Eduardo Guimarães Hourneaux de Moura

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.

Treatment of malignant gastroduodenal obstruction with a nitinol self-expanding metal stent: an international prospective multicentre registry.

BACKGROUND Duodenal stenting has become a broadly accepted first line of treatment for patients with advanced malignant gastroduodenal obstruction as these patients are difficult to treat and are poor surgical candidates. AIMS To document duodenal stent performance for palliative management of malignant gastroduodenal obstruction. METHODS Multicentre, single arm, prospective registry documenting peroral endoscopic duodenal stenting procedures in 202 patients. RESULTS Technical success achieved in 98% (CI, 95%, 99%) of stent placements. Increase of Gastric Outlet Obstruction Score by at least 1 point compared to baseline was achieved in 91% (CI, 86%, 95%) of patients persisting for a median of 184 days (CI, 109, 266). By day 5 (CI, 4, 6) after stent placement, 50% of patients experienced a score increase of at least 1 point. Improvement from 14% of patients at baseline tolerating soft solids or low residue/normal diet to 84% at 15 days, 86% at 30 days, 81% at 90 days, 79% at 180 days, and 70% at 270 days. Complications included stent ingrowth and/or overgrowth (12.4%), transient periprocedural symptoms (3%), bleeding (3%), stent migration (1.5%), and perforation (0.5%). CONCLUSIONS Safety and effectiveness of duodenal stenting for palliation of malignant gastroduodenal obstruction was confirmed in the largest international prospective series to date.

EUS-guided choledochoantrostomy: an alternative for biliary drainage in unresectable pancreatic cancer with duodenal invasion

Endoscopic transpapillary biliary drainage is the criterion standard procedure for biliary decompression. However, ERCP can fail in 3% to 10% of cases. 1-4 In these cases, percutaneous transhepatic biliary drainage and surgical intervention are the alternatives. 1,3,4 These alternatives have significant morbidity. 5-8 However, a more recent option is EUS-guided biliary drainage (EUS-BD). We describe a case of unresectable pancreatic cancer with biliary obstruction and extensive duodenal invasion that was successfully treated with a variation of the EUS-BD by performing a choledochoantrostomy.

EUS-Guided Choledochoduodenostomy for Biliary Drainage in Unresectable Pancreatic Cancer: A Case Series

CONTEXT Endoscopic retrograde cholangiopancreatography (ERCP) is the procedure of choice for biliary decompression in patients with unresectable pancreatic cancer. However, it may be unsuccessful in 3 to 10% of cases. When ERCP is unsuccessful, the usual alternatives are percutaneous transhepatic biliary drainage or surgery. Recently, several authors have reported the use of EUS-guided biliary drainage in patients with malignant biliary obstructions, with acceptable success and complication rates. We describe three cases of unresectable pancreatic cancer associated with obstructive jaundice, treated by EUS-guided biliary drainage. CASE REPORT Three patients with unresectable pancreatic cancer, associated with obstructive jaundice, were included. ERCP was unsuccessful because of complete tumor obstruction of the distal common bile duct and papilla invasion. An EUS-guided rendezvous maneuver was attempted, without success. Then, EUS-guided choledochoduodenostomy, with a partially covered self-expanding metal stent, was performed in the same procedure. There were no early complications and the procedure was also clinically effective in relieving jaundice in all cases. CONCLUSIONS EUS-guided biliary drainage is a feasible alternative to percutaneous transhepatic biliary drainage or surgery in unresectable pancreatic cancer with obstructive jaundice when ERCP fails. However, the development of new specific instruments and studies comparing this procedure with percutaneous transhepatic biliary drainage and surgery are needed.

Deep sedation during gastrointestinal endoscopy: Propofol-fentanyl and midazolam-fentanyl regimens

AIM To compare deep sedation with propofol-fentanyl and midazolam-fentanyl regimens during upper gastrointestinal endoscopy. METHODS After obtaining approval of the research ethics committee and informed consent, 200 patients were evaluated and referred for upper gastrointestinal endoscopy. Patients were randomized to receive propofol-fentanyl or midazolam-fentanyl (n = 100/group). We assessed the level of sedation using the observers assessment of alertness/sedation (OAA/S) score and bispectral index (BIS). We evaluated patient and physician satisfaction, as well as the recovery time and complication rates. The statistical analysis was performed using SPSS statistical software and included the Mann-Whitney test, χ² test, measurement of analysis of variance, and the κ statistic. RESULTS The times to induction of sedation, recovery, and discharge were shorter in the propofol-fentanyl group than the midazolam-fentanyl group. According to the OAA/S score, deep sedation events occurred in 25% of the propofol-fentanyl group and 11% of the midazolam-fentanyl group (P = 0.014). Additionally, deep sedation events occurred in 19% of the propofol-fentanyl group and 7% of the midazolam-fentanyl group according to the BIS scale (P = 0.039). There was good concordance between the OAA/S score and BIS for both groups (κ = 0.71 and κ = 0.63, respectively). Oxygen supplementation was required in 42% of the propofol-fentanyl group and 26% of the midazolam-fentanyl group (P = 0.025). The mean time to recovery was 28.82 and 44.13 min in the propofol-fentanyl and midazolam-fentanyl groups, respectively (P < 0.001). There were no severe complications in either group. Although patients were equally satisfied with both drug combinations, physicians were more satisfied with the propofol-fentanyl combination. CONCLUSION Deep sedation occurred with propofol-fentanyl and midazolam-fentanyl, but was more frequent in the former. Recovery was faster in the propofol-fentanyl group.

