Paulo Sakai

Guidewire Cannulation Reduces Risk of Post-ERCP Pancreatitis and Facilitates Bile Duct Cannulation

OBJECTIVE:To evaluate if using a soft-tipped guidewire to cannulate the common bile duct may ameliorate development of post-ERCP pancreatitis and facilitate cannulation of the CBD.DESIGN AND SETTING:A single-center, blinded, randomized trial of conventional cannulation technique using sphinctertome and contrast injection versus guidewire cannulation technique.METHODS:We prospectively randomized 300 patients to conventional cannulation (group I) or guidewire cannulation (group II) technique.OUTCOME MEASURES:Primary outcome measure was incidence of acute pancreatitis and secondary outcome measures were ease of cannulation of common bile duct (assessed by attempts required for common bile duct cannulation & rates of precut sphincterotomy) and overall complication rates.RESULTS:Guidewire cannulation was associated with significantly lower likelihood of post-ERCP pancreatitis (adjusted OR 0.43, 95% CI 0.21–0.89, P = 0.02). Twenty-five patients (16.6%) in group I and thirteen patients (8.6%) in group II developed acute pancreatitis, P = 0.037. All instances of pancreatitis were mild. There were more women in group II; 41 in group I and 59 in group II, P = 0.028. Otherwise the two groups were comparable for age, age under 35 yr, indication for ERCP, diagnosis, and number of patients with SOD. The number of patients requiring 0–3, 4–6, and 7–10 attempts for successful cannulation of the common bile duct were 87, 48, and 15 in group I and 117, 24, and 9 in group II, respectively, P = 0.001. A total of 33 patients in group I and 13 patients in group II required precut sphincterotomy, P = 0.007. Rates of accidental pancreatic duct cannulation were 21 in group I and 27 in group II, P = 0.34. Rates of overall complication were not significantly different in the two groups.CONCLUSIONS:Guidewire technique for bile duct cannulation lowers likelihood of post-ERCP pancreatitis by facilitating cannulation and reducing need for precut sphincterotomy.

Surgery or Endoscopy for Palliation of Biliary Obstruction Due to Metastatic Pancreatic Cancer

BACKGROUND AND AIMS:Both endoscopic and surgical drainage procedures are effective palliative methods for malignant biliary obstruction. Surgical drainage is still preferred in developing countries due to the high cost of procuring metal biliary stents. The aim of this study was to evaluate the quality of life and the cost of care in patients with metastatic pancreatic cancer after endoscopic biliary drainage and surgical drainage.PATIENTS AND METHODS:This is a prospective, randomized controlled trial conducted in a tertiary referral center in Brazil. Patients with biliary obstruction due to metastatic pancreatic cancer and liver metastasis, but without gastric outlet obstruction, were included in the study. Endoscopic biliary drainage with the insertion of a metal stent into the bile duct was compared with the surgical drainage procedure (choledochojejunostomy and gastrojejunostomy). Quality of life was assessed before, and 30 days, 60 days, and 120 days after the drainage procedure. The cost of drainage procedure, cost during the first 30 days and the total cost from drainage procedure to death were calculated.RESULTS:Of the 273 patients with pancreatic malignancy seen at our hospital between July 2001 and October 2004, 35 patients were eligible for the study, and 30 agreed to participate in the study. Both surgical and endoscopic drainage procedures were successful, without any mortality in the first 30 days. The cost of biliary drainage procedure (US

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

2,832 ± 519 vs 3,821 ± 1,181, p = 0.031), the cost of care during the first 30 days after drainage (US

Endoscopic sphincterotomy before deployment of covered metal stent is associated with greater complication rate: a prospective randomized control trial.

3,122 ± 877 vs 6,591 ± 711, p = 0.001), and the overall total cost of care that included initial care and subsequent interventions and hospitalizations until death (US

Kras mutation analysis of fine needle aspirate under EUS guidance facilitates risk stratification of patients with pancreatic mass

4,271 ± 2,411 vs 8,321 ± 1,821, p = 0.0013) were lower in the endoscopy group compared with the surgical group. In addition, the quality of life scores were better in the endoscopy group at 30 days (p = 0.042) and 60 days (p = 0.05). There was no difference between the two groups in complication rate, readmissions for complications, and duration of survival.CONCLUSIONS:Endoscopic biliary drainage is cheaper and provides better quality of life in patients with biliary obstruction and metastatic pancreatic cancer.

