Correction: Intraductal radiofrequency ablation plus biliary stent versus stent alone for malignant biliary obstruction: a systematic review and meta-analysis.

[This corrects the article DOI: 10.1055/a-2204-8316.].

Intraductal radiofrequency ablation plus biliary stent versus stent alone for malignant biliary obstruction: a systematic review and meta-analysis.

Background and study aims Recurrent biliary stent occlusion and tumor ingrowth remain a major concern among patients with malignant biliary obstruction (MBO) with significant impact on patient morbidity and survival. Intraductal radiofrequency ablation (RFA) has emerged as a promising treatment that seeks to extend stent patency. This study aimed to evaluate the impact of RFA on overall survival (OS) and stent patency among patients with unresectable MBO. Methods A comprehensive search of electronic databases was performed for randomized controlled trials (RCTs) comparing RFA plus biliary stent (RFA+S) versus biliary stent alone (S-alone). Outcomes assessed included overall survival, stent patency, and adverse events (AEs) with mean difference (MD) calculated from pooled proportions. Subgroup analyses were performed for hilar strictures and cholangiocarcinoma (CCA). Results Six RCTs (n=439 patients) were included and demonstrated improved survival among patients who received RFA+S (MD 85.80 days; 95% confidence interval [CI] 35.02-136.58; I 2 =97%; P <0.0009). The pooled MD for total stent patency was 22.25 days (95% CI 17.38-61.87; I 2 =97%; P =0.27). There was no difference in AEs between RFA+S vs S-alone ( P >0.05). On subgroup analyses, RFA+S was associated with improved stent patency (MD 76.73 days; 95% CI 50.11-103.34; I 2 =67%; P <0.01) and OS (MD 83.14 (95% CI 29.52-136.77; I 2 =97%; P <0.01] for CCA. For hilar strictures, stent patency was improved among patients with RFA+S [MD 83.71 days (95% CI 24.85-142.56; I 2 =84%; P <0.01]. Conclusions RFA+S improved OS in the treatment of MBO when compared with S-alone. Moreover, the RFA therapy prolonged stent patency in hilar strictures and CCA, with similar rates of AEs.

Biliary drainage in inoperable malignant biliary distal obstruction: A systematic review and meta-analysis.

BACKGROUND: Endoscopic drainage remains the treatment of choice for unresectable or inoperable malignant distal biliary obstruction (MDBO). AIM: To compare the safety and efficacy of plastic stent (PS) vs self-expanding metal stent (SEMS) placement for treatment of MDBO. METHODS: This meta-analysis was developed according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. A comprehensive search was performed in MEDLINE, Cochrane, Embase, Latin American and Caribbean Health Sciences Literature, and grey literature to identify randomized clinical trials (RCTs) comparing clinical success, adverse events, stent dysfunction rate, reintervention rate, duration of stent patency, and mean survival. Risk difference (RD) and mean difference (MD) were calculated and heterogeneity was assessed with I 2 statistic. Subgroup analyses were performed by SEMS type. RESULTS: Twelve RCTs were included in this study, totaling 1005 patients. There was no difference in clinical success (RD = -0.03, 95% confidence interval [CI]: -0.01, 0.07; I 2 = 0%), rate of adverse events (RD = -0.03, 95%CI: -0.10, 0.03; I 2 = 57%), and mean patient survival (MD = -0.63, 95%CI: -18.07, 19.33; I 2 = 54%) between SEMS vs PS placement. However, SEMS placement was associated with a lower rate of reintervention (RD = -0.34, 95%CI: -0.46, -0.22; I 2 = 57%) and longer duration of stent patency (MD = 125.77 d, 95%CI: 77.5, 174.01). Subgroup analyses revealed both covered and uncovered SEMS improved stent patency compared to PS (RD = 152.25, 95%CI: 37.42, 267.07; I 2 = 98% and RD = 101.5, 95%CI: 38.91, 164.09; I 2 = 98%; respectively). Stent dysfunction was higher in the covered SEMS group (RD = -0.21, 95%CI: -0.32, -0.1; I² = 205%), with no difference in the uncovered SEMS group (RD = -0.08, 95%CI: -0.56, 0.39; I² = 87%). CONCLUSION: While both stent types possessed a similar clinical success rate, complication rate, and patient-associated mean survival for treatment of MDBO, SEMS were associated with a longer duration of stent patency compared to PS.