Endoscopic submucosal dissection for the treatment of early esophageal and gastric cancer - initial experience of a western center

BACKGROUND Endoscopic submucosal dissection is a new Japanese technique characterized by en-bloc resection of the entire lesion irrespective of size, with lower local recurrence when compared to endoscopic mucosal resection. OBJECTIVE To evaluate the feasibility, early results and complications of the endoscopic submucosal dissection technique for treating early gastric and esophageal cancer at the Endoscopic Unit of Clinics Hospital and Cancer Institute of the São Paulo University. MATERIALS AND METHODS Twenty patients underwent endoscopic resection using the endoscopic submucosal dissection technique for early gastric or esophageal cancer. The patients were evaluated prospectively as to the executability of the technique, the short-term results of the procedure and complications. RESULTS Sixteen gastric adenocarcinoma lesions and six esophageal squamous carcinoma lesions were resected. In the stomach, the mean diameter of the lesions was 16.2 mm (0.6–3.5 mm). Eight lesions were type IIa + IIc, four were type IIa and four IIc, with thirteen being well differentiated and three undifferentiated. Regarding the degree of invasion, five were M2, seven were M3, two were Sm1 and one was Sm2. The mean duration of the procedures was 85 min (20–160 min). In the esophagus, all of the lesions were type IIb, with a mean diameter of 17.8 mm (6–30 mm). Regarding the degree of invasion, three were M1, one was M2, one was M3 and one was Sm1. All had free lateral and deep margins. The mean time of the procedure was 78 min (20–150 min) CONCLUSION The endoscopic submucosal dissection technique was feasible in our service with a high success rate.

Effectiveness of intragastric balloon for obesity: A systematic review and meta-analysis based on randomized control trials ☆

BACKGROUND Obesity has become a worldwide epidemic, and many methods are currently used to reduce obesity. This systematic review shows the effectiveness of the intragastric balloon (IGB) method compared to the sham/diet (s/d) method. OBJECTIVE To demonstrate the effectiveness of the IGB method compared to the s/d method. SETTING Hospital das Clinicas da Universidade de São Paulo, Brazil, Public Hospital. METHODS After searching MEDLINE, Embase, Cochrane, Lilacs, Scopus, and CINAHL, only enrolled randomized control trials comparing IGB/diet with s/d were analyzed. For qualitative analysis, 12 studies were selected, and 9 of these were acceptable for quantitative analysis. RESULTS The IGB/diet is more effective than s/d when comparing body mass index (BMI) loss with a mean difference of 1.1 kg/m(2) by the Students t test and 1.41 kg/m(2) by the meta-analysis, with significant differences in both. It is also more effective in weight loss (WL), with a mean difference of 2 kg by the Students t test and 3.55 kg by the meta-analysis. In the qualitative analysis of % excess WL (%EWL), the mean %EWL is 14.0% in favor of the IGB group compared to the s/d group by the Students t test; however, no significant difference was found between these groups by quantitative analysis. CONCLUSION Based on randomized control trial data alone, IGB>400 mL is more effective than sham/diet in achieving BMI loss, WL, and %EWL.

Duodenal stenting for malignant gastric outlet obstruction: Prospective study

AIM To evaluate the results of duodenal stenting for palliation of gastroduodenal malignant obstruction by using a gastric outlet obstruction score (GOOS). METHODS A prospective, non-randomized study was performed at a tertiary center between August 2005 and April 2010. Patients were eligible if they had malignant gastric outlet obstruction (GOO) and were not candidates for surgical treatment. Medical history and patient demographics were collected at baseline. Scheduled interviews were made on the day of the procedure and 15, 30, 90 and 180 d later or unscheduled as necessary. RESULTS Fifteen patients (6 male, 9 female; median age 61 years) with GOO who had undergone duodenal stenting were evaluated. Ten patients had metastasis at baseline (66.6%) and 14 were unable to accept oral intake (93.33%), including 7 patients who were using a feeding tube. Laboratory data showed biliary obstruction in eight cases (53.33%); all were submitted to biliary drainage. Two patients developed obstructive symptoms due to tumor ingrowth after 30 d and another due to tumor overgrowth after 180 d. Two cases of stent migration occurred. A good response to treatment was observed, with a mean time of approximately 1 d (19 h) until toleration of a liquid diet and slightly more than 2 d for both soft solids (51 h) and a solid food/normal diet (55 h). The mean time to first failure to maintain liquid intake (GOOS ≥ 1) was 93 d. During follow-up, the mean time to first failure to maintain the previously achieved GOOS of 2-3 (solid/semi-solid food), considered technical failure, was 71 d. On the basis of oral intake a GOOS is defined: 0 for no oral intake; 1 for liquids only; 2 for soft solids only; 3 for low-residue or full diet. CONCLUSION Enteral stenting to alleviate gastroduodenal malignant obstruction improves quality of life in patients with limited life expectancy, which can be evaluated by using a GOO scoring system.

