOSE: Dietary intake and food preferences change after bariatric surgery, secondary to gastrointestinal symptoms and dietitian counseling. The aim of this study was to evaluate the changes in the frequency intake of different foods in patients undergoing sleeve gastrectomy and following a strict dietary control. PATIENTS AND METHODS: A prospective observational study of all the morbidly obese patients undergoing laparoscopic sleeve gastrectomy as bariatric procedure between 2007 and 2012 was performed. Dietary assessment was performed using the Alimentary Frequency Questionnaire 1991-2002, developed and validated by the Department of Epidemiology of Miguel Hernandez University (Elche, Alicante Spain). RESULTS: Ninety-three patients were included for analysis, 73 females and 20 males, with a mean preoperative BMI of 46.4 ± 7.9 kg/m2. One year after surgery, excess weight loss was 81.1 ± 8.3% and 5 years after surgery, 79.9 ± 6.4%. Total weight loss at 1 year was 38.8 ± 5.3% and at 5 years, 35.4 ± 4.9%. Postoperatively, a reduction in the intake of dairy products, red meat, deli meat products, shellfish, fried potatoes, sweets, rice, pasta, beer, and processed foods was observed. Vegetables, fruits, and legumes intake increased after surgery. In the first postoperative year, there was a slight intolerance to red meat, fruits, vegetables and legumes, dairy products, pasta, and rice that mostly disappeared 5 years after surgery. CONCLUSION: One year after sleeve gastrectomy, calibrated with a 50-French bougie, there are not important problems in the intake of foods a priori difficult to digest. These problems mostly disappeared 5 years after surgery. The decrease intake of other unhealthy foods is mostly based on the dietary counseling.

[Pre and postoperative adherence to Mediterranean-like diet and its effect on weight loss and cardiovascular risk factors after sleeve gastrectomy]. / Adherencia pre y postoperatoria a la dieta Mediterránea y su efecto sobre la pérdida de peso y el perfil lipídico en pacientes obesos mórbidos sometidos a gastrectomía vertical como procedimiento bariátrico.

PURPOSE: Even in the Mediterranean countries, the adherence to the Mediterranean diet is every day smaller. The aim of this study was to evaluate the adherence to Mediterranean diet of morbidly obese patients before and after undergoing a sleeve gastrectomy. MATERIALS AND METHODS: A prospective observational study of all the patients undergoing Laparoscopic Sleeve Gastrectomy (LSG) as bariatric technique between October 2010 and May 2012 was performed. All the patients completed the KIDMED index, before surgery and 1 year after the intervention. KIDMED index assessed the adherence to the Mediterranean diet. RESULTS: A total of 50 patients were included in the study. Before surgery, 30% of patients presented a poor adherence to Mediterranean diet, 64% an average adherence and 6% a good adherence, whereas 1 year after surgery 2% showed poor adherence, 58% an average adherence and 40% good adherence (p=0.02). A significant inverse correlation could be established between KIDMED score changes and weight loss (Spearman -0.357; p=0.008), total cholesterol (Spearman -0.442; p=0.003) and LDL-cholesterol (Spearman -0.464 p=0.002). A direct correlation could be established between KIDMED score and HDL-cholesterol increases (Spearman 0.562; p=0.001). CONCLUSIONS: Patients with better adherence to a Mediterranean diet showed greater weight loss and improvement of lipid profile 1 year after surgery.

Introducción: El cumplimiento de la dieta mediterránea es cada vez menor, incluso en países mediterráneos, a pesar de estar considerada como un ejemplo de dieta saludable. Objetivos: El objetivo principal de este trabajo fue evaluar la adherencia a la dieta mediterránea en pacientes obesos mórbidos antes y después de ser sometidos a una gastrectomía vertical como técnica bariátrica. Así mismo, se analizó también la influencia de la adherencia sobre la pérdida de peso conseguida y sobre la evolución de los factores de riesgo cardiovasculares. Material y métodos: Se realizó un estudio observacional prospectivo de todos los pacientes sometidos a una gastrectomía vertical entre octubre de 2010 y mayo de 2012. Los pacientes rellenaron un test KIDMED (evalúa la adherencia a la dieta mediterránea) antes de la operación y 1 año después de la misma. Resultados: Se incluyeron un total de 50 pacientes en el estudio. Antes de la operación, el 30% de los pacientes estudiados presentaban una baja adherencia a la dieta mediterránea, el 64% una adherencia moderada y sólo un 6% una buena adherencia. Al año de la intervención, sólo un 2% de los casos presentaban una baja adherencia, un 58% una adherencia moderada y un 40% una buena adherencia a la dieta mediterránea (p=0,02). Se estableció una correlación inversa entre el aumento de puntuación del test KIDMED (indicador de mayor adherencia a la dieta mediterránea) y la pérdida de peso (Spearman -0,357; p=0,008), el descenso en los valores de colesterol total (Spearman -0,442; p=0,003) y de LDL-colesterol (Spearman -0,464; p=0,002). Además, se observó una correlación directa entre el aumento de puntuación del test KIDMED y el incremento en los niveles de HDL-colesterol (Spearman 0,562; p=0,001). Conclusiones: Después de la operación, los pacientes cumplen mejor los patrones de dieta mediterránea. Aquellos pacientes con mejor adherencia a la misma, consiguieron una mayor pérdida de peso y una mejoría significativa del perfil lipídico.

