Marcos Eduardo Lera dos Santos

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.

Complex biliary stones management: cholangioscopy versus papillary large balloon dilation - a randomized controlled trial

Background and study aims  Endoscopic removal of biliary stones has high success rates, ranging between 85 % to 95 %. Nevertheless, some stones may be challenging and different endoscopic methods have evolved. Papillary large balloon dilation after sphincterotomy is a widely used technique with success rates ranging from 68 to 90 % for stones larger than 15 mm. Cholangioscopy allows performing lithotripsy under direct biliary visualization, either by laser or electrohydraulic waves, which have similar success rate (80 % – 90 %). However, there is no study comparing these 2 techniques. Patients and methods  From April 2014 to June 2016, 100 patients were enrolled and randomized in 2 groups, using a non-inferiority hypothesis: cholangioscopy + electrohydraulic lithotripsy (group 1) and endoscopic papillary large balloon dilation (group 2). The main outcome was complete stone removal. Adverse events were documented. Mechanical lithotripsy was not performed. Failure cases had a second session with crossover of the methods. Results  The mean age was 56 years. 74 (75.5 %) patients were female. The initial overall complete stone removal rate was 74.5 % (77.1 % in group 1 and 72 % in group 2, P  > 0.05). After second session the overall success rate achieved 90.1 %. Procedure time was significantly lower in group 2, – 25.2 min (CI95 % – 12.48 to – 37.91). There were no significant differences regarding technical success rate, radiologic exposure and adverse events. Conclusion  Single-operator cholangioscopy-guided lithotripsy and papillary large balloon dilation are effective and safe approaches for removing complex biliary stones.

Endoscopic treatment of large pancreatic fluid collections (PFC) using self-expanding metallic stents (SEMS) – a two-center experience

Background/study aim: During the last several years, endoscopic ultrasound (EUS)-guided pancreatic fluid collections’ (PFC) drainage has evolved into the preferred drainage technique. Recently, self-expanding metallic stents (SEMS) have been used as an alternative to double pigtail stents, with the advantage of providing a larger diameter fistula, thereby decreasing the risk of early obstruction and also allowing for direct endoscopic exploration of the cavity. The aim of this study was to evaluate the technical and clinical success, safety, and outcome of patients undergoing EUS-guided drainage of complex PFC using SEMS. Patients/materials and methods: The study was conducted at two tertiary hospitals from January 2010 to January 2013. All patients with PFC referred for endoscopic drainage were enrolled in a prospective database. The inclusion criteria were: (1) patients with pseudocysts or walled-off necrosis based on the revised Atlanta classification; (2) symptomatic patients with thick PFC; (3) PFC that persisted more than 6 weeks; and (4) large PFC diameter (≥ 9 cm). The exclusion criteria consisted of coagulation disorders, PFC bleeding or infection, and failure-to-inform written consent. Results: A total of 16 patients (9 females, 7 males; mean age 52.6, range 20 – 82) underwent EUS drainage with SEMS. There were 14 cases of pseudocysts and 2 cases of walled-off necrosis. The etiologies of the PFC were mainly gallstones (8 of 16 patients, 50 %) and alcohol (5 of 16 patients, 31 %). Technical success was achieved in 100 % of the cases. All patients had a complete resolution of the PFC. Conclusion: Transmural EUS-guided drainage of complex PFC using SEMS is feasible, appears safe, and is efficacious. However, the exchange of the UC (uncovered)-SEMS for plastic stents is mandatory within 1 week. Future prospective studies, preferably multicenter studies, comparing SEMS versus traditional plastic stents for the drainage of PFC are warranted.

Comparison between endoscopic sphincterotomy vs endoscopic sphincterotomy associated with balloon dilation for removal of bile duct stones: A systematic review and meta-analysis based on randomized controlled trials

AIM To compare gallstones removal rate and incidence of bleeding, pancreatitis, use of mechanical lithotripsy, cholangitis and perforation between isolated sphincterotomy vs sphincterotomy associated with balloon dilation of papilla in choledocholithiasis through the meta-analysis of randomized clinical trials. METHODS We conducted a systematic review according to the PRISMA guidelines. Literature search was restricted to randomized controlled trials (RCTs) on MedLine, Cochrane Library, LILACS, and EMBASE database platforms in July 2017. The manual search included references of retrieved articles. We extracted data focusing on outcomes: The primary endpoint was the stones removal rate; Secondary endpoints were rates of pancreatitis, bleeding, use of mechanical lithotripsy (ML), perforation and cholangitis. RESULTS Eleven RCTs with 1824 patients were included. EST was associated with more post-endoscopic retrograde cholangiopancreatography (ERCP) bleeding [FE RD-0.02, CI (-0.03, -0.00), I2 = 33%, P = 0.05] and more need of mechanical lithotripsy in general [RE RD-0.16, CI (-0.25, -0.06), I2 = 90%, P = 0.002] and in subgroup analysis of stones greater than 15 mm [RE RD-0.20, CI (-0.38, -0.02), I2 = 82%, P = 0.003]. Incidence of pancreatitis [FE RD-0.01, CI (-0.03, 0.01), I2 = 0, P = 0.36], cholangitis [FE RD-0.00, CI (-0.01, 0.01), I2 =0, P = 0.97] and perforation [FE RD-0.01, CI (-0.01, 0.00), I2 = 0, P = 0.23] was similar between the groups as well as similar stone removal rates in general [FE RD-0.01, CI (-0.01, 0.04), I2 = 0, P = 0.23] and pooled analysis of stones greater than 15 mm [FE RD-0.02, CI (-0.02, 0.07), I2 = 11%, P = 0.31]. CONCLUSION Through meta-analysis of randomized clinical trials we found that isolated sphincterotomy was associated with more post-ERCP bleeding and more need for mechanical lithotripsy. However, there was no statistical difference in the stone removal rate between isolated sphincterotomy and sphincterotomy associated with balloon dilation in the approach to remove gallstones.