Adverse Events and Complications with Intragastric Balloons: a Narrative Review (with Video).

Intragastric balloon (IGB) is a minimally invasive and reversible therapy for weight loss with a good efficacy and safety profile. Introduced in the 1980s, IGBs have significantly evolved in the last couple of decades. They mechanically act by decreasing the volume of the stomach and its reservoir capacity, delaying gastric emptying, and increasing satiety leading to a subsequent weight loss. Despite the low rates of complications and mortality associated with IGBs, adverse events and complications still occur and can range from mild to fatal. This review aims to provide an update on the current scientific evidence in regard to complications and adverse effects of the use of the IGB and its treatment. This is the first comprehensive narrative review in the literature dedicated to this subject.

Approach to Endoscopic Procedures: A Routine Protocol from a Quaternary University Referral Center Exclusively for Coronavirus Disease 2019 Patients.

OBJECTIVES: The present coronavirus disease (COVID-19) pandemic has ushered in an unprecedented era of quality control that has necessitated advanced safety precautions and the need to ensure the adequate protection of healthcare professionals (HCPs). Endoscopy units, endoscopists, and other HCP may be at a significant risk for transmission of the virus. Given the immense burden on the healthcare system and surge in the number of patients with COVID-19, well-designed protocols and recommendations are needed. We aimed to systematically characterize our approach to endoscopic procedures in a quaternary university hospital setting and provide summary protocol recommendations. METHOD: This descriptive study details a COVID-19-specific protocol designed to minimize infection risks to patients and healthcare workers in the endoscopy unit. RESULTS: Our institution, located in São Paulo, Brazil, includes a 900-bed hospital, with a 200-bed-specific intensive care unit exclusively designed for patients with moderate and severe COVID-19. We highlighted recommendations for infection prevention and control during endoscopic procedures, including appropriate triage and screening, outpatient management and procedural recommendations, role and usage of personal protective equipment (PPE), and role and procedural logistics involving COVID-19-positive patients. We also detailed hospital protocols for reprocessing endoscopes and cleaning rooms and also provided recommendations to minimize severe acute respiratory syndrome coronavirus 2 transmission. CONCLUSION: This COVID-19-specific administrative and clinical protocol can be replicated or adapted in multiple institutions and endoscopy units worldwide. Furthermore, the recommendations and summary protocol may improve patient and HCP safety in these trying times.

Efficacy of digital single-operator cholangioscopy in the visual interpretation of indeterminate biliary strictures: a systematic review and meta-analysis.

OBJECTIVE: Indeterminate biliary strictures remain a significant diagnostic challenge. Digital single-operator cholangioscopy (D-SOC) incorporates digital imaging which enables higher resolution for better visualization and diagnosis of biliary pathology. We aimed to conduct a systematic review and meta-analysis of available literature in an attempt to determine the efficacy of D-SOC in the visual interpretation of indeterminate biliary strictures. MATERIAL AND METHODS: Electronic searches were performed using Medline (PubMed), EMBASE, and Cochrane Library. All D-SOC studies that reported the diagnostic performance in visual interpretation of indeterminate biliary strictures and biliary malignancies were included. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 was used to evaluate the quality of the included studies. All data were extracted and pooled to construct a 2 × 2 table. The visual interpretation of D-SOC was compared to resected surgical specimens or clinical follow-up in the included patients. Pooled sensitivity, specificity, positive predictive value, negative predictive value, prevalence, positive likelihood ratio (+LR), negative likelihood ratio (-LR), and diagnostic odds ratio (OR) were calculated. The summarized receiver operating characteristic (SROC) curve corresponding with the area under the curve (AUC) was also analyzed. RESULTS: The search yielded 465 citations. Of these, only six studies with a total of 283 procedures met inclusion criteria and were included in the meta-analysis. The overall pooled sensitivity and specificity of D-SOC in the visual interpretation of biliary malignancies was 94% (95% CI 89-97) and 95% (95%CI 90-98), respectively, while +LR, -LR, diagnostic OR, and AUC were 15.20 (95%CI 5.21-44.33), 0.08 (95%CI 0.04-0.14), 308.83 (95%CI 106.46-872.82), and 0.983, respectively. The heterogeneity among 6 included studies was moderate for specificity (I2 = 0.51) and low for sensitivity (I2 = 0.17) and diagnostic OR (I2 = 0.00). CONCLUSION: D-SOC is associated with high sensitivity and specificity in the visual interpretation of indeterminate biliary strictures and malignancies. D-SOC should be considered routinely in the diagnostic workup of indeterminate biliary lesions.