Adherencia pre y postoperatoria a la dieta mediterránea y su efecto sobre la pérdida de peso y el perfil lipídico en pacientes obesos mórbidos sometidos a gastrectomía vertical como procedimiento bariátrico / Pre and postoperative adherence to mediterranean-like diet and its effect on weight loss and cardiovascular risk factors after sleeve gastrectomy

Introducción: El cumplimiento de la dieta mediterránea es cada vez menor, incluso en países mediterráneos, a pesar de estar considerada como un ejemplo de dieta saludable. Objetivos: El objetivo principal de este trabajo fue evaluar la adherencia a la dieta mediterránea en pacientes obesos mórbidos antes y después de ser sometidos a una gastrectomía vertical como técnica bariátrica. Así mismo, se analizó también la influencia de la adherencia sobre la pérdida de peso conseguida y sobre la evolución de los factores de riesgo cardiovasculares. Material y métodos: Se realizó un estudio observacional prospectivo de todos los pacientes sometidos a una gastrectomía vertical entre octubre de 2010 y mayo de 2012. Los pacientes rellenaron un test KIDMED (evalúa la adherencia a la dieta mediterránea) antes de la operación y 1 año después de la misma. Resultados: Se incluyeron un total de 50 pacientes en el estudio. Antes de la operación, el 30% de los pacientes estudiados presentaban una baja adherencia a la dieta mediterránea, el 64% una adherencia moderada y sólo un 6% una buena adherencia. Al año de la intervención, sólo un 2% de los casos presentaban una baja adherencia, un 58% una adherencia moderada y un 40% una buena adherencia a la dieta mediterránea (p=0,02). Se estableció una correlación inversa entre el aumento de puntuación del test KIDMED (indicador de mayor adherencia a la dieta mediterránea) y la pérdida de peso (Spearman -0,357; p=0,008), el descenso en los valores de colesterol total (Spearman -0,442; p=0,003) y de LDL-colesterol (Spearman -0,464; p=0,002). Además, se observó una correlación directa entre el aumento de puntuación del test KIDMED y el incremento en los niveles de HDL-colesterol (Spearman 0,562; p=0,001). Conclusiones: Después de la operación, los pacientes cumplen mejor los patrones de dieta mediterránea. Aquellos pacientes con mejor adherencia a la misma, consiguieron una mayor pérdida de peso y una mejoría significativa del perfil lipídico (AU)

Purpose: Even in the Mediterranean countries, the adherence to the Mediterranean diet is every day smaller. The aim of this study was to evaluate the adherence to Mediterranean diet of morbidly obese patients before and after undergoing a sleeve gastrectomy. Materials and methods: A prospective observational study of all the patients undergoing Laparoscopic Sleeve Gastrectomy (LSG) as bariatric technique between October 2010 and May 2012 was performed. All the patients completed the KIDMED index, before surgery and 1 year after the intervention. KIDMED index assessed the adherence to the Mediterranean diet. Results: A total of 50 patients were included in the study. Before surgery, 30% of patients presented a poor adherence to Mediterranean diet, 64% an average adherence and 6% a good adherence, whereas 1 year after surgery 2% showed poor adherence, 58% an average adherence and 40% good adherence (p=0.02). A significant inverse correlation could be established between KIDMED score changes and weight loss (Spearman -0.357; p=0.008), total cholesterol (Spearman -0.442; p=0.003) and LDL-cholesterol (Spearman -0.464 p=0.002). A direct correlation could be established between KIDMED score and HDL-cholesterol increases (Spearman 0.562; p=0.001). Conclusions: Patients with better adherence to a Mediterranean diet showed greater weight loss and improvement of lipid profile 1 year after surgery (AU)