INITIAL EXPERIENCE OF ENDOSCOPIC SUBMUCOSAL DISSECTION IN BRAZIL TO TREAT EARLY GASTRIC AND ESOPHAGHEAL CANCER: a multi-institutional analysis

OBJECTIVE This study aimed to evaluate the feasibility and clinicopathological characteristics of early gastric and esophageal cancers treated with endoscopic submucosal dissection (ESD) at five centers in Brazil. METHODS Five centers in Brazil reported their initial experience with ESD. The cases reported had already been collected by each center before pooled analysis. RESULTS Were resected 62 gastric lesions; 52(83,8%) of the gastric lesions were well-differentiated adenocarcinoma, 31(50%) from the antrum, 24 (38.7%) type IIa. 51 (82.2%) lesions had en-block resection with three showing lateral margin compromise. Concerning invasion, 25 (40.3%) tumors were M1. Mean tumor diameter was 18.9 mm (range, 0.6-5.0 cm) and mean procedure duration was 119.45 minutes. Gastric perforation occurred in three (4.8%) patients. Mean follow-up duration was 11.3 months, with two local recurrences and one death from pneumonia Seven months after treatment. Of the 16 esophageal lesions resected, 14 (87.4%) were squamous cell carcinoma, 10 (62.5%) were located proximally and 8 (50.0%) type IIa. Mean tumor diameter was 23.8 mm (range, 6-60 mm). Thirteen (81.2%) lesions had en-block resection with five cases of lateral margin compromise. Eight (50.0%) lesions were M1. Mean procedure duration was 78 minutes (range, 20-150 min). Complications included pneumomediastinum in two (12.5%) patients and stenosis in one (6.2%). Mean duration of follow-up was 8.6 months, with no local recurrence despite the presence of lateral margin compromise. CONCLUSION Different centers in Brazil feasibly perform ESD with a high success rate.

Endoscopic stenting for inoperable malignant biliary obstruction: A systematic review and meta-analysis

AIM To analyze through meta-analyses the benefits of two types of stents in the inoperable malignant biliary obstruction. METHODS A systematic review of randomized clinical trials (RCT) was conducted, with the last update on March 2015, using EMBASE, CINAHL (EBSCO), MEDLINE, LILACS/CENTRAL (BVS), SCOPUS, CAPES (Brazil), and gray literature. Information of the selected studies was extracted in sight of six outcomes: primarily regarding dysfunction, complication and re-intervention rates; and secondarily costs, survival, and patency time. The data about characteristics of trial participants, inclusion and exclusion criteria and types of stents were also extracted. The bias was mainly assessed through the JADAD scale. This meta-analysis was registered in the PROSPERO database by the number CRD42014015078. The analysis of the absolute risk of the outcomes was performed using the software RevMan, by computing risk differences (RD) of dichotomous variables and mean differences (MD) of continuous variables. Data on RD and MD for each primary outcome were calculated using the Mantel-Haenszel test and inconsistency was qualified and reported in χ (2) and the Higgins method (I (2)). Sensitivity analysis was performed when heterogeneity was higher than 50%, a subsequent assay was done and other findings were compiled. Students t-test was used for the comparison of weighted arithmetic means regarding secondary outcomes. RESULTS Initial searching identified 3660 studies; 3539 were excluded through title, repetition, and/or abstract, while 121 studies were fully assessed and were excluded mainly because they did not compare self-expanding metal stents (SEMS) and plastic stents (PS), leading to thirteen RCT selected, with 13 articles and 1133 subjects meta-analyzed. The mean age was 69.5 years old, that were affected mostly by bile duct (proximal) and pancreatic tumors (distal). The preferred SEMS diameter used was the 10 mm (30 Fr) and the preferred PS diameter used was 10 Fr. In the meta-analysis, SEMS had lower overall stent dysfunction compared to PS (21.6% vs 46.8%, P < 0.00001) and fewer re-interventions (21.6% vs 56.6%, P < 0.00001), with no difference in complications (13.7% vs 15.9%, P = 0.16). In the secondary analysis, the mean survival rate was higher in the SEMS group (182 d vs 150 d, P < 0.0001), with a higher patency period (250 d vs 124 d, P < 0.0001) and a lower cost per patient (4193.98 vs 4728.65 Euros, P < 0.0985). CONCLUSION SEMS are associated with lower stent dysfunction, lower re-intervention rates, better survival, and higher patency time. Complications and costs showed no difference.