Echoguided hepatico-gastrostomy: a case report

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.

Role of proximal gut exclusion from food on glucose homeostasis in patients with Type 2 diabetes.

Objective Endoscopic sphincterotomy (ES) may facilitate insertion of self expandable metal stent (SEMS) and also help avert the development of pancreatitis from stent-related occlusion of the pancreatic duct. On the other hand, ES is also independently associated with pancreatitis, bleeding, and perforation. We evaluated whether ES before SEMS placement was associated with a greater likelihood of stent migration and other complications in patients with malignant obstruction of the distal common bile duct. Methods Seventy-four patients with unresectable distal bile duct obstruction were prospectively randomized to biliary stenting following ES (group 1) and without ES (group 2). Main outcome measures included overall procedure complications rates including stent migration, stent occlusion, oxygen desaturation, bleeding, perforation, and pancreatitis. Results Covered SEMS were successfully deployed in all patients in both groups. Stent migration occurred in 6 patients (16%) in group 1 and 1 patient (3%) in group 2, P=0.075. Overall, complications occurred in 18 patients in group 1 and 4 patients in group 2, P=0.006. There was no pancreatitis in either group. Conclusions Deployment of covered SEMS without prior ES in patients with distal common bile duct obstruction owing to pancreatic cancer is feasible and prevents the development of complications such as stent migration, bleeding, and perforation.

A pilot study to evaluate the safety, tolerance, and efficacy of a novel stationary antral balloon (SAB) for obesity.

Objectives The accuracy of endoscopic ultrasound-fine needle aspiration cytology (EUS-FNAC) for the diagnosis of pancreatic cancer is suboptimal. Mutational activation of the kras oncogene is almost universally present in pancreatic cancer tissue. We, therefore, investigated if analysis for mutant kras gene in the EUS-FNAC aspirates supplements cytopathology for the diagnosis of pancreatic adenocarcinoma (PAC). Methods EUS-FNAC specimens obtained from 74 patients with pancreatic masses were analyzed for the presence of kras mutation on codon 12 using polymerase chain reaction-restriction fragment length polymorphism and MvaI restriction enzyme. Definitive diagnosis was based on surgical pathology or long-term follow-up (median 27.8 mo); 57 patients had PAC, 11 patients chronic pancreatitis, and 9 patients nonfunctioning neuroendocrine tumors. Results Analysis of mutant kras gene in addition to cytopathology allowed the detection of PAC in 4 additional patients as compared with cytopathology alone. Cytopathology and kras mutant analysis were negative for PAC in 17 patients of whom 6 patients (35%) had PAC. The respective sensitivity (90.9% vs. 82.5%), specificity (47.6% vs. 97.9%), positive predictive value (89.5% vs. 83.8%), negative predictive value (98.1% vs. 94.1%), accuracy (89.2% vs. 58.8%) of cytopathology plus kras mutation versus cytopathology were numerically superior but did not reach statistical significance. Conclusions Analysis for the presence of mutant kras gene supplements conventional cytopathology for the diagnosis of PAC even without a cytopathologist in attendance and using only 3 needle passes. Among patients with negative cytopathology, the presence of kras mutation represents pancreatic cancer while the absence of kras mutation increases the possibility of benign lesion.

Radial Endoscopic Ultrasound and Spiral Computed Tomography in the Diagnosis and Staging of Periampullary Tumors

and maybe seen as a variation of the intrahepatic approach, butwithout selective drainage through the ampulla.In terms of a minimally invasive concept and low com-plication rate, this is the first presentation of hepatico-gas-trostomy drainage using both endoscopic ultrasound andfluoroscopy guidance performed at the Gastrointestinal En-doscopy Unit in the Hospital das Clinicas – University ofSao Paulo School of Medicine.

ERCP Using Double-Balloon Enteroscopy in Patients with Roux-en-Y Anatomy

To report Type 2 diabetes‐related outcomes after the implantation of a duodenal‐jejunal bypass liner device and to investigate the role of proximal gut exclusion from food in glucose homeostasis using the model of this device.