Manoel Galvao Neto

First human experience with endoscopically delivered and retrieved duodenal-jejunal bypass sleeve

BACKGROUND We report the first human experience with an endoscopic duodenal-jejunal bypass sleeve (DJBS) in a community hospital. METHODS The DJBS is a 60-cm sleeve anchored in the duodenum to create a duodenal-jejunal bypass. In a 12-patient prospective, open-label, single-center, 12-week study, the device was endoscopically implanted, left in situ, and retrieved. The study included 5 men and 7 women, with a mean body mass index of 43 kg/m(2). Of the 12 patients, 4 had type 2 diabetes. The primary endpoints were the incidence and severity of adverse events. The secondary outcomes included the percentage of excess weight loss and changes in co-morbid status. RESULTS The DJBS was endoscopically delivered and retrieved in all patients (mean implant/explant time of 26.6 and 43.3 min, respectively). Of the 12 patients, 10 were able to maintain the device for 12 weeks and 2 underwent explantation after 9 days secondary to poor device placement. Several self-limited adverse events were possibly or definitely related to the device, including 6 episodes of abdominal pain, 18 of nausea, and 16 of vomiting, mainly within 2 weeks of implantation. Two partial pharyngeal tears occurred during explantation. Implant site inflammation was encountered in all patients. No device-related event was considered severe. The average percentage of excess weight loss for the 10 patients with the device in place for 12 weeks was 23.6%, with all patients achieving at least 10% excess weight loss. All 4 diabetic patients had normal fasting plasma glucose levels without hypoglycemic medication for the entire 12 weeks. Of these 4 patients, 3 had decreased hemoglobin A(1c) of > or =.5% by week 12. CONCLUSION The DJBS can be safely delivered and removed endoscopically and left in situ for 12 weeks. The device had a favorable safety and encouraging efficacy profile. Randomized prospective trials are warranted.

International multicenter trial on clinical natural orifice surgery--NOTES IMTN study: preliminary results of 362 patients.

Objectives: Natural orifice translumenal endoscopic surgery (NOTES) is evolving as a promising alternative for abdominal surgery. IMTN Registry was designed to prospectively document early results of natural orifice surgery among a large group of clinical cases. Methods: Sixteen centers from 9 countries were approved to participate in the study, based on study protocol requirements and local institutional review board approval. Transgastric and transvaginal endoscopic natural orifice surgery was clinically applied in 362 patients. Intraoperative and postoperative parameters were prospectively documented. Results: Mean operative time for transvaginal cholecystectomy was 96 minutes, compared with 111 minute for transgastric cholecystectomy. A general complication rate of 8.84% was recorded (grade I-II representing 5.8%, grade III-IV representing 3.04%). No requirement for any analgesia was found in one fourth of cholecystectomy and appendectomy patients. Conclusions: Results of clinical applications of NOTES in the IMTN Study showed the feasibility of different methods of this new minimally invasive alternative for laparoscopic and open surgery.

Open label, prospective, randomized controlled trial of an endoscopic duodenal-jejunal bypass sleeve versus low calorie diet for pre-operative weight loss in bariatric surgery

BackgroundThe duodenal-jejunal bypass sleeve (DJBS) has been shown to achieve a completely endoscopic duodenal exclusion without the need for stapling. This report is the first randomized controlled trial for weight loss.MethodsIn a 12-week, prospective, randomized study, subjects received either a low fat diet and the DJBS or a low fat diet control (no device). Twenty-five patients were implanted with the device and 14 received the control. The groups were demographically similar. Both groups received counseling at baseline only, which consisted of a low calorie diet, and exercise/behavior modification advice. No additional counseling occurred in either group. Measurements included starting and monthly body weight and serum blood tests. The device group also had a plain abdominal film post implant, a monthly KUB and a 4-week post explant EGD.ResultsTwenty device (80%) subjects maintained the DJBS without a significant adverse event for the 12-week duration. At 12 weeks, the mean excess weight loss was 22% and 5% for the device and control groups, respectively (p < 0.001). Five subjects (20%) were endoscopically explanted early secondary to upper GI (UGI) bleeding (n = 3), anchor migration (n = 1) and sleeve obstruction (n = 1). The UGI bleeding occurred at a mean of 13.8 days post implant. EGD was performed in each of these cases with no distinct bleeding source identified. No blood transfusion was required. The migration occurred on day 47 and manifested as abdominal pain. The subject with the sleeve obstruction presented with abdominal pain and vomiting on day 30. Eight subjects (40%) underwent the 4 week post explant EGD at which time mild degrees of residual duodenal inflammation was noted.ConclusionThe DJBS achieves noninvasive duodenal exclusion and short term weight loss efficacy. Longer term randomized controlled sham trials for weight loss and treatment of T2DM are underway.

