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Phase II Trial of Neoadjuvant Chemotherapy, Chemoradiotherapy, and Laparoscopic Surgery with Selective Lateral Node Dissection for Poor-Risk Low Rectal Cancer.
Konishi, T, Shinozaki, E, Murofushi, K, Taguchi, S, Fukunaga, Y, Nagayama, S, Fujimoto, Y, Akiyoshi, T, Nagasaki, T, Suenaga, M, et al
Annals of surgical oncology. 2019;(8):2507-2513
Abstract
PURPOSE The aim of this study is to evaluate the safety and efficacy of induction modified 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus bevacizumab followed by S- 1-based chemoradiotherapy in magnetic resonance imaging (MRI)-defined poor-risk locally advanced low rectal cancer. PATIENTS AND METHODS This was a prospective phase II trial at a single comprehensive cancer center. The primary endpoint was the pathological complete response (pCR) rate. Eligible patients had clinical stage II-III low rectal adenocarcinoma with any of the following MRI-defined poor-risk features: circumferential resection margin (CRM) ≤ 1 mm, cT4, positive lateral nodes, mesorectal N2 disease, and/or requiring abdominoperineal resection. Patients received six cycles of mFOLFOX6 with 5 mg/kg bevacizumab followed by oral S-1 (80 mg/m2/day on days 1-14 and 22-35) plus radiotherapy (50.4 Gy). Surgery was conducted through a laparoscopic approach. Lateral node dissection was selectively added when the patient had enlarged lateral nodes. RESULTS A total of 43 patients were enrolled. Grade 3-4 adverse events occurred in nine patients during induction chemotherapy and in five patients during chemoradiotherapy. One patient declined surgery with a clinical complete response. Forty-two patients underwent surgery, and 16 had pCR [37.2%, 95% confidence interval (CI) 24.4-52.1%]. All underwent R0 resection without conversion, including combined resection of adjacent structures (n = 14) and lateral node dissection (n = 30). Clavien-Dindo grade 3-4 complications occurred in six patients (14.3%). With median follow-up of 52 months, six developed recurrences (lung n = 5, local n = 1; 3-year relapse-free survival 86.0%). CONCLUSIONS This study achieved a high pCR rate with favorable toxicity and postoperative complications in poor-risk locally advanced low rectal cancer. Multicenter study is warranted to evaluate this regimen.
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Comparison of postoperative lymphocytes and interleukins between laparoscopy-assisted and open radical gastrectomy for early gastric cancer.
Xia, X, Zhang, Z, Xu, J, Zhao, G, Yu, F
The Journal of international medical research. 2019;(1):303-310
Abstract
OBJECTIVE This study aimed to study the effects of laparoscopic-assisted radical gastrectomy (LAG) and open radical gastrectomy (OG) on immune function and inflammatory factors in patients with early gastric cancer. METHODS Seventy-five patients with pT1N0M0 gastric cancer in Ren Ji Hospital from August 2017 to January 2018 were studied. Lymphocytes subsets and interleukins were compared preoperatively and on the third postoperative day (POD3) and seventh postoperative day (POD7). RESULTS There were no significant differences in age, sex, body mass index, duration of the operation, estimated blood loss, total gastrectomy rate, postoperative first fluid diet, and the levels of preoperative lymphocytes subsets and interleukins between the two groups. The number of CD4+ T cells and the CD4+/CD8+ ratio in the LAG group were significantly higher than those in the OG group on POD3. However, the number of CD8+ T cells, and interleukin-6 and interleukin-8 levels in the LAG group were significantly lower than those in the OG group on POD3. CONCLUSIONS Laparoscopy can effectively reduce the levels of inflammatory factors and has less effect on the immune system than OG.
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Laparoscopic Roux-en-Y gastric bypass surgery influenced pharmacokinetics of several drugs given as a cocktail with the highest impact observed for CYP1A2, CYP2C8 and CYP2E1 substrates.