Metallic vs plastic stents to treat biliary stricture after liver transplantation: a systematic review and meta-analysis based on randomized trials

Background and study aims  The first-line approach to anastomotic biliary stricture after orthotopic liver transplantation (OLTX) involves endoscopic retrograde cholangiopancreatography (ERCP). The most widely used technique is placement of multiple plastic stents, but discussions are ongoing on the benefits of fully-covered self-expandable metallic stents (FCEMS) in this situation. This study aimed to compare results from use of plastic and metal stents to treat biliary stricture after transplantation. Patients and methods  Searches were performed in the Medline, EMBASE, SciELO/LILACS, and Cochrane databases, and only randomized studies comparing the two techniques were included in the meta-analysis. Results  Our study included four randomized clinical trials totaling 205 patients. No difference was observed between the stricture resolution rate (RD: 0.01; 95 %CI [−0.08 – 0.10]), stricture recurrence (RD: 0.13; 95 %CI [−0.03 – 0.28]), and adverse events (RD: −0.10; 95 %CI [−0.65 – 0.44]) between the plastic and metallic stent groups. The metallic stent group demonstrated benefits in relation to the number of ERCPs performed (MD: −1.86; 95 %CI [−3.12 to −0.6]), duration of treatment (MD: −105.07; 95 %CI [−202.38 to −7.76 days]), number of stents used (MD: −10.633; 95 %CI [−20.82 to −0.44]), and cost (average

EUS-FNA versus ERCP for tissue diagnosis of suspect malignant biliary strictures: a prospective comparative study

 8,288.50 versus

A comparison of the efficiency of 22G versus 25G needles in EUS-FNA for solid pancreatic mass assessment: A systematic review and meta-analysis

 18,580.00, P  < 0.001). Conclusions  Rates of resolution and recurrence of stricture are similar, whereas the number of ERCPs performed, number of stents used, duration of treatment, and costs were lower in patients treated with FCEMS, which shows that this device is a valid option for initial treatment of post-OLTX biliary stricture.

II Brazilian consensus statement on endoscopic ultrasonography

Background and study aims  Biliary strictures are frequently a challenging clinical scenario and the anatomopathological diagnosis is essential in the therapeutic management, whether for curative or palliative purposes. The acquisition of specimens is necessary since many benign diseases mimic biliopancreatic neoplasms. Endscopic retrograde cholangiopancreatography (ERCP) is the traditionally used method despite the low sensitivity of biliary brush cytology and forceps biopsy. On the other hand, several studies reported good accuracy rates using endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). The aim of this prospective study was to compare, the accuracy of EUS-FNA and ERCP for tissue sampling of biliary strictures. Patients and methods  After performing the sample size calculation, 50 consecutive patients with indeterminate biliary strictures were included to undergo ERCP and EUS on the same sedation.The gold-standard was surgery or 6 months’ follow-up. Evaluation of the diagnostic indices (sensitivity, specificity, positive and negative predictive value, positive and negative likelihood ratio), concordance and adverse events among the methods were performed. Also, subtype analyses of the techniques, anatomical localization and size of the lesion were included. Results  The final diagnoses reported in 50 patients were 47 malignant, 1 suspicious and 2 benign lesions. 31 lesions were extraductal and 19 intraductal, 35 were distal and 15 proximal strictures. In the intention-to-treat analysis, the sensitivity and accuracy of EUS-FNA were superior than ERCP tissue sampling (93,8 %, 94 % vs. 60,4 %, 62 %, respectively) ( P  = 0.034), with similar adverse events. There was no concordance between the methods and combining both methods improved the sensitivity and accuracy for 97.9 % and 98 %, respectively. In the subtype analyses, the EUS-FNA was superior, with a higher accuracy than ERCP tissue sampling in evaluating extraductal lesions (100 % vs. 54.8 %, P  = 0.019) and in those larger than 1.5 cm (95.8 % vs. 61.9 %, P  = 0.031), but were similar in evaluating intraductal lesions and lesions smaller than 1.5 cm. There was no significant difference between the methods in the analyzes of proximal, distal and pancreatic lesions. Conclusion  EUS-FNA is better than ERCP with brush cytology and intraductal forceps biopsy in diagnosing malignant biliary strictures, mainly in the assessment of extraductal lesions and in those larger than 1.5 cm. Combining ERCP with tissue sampling and EUS-FNA is feasible, the techniques have similar complication rates, and the combination greatly improves diagnostic accuracy.

Role of EUS evaluation after endoscopic eradication of esophageal varices with band ligation

Our aim in this study was to compare the efficiency of 25G versus 22G needles in diagnosing solid pancreatic lesions by EUS-FNA. We performed a systematic review and meta-analysis. Studies were identified in five databases using an extensive search strategy. Only randomized trials comparing 22G and 25G needles were included. The results were analyzed by fixed and random effects. A total of 504 studies were found in the search, among which 4 randomized studies were selected for inclusion in the analysis. A total of 462 patients were evaluated (233: 25G needle/229: 22G needle). The diagnostic sensitivity was 93% for the 25G needle and 91% for the 22G needle. The specificity of the 25G needle was 87%, and that of the 22G needle was 83%. The positive likelihood ratio was 4.57 for the 25G needle and 4.26 for the 22G needle. The area under the sROC curve for the 25G needle was 0.9705, and it was 0.9795 for the 22G needle, with no statistically significant difference between them (p=0.497). Based on randomized studies, this meta-analysis did not demonstrate a significant difference between the 22G and 25G needles used during EUS-FNA in the diagnosis of solid pancreatic lesions.