Metabolic Improvements in Obese Type 2 Diabetes Subjects Implanted for 1 Year with an Endoscopically Deployed Duodenal–Jejunal Bypass Liner

BACKGROUND The purpose of this study was to evaluate the effect of the duodenal-jejunal bypass liner (DJBL), a 60-cm, impermeable fluoropolymer liner anchored in the duodenum to create a duodenal-jejunal bypass, on metabolic parameters in obese subjects with type 2 diabetes. METHODS Twenty-two subjects (mean age, 46.2±10.5 years) with type 2 diabetes and a body mass index between 40 and 60 kg/m(2) (mean body mass index, 44.8±7.4 kg/m(2)) were enrolled in this 52-week, prospective, open-label clinical trial. Endoscopic device implantation was performed with the patient under general anesthesia, and the subjects were examined periodically during the next 52 weeks. Primary end points included changes in fasting blood glucose and insulin levels and changes in hemoglobin A1c (HbA1c). The DJBL was removed endoscopically at the end of the study. RESULTS Thirteen subjects completed the 52-week study, and the mean duration of the implant period for all subjects was 41.9±3.2 weeks. Reasons for early removal of the device included device migration (n=3), gastrointestinal bleeding (n=1), abdominal pain (n=2), principal investigator request (n=2), and discovery of an unrelated malignancy (n=1). Using last observation carried forward, statistically significant reductions in fasting blood glucose (-30.3±10.2 mg/dL), fasting insulin (-7.3±2.6 μU/mL), and HbA1c (-2.1±0.3%) were observed. At the end of the study, 16 of the 22 subjects had an HbA1c<7% compared with only one of 22 at baseline. Upper abdominal pain (n=11), back pain (n=5), nausea (n=7), and vomiting (n=7) were the most common device-related adverse events. CONCLUSIONS The DJBL improves glycemic status in obese subjects with diabetes and therefore represents a nonsurgical, reversible alternative to bariatric surgery.

Human hybrid NOTES transvaginal sleeve gastrectomy: initial experience

Laparoscopic sleeve gastrectomy is gaining popularity as a treatment of morbid obesity. It is a relatively new procedure with a postoperative follow-up not exceeding 5 years. The natural orifice transluminal endoscopic surgical procedures are also gaining in popularity, and we are now experiencing the first transition from animal to human trials. We describe the first sleeve gastrectomy surgery for morbid obesity using the vagina as the natural orifice in the form of a hybrid natural orifice transluminal endoscopic surgery transvaginal sleeve gastrectomy, including the short-term outcomes and complications.

Endoscopic removal of eroded adjustable gastric band: lessons learned after 5 years and 78 cases

BACKGROUND One of the complications of laparoscopic adjustable gastric banding is intragastric erosion, leading to a revisional procedure to remove the band. Our aim was to present the procedure and results of endoscopic band removal in a 5-year multicenter experience from the Gastro Obeso Center and Universidade de São Paulo, São Paulo, and Universidade Federal de Pernambuco, Recife, Brazil. METHODS From 2003 to 2008, 82 patients were diagnosed with band erosion. The clinical data concerning the endoscopic procedure were prospectively recorded and retrospectively reviewed. RESULTS The average preoperative body mass index was 43.2 kg/m(2) (range 34-50). At the diagnosis of intragastric erosion, the body mass index was 24-41 kg/m(2) (average 31.8). The erosion occurred an average of 16.3 months (range 6-36) postoperatively. The symptoms included pain in 25 (31%), port infection in 21 patients (27%), and weight regain in 20 (25%), and 12 patients (15%) were asymptomatic. Endoscopic removal was possible for 78 patients (95%). In 85% of patients, the band was removed in the first session, with an average duration of 55 minutes (range 25-150). Five cases of pneumoperitoneum occurred after the procedure. Of these, 3 were treated conservatively, 1 was treated by laparoscopy, and 1 was treated by abdominal puncture using the Veress needle. CONCLUSION Endoscopic removal of eroded laparoscopic adjustable gastric banding is safe and effective. It can be used as a first choice procedure in clinical practice.

Strictures after laparoscopic sleeve gastrectomy.

Laparoscopic sleeve gastrectomy (LSG) has become an important tool in the bariatric surgery armamentarium. At the second international consensus summit for LSG, a representative group of bariatric surgeons reported its use as a primary procedure, with excellent results and safety. The advantages that have made it so popular are the absence of dumping syndrome, no intestine is bypassed, there is no malabsorption of fundamental nutrients, mortality, and complication rates are lower, and weight loss so far is satisfactory. LSG has been considered a technically easier procedure compared with gastric bypass or biliopancreatic diversion, leading to new groups to adopt it over the latter. However, as any other procedure, LSG has complications that range from 0.7 % to 4%, some of them potentially fatal. The knowledge of their existence and their mechanisms of production is fundamental to preventing them and preserving the excellent record of safety of this technique. One of the infrequent complications of LSG is the stricture of the remnant stomach, which is constructed purposely as a narrow tube and consequently, has a risk of stenosis and obstruction. Opposite to leaks, this complication has been barely mentioned in clinical series. In addition to strictures, there are other causes of obstruction and some will be addressed in this article, which will elaborate in causes, clinical presentation, and management. It even includes technical considerations paramount to avoid mechanical obstruction of the sleeve and guarantee an adequate food intake to the patient in the long term.

Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis From the First-in-Human Proof-of-Concept Study

OBJECTIVE To assess procedural safety and glycemic indices at 6 months in a first-in-human study of duodenal mucosal resurfacing (DMR), a novel, minimally invasive, upper endoscopic procedure involving hydrothermal ablation of the duodenal mucosa, in patients with type 2 diabetes and HbA1c ≥7.5% (58 mmol/mol) on one or more oral antidiabetic agents. RESEARCH DESIGN AND METHODS Using novel balloon catheters, DMR was conducted on varying lengths of duodenum in anesthetized patients at a single medical center. RESULTS A total of 39 patients with type 2 diabetes (screening HbA1c 9.5% [80 mmol/mol]; BMI 31 kg/m2) were treated and included in the interim efficacy analysis: 28 had a long duodenal segment ablated (LS; ∼9.3 cm treated) and 11 had a short segment ablated (SS; ∼3.4 cm treated). Overall, DMR was well tolerated with minimal gastrointestinal symptoms postprocedure. Three patients experienced duodenal stenosis treated successfully by balloon dilation. HbA1c was reduced by 1.2% at 6 months in the full cohort (P < 0.001). More potent glycemic effects were observed among the LS cohort, who experienced a 2.5% reduction in mean HbA1c at 3 months postprocedure vs. 1.2% in the SS group (P < 0.05) and a 1.4% reduction at 6 months vs. 0.7% in the SS group (P = 0.3). This occurred despite net medication reductions in the LS cohort between 0 and 6 months. Among LS patients with a screening HbA1c of 7.5–10% (58–86 mmol/mol) and on stable antidiabetic medications postprocedure, HbA1c was reduced by 1.8% at 6 months (P < 0.01). CONCLUSIONS Single-procedure DMR elicits a clinically significant improvement in hyperglycemia in patients with type 2 diabetes in the short-term, with acceptable safety and tolerability. Long-term safety, efficacy, and durability and possible mechanisms of action require further investigation.

Down-to-Up transanal NOTES Total mesorectal excision for rectal cancer: Preliminary series of 9 patients

BACKGROUND: Applications for natural orifice translumenal endoscopic surgery (NOTES) to access the abdominal cavity have increased in recent years. Despite potential advantages of transanal and transcolonic NOTES for colorectal pathology, it has not been widely applied in the clinical setting. This study describes a series of nine patients for whom we performed transanal retrograde (“Down-to-Up”) total mesorectal excision for rectal cancer. MATERIALS AND METHODS: Under IRB approval, informed consent was obtained from each patient with rectal adenocarcinoma. Rectosigmoidectomy with total mesorectal excision was performed using low rectal translumenal access to the mesorectal fascia and subsequent dissection in a retrograde fashion. This was achieved using either a single port device or flexible colonoscope with endoscopic instrumentation and laparoscopic assistance. This was followed by transanal extraction of the specimen and hand-sewn anastomosis. RESULTS: Mean operative time was 311 min. Mean hospital stay was 7.56 days. Complications occurred in two patients, and consisted of one anastomotic leakage with reoperation and one intraoperative conversion to open surgery because of impossibility to dissect the specimen. TME specimen integrity was adequate in six patients. CONCLUSION: This series suggests that a retrograde mesorectal dissection via a NOTES technique is feasible in patients with rectal adenocarcinoma. This technique may act as a complimentary part of operative treatment for rectal cancer alongside other minimally invasive strategies. Long-term follow up will be needed to assess oncological results.

Achalasia and laparoscopic gastric bypass

Bariatric surgery has grown as the treatment of choice for morbid obesity, with better weight control, improvement in obesity co-morbidities and quality of life than nonoperative treatment [1]. Achalasia is a motor disease of the esophagus characterized by aperistalsis and the absence of lower esophageal sphincter relaxation. The initial stage of the achalasia course is associated with progressive dysphagia, followed by weight loss and regurgitation in the more advanced phase [2]. Surgical myotomy and endoscopic dilation are the most effective treatment options for achalasia [3]. Little information is available in published studies about the diagnosis of achalasia in the morbidly obese before bariatric surgery. We present a case of achalasia 4 years after laparoscopic Roux-en-Y gastric bypass.