Puris, E, Pasanen, M, Ranta, VP, Gynther, M, Petsalo, A, Käkelä, P, Männistö, V, Pihlajamäki, J
Basic & clinical pharmacology & toxicology. 2019;(2):123-132
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Abstract
There is a lack of information about the changes in drug pharmacokinetics and cytochrome P450 (CYP) metabolism after bariatric surgery. Here, we investigated the effects of laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery on pharmacokinetics of nine drugs given simultaneously which may reveal changes in the activities of the main CYPs. Eight obese subjects undergoing LRYGB received an oral cocktail containing nine drugs, substrates of various CYPs: melatonin (CYP1A2), nicotine (CYP2A6), bupropion (CYP2B6), repaglinide (CYP2C8), losartan (CYP2C9), omeprazole (CYP2C19/CYP3A4), dextromethorphan (CYP2D6), chlorzoxazone (CYP2E1) and midazolam (CYP3A). The 6-hours pharmacokinetic profiles in serum and urine of each drug or corresponding metabolite as well as their metabolic ratios were compared before surgery with those at a median 1 year later. LRYGB exerted variable effects on the pharmacokinetics of these drugs. The geometric mean AUC0-6 (90% confidence interval) of melatonin, bupropion, repaglinide, chlorzoxazone and midazolam after LRYGB was 27 (19%-41%), 54 (43%-67%), 44 (29%-66%), 160 (129%-197%) and 74 (62%-90%) of the pre-surgery values, respectively. The pharmacokinetics of losartan, omeprazole and dextromethorphan did not change in response to surgery. Nicotine was not detected in serum, while geometric mean of AUC0-6 of its metabolite, cotinine, increased by 1.7 times after surgery. There were 3.6- and 1.3-fold increases in the AUC ratios of 6-hydroxymelatonin/melatonin and hydroxybupropion/bupropion, respectively. The cocktail revealed multiple pharmacokinetic changes occurring after LRYGB with the greatest effects observed for CYP1A2, CYP2C8 and CYP2E1 substrates. Future studies should be focused on CYP1A2, CYP2A6, CYP2C8 and CYP2B6 to clarify the changes in activities of these enzymes after LRYGB.
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The long-term effect of pregnancy on weight loss after sleeve gastrectomy.
Rottenstreich, A, Shufanieh, J, Kleinstern, G, Goldenshluger, A, Elchalal, U, Elazary, R
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2018;(10):1594-1599
Abstract
BACKGROUND Pregnancy outcomes after bariatric surgery have been addressed extensively; however, the impact of pregnancy on long-term outcomes after bariatric surgery has only been sparsely studied. OBJECTIVES We explored the effects of pregnancy on weight loss outcomes after laparoscopic sleeve gastrectomy (LSG). SETTING University hospital. METHODS A cross-sectional case-control study. Eighty women who became pregnant after LSG were matched by preoperative body mass index, age, and follow-up duration to 80 post-LSG patients who did not conceive after surgery (control group). RESULTS The median follow-up duration was 5.2 years for the study group and 5.3 years for the control group (P = .73). For the study group, the median time from surgery to conception was 508 (interquartile range 372-954) days and the median gestational weight gain was 9 (6-12) kg. Comparing the study with the control group, median percentage total weight loss was similar, 31% versus 30% (P = .77); as was percentage excess weight loss (EWL%) 72% versus 71% (P = .77). For the study group, a multivariable analysis showed EWL% at the end of follow-up to be directly correlated with the lowest EWL% achieved before pregnancy (β = .78, P < .0001), and inversely correlated with time lapsed from surgery (β = -.26, P < .0001); yet EWL% was not found to be associated with surgery-to-conception time interval, gestational weight gain, breastfeeding, co-morbidities, smoking, occupational status, physical activity, and dietary habits. CONCLUSIONS Pregnancy after LSG does not affect long-term weight results. Coupled with the positive reports of improved pregnancy outcomes after bariatric surgery, these data should reassure women who wish to conceive after surgery.
