RESUMO
OBJECTIVE: To evaluate safety, weight loss, and cardiometabolic changes in obese subjects implanted with the duodenal-jejunal bypass liner (DJBL) for 1 year. BACKGROUND: The DJBL is an endoscopic implant that mimics the duodenal-jejunal bypass component of the Roux-en-Y gastric bypass. Previous reports have shown significant weight loss and improvement in type 2 diabetes for up to 6 months. METHODS: Morbidly obese subjects were enrolled in a single arm, open label, prospective trial and implanted with the DJBL. Primary endpoints included safety and weight change from baseline to week 52. Secondary endpoints included changes in waist circumference, blood pressure, lipids, glycemic control, and metabolic syndrome. RESULTS: The DJBL was implanted endoscopically in 39 of 42 subjects (age: 36 ± 10 years; 80% female; weight: 109 ± 18 kg; BMI: 43.7 ± 5.9 kg/m); 24 completed 52 weeks of follow-up. Three subjects could not be implanted due to short duodenal bulb. Implantation time was 24 ± 2 minutes. There were no procedure-related complications and there were 15 early endoscopic removals. In the 52-week completer population, total body weight change from baseline was -22.1 ± 2.1 kg (P < 0.0001) corresponding to 19.9 ± 1.8% of total body weight and 47.0 ± 4.4% excess of weight loss. There were also significant improvements in waist circumference, blood pressure, total and low-density lipoprotein cholesterol, triglycerides, and fasting glucose. CONCLUSIONS: The DJBL is safe when implanted for 1 year, and results in significant weight loss and improvements in cardiometabolic risk factors. These results suggest that this device may be suitable for the treatment of morbid obesity and its related comorbidities. This study was registered at www.clinicaltrials.gov (NCT00985491).
Assuntos
Cirurgia Bariátrica/instrumentação , Doenças Metabólicas/cirurgia , Obesidade Mórbida/cirurgia , Próteses e Implantes , Redução de Peso , Adulto , Diabetes Mellitus Tipo 2/cirurgia , Duodeno/cirurgia , Feminino , Cardiopatias/fisiopatologia , Cardiopatias/cirurgia , Humanos , Jejuno/cirurgia , Masculino , Doenças Metabólicas/fisiopatologia , Pessoa de Meia-Idade , Obesidade Mórbida/metabolismo , Obesidade Mórbida/fisiopatologia , Estudos Prospectivos , Implantação de PróteseRESUMO
INTRODUCTION: The application of laparoscopic gastric surgery has rapidly increased for the treatment of early gastric cancer. However, laparoscopic gastrectomy for advanced tumor remains controversial, particularly in terms of oncologic outcomes. This study was designed to compare 3-year survival of laparoscopic versus open curative gastrectomy in early and advanced gastric cancer. METHODS: This was a retrospective matched cohort study. We included patients between 2003 and 2010 with an R0 resection. A totally laparoscopic technique was used and D2 lymph node dissection was practiced routinely. We performed an intracorporeal hand-sewn esophagojejunostomy in all laparoscopic total gastrectomy cases. We matched all laparoscopic cases 1:1 with open cases according to TNM AJCC seventh edition. We used Mann-Whitney or t test and Chi-square test to compare both groups. Kaplan-Meier analysis with log-rank test was performed to compare survival. RESULTS: We included 31 open and 31 laparoscopic cases (mean age 63 ± 14 years; 66% males). Both groups were identical in type of gastrectomy (71% total and 29% subtotal). There were no statistical difference between laparoscopic and open groups in age, sex, N category, tumor location and size, histological differentiation, and T category (48% T1, 13% T2, 16% T3, and 23% T4 in both groups), with 48% early and 52% advanced tumors. The median number of resected lymph nodes was similar: 35 (23-53) for laparoscopic and 39 (23-45) for open cases (P = 0.81). The median follow-up was 50 months. The overall 3-year survival was 82% for laparoscopic surgery and 87% for the open surgery group (P = 0.56). There were no difference in 3-year survival for the laparoscopic versus the open surgery groups for advanced tumors (74 vs. 75%, P = 0.88), N+ tumors (73 vs. 73%, P = 0.99) and for the different AJCC stages (stage 1: 94 vs. 100%, stage 2: 89 vs. 82%, and stage 3: 50 vs. 50%, P = 0.32, 0.83, and 0.98 respectively). CONCLUSIONS: In this preliminary report, with 52% of advanced tumor, the 3-year overall and stage-by-stage survival was comparable for laparoscopic and open curative gastrectomy.