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The Effects on Obesity Related Peptides of Laparoscopic Gastric Band Applications in Morbidly Obese Patients.
Arica, PC, Aydin, S, Zengin, U, Kocael, A, Orhan, A, Zengin, K, Gelisgen, R, Taskin, M, Uzun, H
Journal of investigative surgery : the official journal of the Academy of Surgical Research. 2018;(2):89-95
Abstract
BACKGROUND The aim of this study was to examine the relationship between weight loss and resistin, apelin, chemerin, and visfatin after laparoscopic adjustable gastric banding (LAGB). METHODS The study group consisted of 19 patients who were operated on for morbid obesity (BMI: 48.7 ± 6.6 kg/m2), and 22 healthy, normal-weight (BMI: 22.9 ± 2.5 kg/m2) subjects formed the control group. We obtained blood samples from the study subjects at three different times: before undergoing surgery and at one month and 6 months after surgery. Blood was obtained once from the control group. RESULTS Significant weight loss was achieved at one and 6 months after surgery. Plasma levels of apelin, resistin, chemerin, and visfatin were higher in morbidly obese patients compared with the control group. Obesity-related peptides decreased one month and 6 months after surgery. CONCLUSIONS Elevated plasma resistin, apelin, chemerin, and visfatin levels in morbidly obese patients are gradually reduced after weight loss. According to these findings, LAGB surgery is found to be an important and efficient means for morbidly obese patients both to lose weight and to develop a better metabolic risk profile in a short time period.
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Effect of laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy on fasting gastrointestinal and pancreatic peptide hormones: A prospective nonrandomized trial.
Yang, J, Gao, Z, Williams, DB, Wang, C, Lee, S, Zhou, X, Qiu, P
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2018;(10):1521-1529
Abstract
BACKGROUND Changes in gastrointestinal and pancreatic hormones may play a role in promoting long-term weight reduction and improved glucose metabolism after sleeve gastrectomy and Roux-en-Y gastric bypass. However, few studies have examined the metabolic and endocrine effects of these procedures in Mainland China. OBJECTIVES To compare the effects of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) on gastrointestinal and pancreatic peptide hormones. SETTING University hospital, China. METHODS A nonrandomized prospective study was conducted in Chinese obese patients undergoing LSG or LRYGB. Of 20 patients in this study, 10 underwent LSG, and 10 underwent LRYGB. Fasting plasma levels of insulin, glucagon, ghrelin, gastric inhibitory peptide, peptide YY, glucagon-like peptide (GLP)-1, and GLP-2 were measured preoperatively and at 1, 3, 6, and 12 months after surgery. This trial was registered at www.clinicaltrials.gov (NCT02963662). RESULTS During the first year after both operations, mean body mass index and fasting insulin levels steadily decreased at all intervals. Fasting plasma glucose levels significantly decreased at 1 month after surgery, then remained stable in both groups. Glucagon levels significantly decreased at 1, 3, and 6 months after surgery in both groups, but returned to baseline at 12 months. Fasting GLP-1 and peptide YY significantly increased in both groups, but more so after LRYGB. However, GLP-2 did not change in either group. Ghrelin levels significantly decreased after LSG, but not after LRYGB. Gastric inhibitory peptide levels decreased after LRYGB but not after LSG. CONCLUSIONS LSG and LRYGB resulted in significant and distinct changes in multiple gastrointestinal and pancreatic peptide hormones that are important regulators of obesity and metabolic health.
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Randomized, controlled trial comparing clinical outcomes of 3D and 2D laparoscopic surgery for gastric cancer: an interim report.
Lu, J, Zheng, CH, Zheng, HL, Li, P, Xie, JW, Wang, JB, Lin, JX, Chen, QY, Cao, LL, Lin, M, et al
Surgical endoscopy. 2017;(7):2939-2945
Abstract
OBJECTIVE In this study, we evaluated the short-term outcomes following three-dimensional (3D) or two-dimensional (2D) laparoscopic surgery for patients with gastric cancer. BACKGROUND There is a lack of prospective evidence regarding the safety and efficacy of 3D versus 2D laparoscopic surgery for patients with gastric cancer. Therefore, we conducted a phase III single-center, prospective, randomized, controlled trial to compare 3D and 2D laparoscopic surgery for patients with gastric cancer. METHODS We compared operation time, intraoperative blood loss, number of lymph node dissections, morbidity, and mortality between the 3D and 2D groups following laparoscopic surgery for gastric cancer. The study is registered at ClinicalTrials.gov with ID number NCT02327481. RESULTS A total of 228 patients were randomized (3D group 115 cases; 2D group 113 cases) between January 1, 2015 and September 1, 2015. Seven patients who underwent exploratory operations were excluded. Finally, a total of 221 patients were analyzed (3D group 109 cases, 2D group 112 cases). There were no significant differences between the two groups regarding the clinical pathological characteristics, operating time (3D vs. 2D, 184 ± 36 vs. 178 ± 37 min, P = 0.288), number of lymph node dissections (36 ± 14 vs. 37 ± 13, P = 0.698), time to first ambulation (2.27 ± 1.60 vs. 2.04 ± 0.84, P = 0.18), flatus (3.89 ± 1.49 vs. 3.69 ± 1.12, P = 0.255), liquid diet (4.88 ± 1.88 vs. 4.79 ± 1.57, P = 0.684), or duration of postoperative hospital stay (12.52 ± 4.83 vs. 12.63 ± 7.32, P = 0.903). The postoperative complication rates of the 3D and 2D groups were 18.3 and 16.1%, respectively, P = 0.723. No patients died during the postoperative hospital stay. However, the intraoperative blood loss in the 3D group was significantly lower than the 2D group (58 ± 75 vs. 78 ± 72 ml, P = 0.047). CONCLUSION There was no significant difference in operation time and number of lymph node harvested between the 3D and 2D groups; however, 3D laparoscopic surgery may reduce the intraoperative blood loss compared to 2D procedure. Therefore, we conclude that this trial is safe and is thus ongoing.
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Bile acids synthesis decreases after laparoscopic sleeve gastrectomy.
Escalona, A, Muñoz, R, Irribarra, V, Solari, S, Allende, F, Francisco Miquel, J
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2016;(4):763-769
Abstract
BACKGROUND Bariatric surgery is the most effective treatment alternative in morbid obesity. The mechanisms contributing to these benefits remain poorly understood. Bile acids (BAs) are mediators of different regulatory functions in glucose and cholesterol homeostasis and energy expenditure. Recent evidence suggests that BAs are critically important for the beneficial effects of sleeve gastrectomy (SG). OBJECTIVES The aim of this study was to evaluate the effect of SG on BA synthesis. SETTING University Hospital. Santiago, Chile. METHODS Obese patients were evaluated before and after SG (1, 3, 6, and 12 months). BA synthesis was evaluated through the serum marker, 7 α-hydroxy-4-cholesten-3-one (C4). Primary and secondary BA and C4 were determined by high performance liquid chromatography coupled with tandem mass spectrometry detection (HPLC-MS/MS). RESULTS From June 2013 to January 2014, 19 patients (age 37.6±7.8 years; BMI 35.8±3.5 kg/m(2); 79% female) were included in this study. Mean weight loss at 1, 3, 6, and 12 months was 11.3, 17.5, 23.6, and 25.4 kg, respectively, equivalent to 11.8, 18.6, 24.8, and 26.9 of total body water percentage (%TBW) (P<.0001), respectively and 43.2, 68.2, 91, and 98.8 of percentage of excess weight loss (%EWL), respectively (P<.001). Serum C4 levels at baseline, 1, 3, 6, and 12 months were 23.4±21.1, 4.9±8.2, 8.7±12.1, 13.8±12.9, and 18.8±16.8 ng/mL (P<.0001), respectively. Fibroblast growth factor 19 (FGF19) levels at baseline, 1, 3, 6, and 12 months were 71±33.3, 130.5±66.2, 117.8±57.2, 134.6±91.7, and 124.3±85.9 pg/mL (P = .019), respectively. CONCLUSION Serum levels of C4 decrease after SG, indicating a reduction in the synthesis of BA. FGF19 may play a role in decreasing BA synthesis. Further studies are necessary to characterize the effect of bariatric surgery on BA homeostasis.
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Predictors of weight loss after laparoscopic gastric plication: a prospective study.
Talebpour, A, Heidari, R, Zeinoddini, A, Talebpour, M
Journal of laparoendoscopic & advanced surgical techniques. Part A. 2015;(3):177-81
Abstract
INTRODUCTION Laparoscopic gastric plication (LGP) is a bariatric procedure for the treatment of morbid obesity that has recently increased in popularity. Herein, the predictors of weight loss following LGP are investigated. PATIENTS AND METHODS This prospective study was performed on cases performed by a single surgeon between 2000 and 2011. The association between nine independent variables and ideal weight loss (percentage of excess weight loss [%EWL] ≥80%) at 24 months postoperatively was assessed in 330 patients who underwent LGP. The studied variables were as follows: age at surgery, gender, preoperative body mass index, preoperative comorbidities, marital status (single versus married), employment status (employed versus unemployed), family support in helping the patient to engage in physical activities and continue on a healthy diet (never/a little versus sometimes/a lot), the experience of pain or gastroesophageal reflux during or after eating (yes or no), and participation in support groups following LGP (yes or no). RESULTS Ideal weight loss (%EWL ≥80%) was achieved in 60 patients, and %EWL <80% (suboptimal weight loss) occurred in 270 patients. Being single, female, and of younger age and participation in group meetings were significantly associated with experiencing ideal weight loss at 24 months, postoperatively. However, no significant difference was observed between the two groups in terms of preoperative body mass index, comorbidities, employment, a relative being a coworker, and the experience of pain or gastroesophageal reflux after eating. CONCLUSIONS This study identified predictor factors positively associated with ideal weight loss. These results would aid surgeons in better patient selection and identification of patients requiring more careful follow-up. In addition, it provides patients with more realistic assessment of potential outcome of the procedure.
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Short-term results of single-port sleeve gastrectomy in adolescents with severe obesity.
Pourcher, G, De Filippo, G, Ferretti, S, Piquard, C, Dagher, I, Bougnères, P
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2015;(1):65-9
Abstract
BACKGROUND Dietary and lifestyle modifications, which are commonly proposed to overweight or obese youth, lack efficacy in individuals who are severely obese. Early results with bariatric procedures in obese adolescents suggest that weight loss and safety are comparable or better than seen in adults. One of these procedures, laparoscopic sleeve gastrectomy, is commonly performed using multiple ports. METHODS We selected single-port sleeve gastrectomy (SPSG) as a minimally invasive surgery to be tested in severely obese adolescents. Prospective clinical and biochemical data were collected from 16 young severely obese patients who underwent SPSG. The setting was a university hospital. RESULTS The mean age of the cohort was 17.8 years (12 girls, 4 boys). The individuals' average weight was 125.5 kg and their average body mass index was 45.3 kg/m(2). All patients were insulin-resistant and 6 showed hypertriglyceridemia. The median operating time was 66 minutes, and there were no intraoperative complications. No conversion to open surgery was required. No patient required additional trocars and no patient had postoperative complications. The median hospital stay was 3 days. After a one-year follow-up, the average weight decrease was 40.3 kg, resulting in a decrease in excess weight loss by 70.61%. Insulin-resistance decreased in 16/16 patients and hypertriglyceridemia decreased in 5/6 patients. CONCLUSION SPSG seems safe and effective in the short term in severely obese adolescents.