Adverse events after biliary sphincterotomy: Does the electric current mode make a difference? A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Biliary sphincterotomy is an invasive method that allows access to the bile ducts, however, this procedure is not exempt of complications. Studies in the literature indicate that the mode of electric current used for sphincterotomy may carry different incidences of adverse events such as pancreatitis, hemorrhage, perforation, and cholangitis. AIM: To evaluate the safety of different modes of electrical current during biliary sphincterotomy based on incidence of adverse events. METHODS: We searched articles for this systematic review in Medline, EMBASE, Central Cochrane, Lilacs, and gray literature from inception to September 2019. Data from studies describing different types of electric current were meta-analyzed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The following electric current modalities were evaluated: endocut, blend, pure cut, pure cut followed by blend, monopolar, and bipolar. RESULTS: A total of 1791 patients from 11 randomized clinical trials evaluating the following comparisons: 1. Endocut vs Blend: No statistical difference in the incidence of bleeding (7% vs 13.4%; RD: -0.11 [-0.31, 0.08], P=0.27, I2=86%), pancreatitis (4.4% vs 3.5%; RD: 0.01 [-0.03, 0.04], P=0.62, I2=48%) and perforation (absence of cases in both arms). 2. Endocut vs Pure cut: Higher incidence of mild bleeding (without drop in hemoglobin levels, clinical repercussion or need for endoscopic intervention) in the pure cut group (9.2% vs 28.8%; RD: -0.19 [-0.27, -0.12], P<0.00001, I2=0%). No statistical difference regarding pancreatitis (5.2% vs 0.9%; RD: 0.05 [-0.01, 0.11], P=0.12, I2=57%), perforation (0.4% vs 0%; RD: 0.00 [-0.01, 0.02], P=0.7, I2=0%) or cholangitis (1.8% vs 3.2%; RD: -0.01 [-0.09, 0.06], P=0,7). 3. Pure cut vs blend: higher incidence of mild bleeding in the pure cut group (40.4% vs 16.7%; RD: 0.24 [0.15, 0.33], P<0.00001, I2=0%). No statistical difference concerning incidence of pancreatitis or cholangitis. 4. Pure cut vs Pure cut followed by Blend: No statistical difference regarding incidence of bleeding (22.5% vs 11.7%; RD: -0.10 [-0.24, 0.04], P=0.18, I2=61%) and pancreatitis (8.9% vs 14.8%; RD 0.06 [-0.02, 0.13], P=0.12, I2=0%). 5. Blend vs pure cut followed by blend: no statistical difference regarding incidence of bleeding and pancreatitis (11.3% vs 10.4%; RD -0.01 [-0.11, 0.09], P=0.82, I2=0%). 6. Monopolar vs bipolar: higher incidence of pancreatitis in the monopolar mode group (12% vs 0%; RD 0.12 [0.02, 0.22], P=0.01). CONCLUSION: Pure cut carries higher incidences of mild bleeding compared to endocut and blend. However, this modality might present a lower incidence of pancreatitis. The monopolar mode elicits higher rates of pancreatitis in comparison with the bipolar mode. There is no difference in incidence of cholangitis or perforation between different types of electric current. There is a lack of evidence in the literature to recommend one method over the others, therefore new studies are warranted. As there is no perfect electric current mode, the choice in clinical practice must be based on the patient risk factors.

Approach to endoscopic procedures: a routine protocol from a quaternary university referral center exclusively for coronavirus disease 2019 patients

OBJECTIVES: The present coronavirus disease (COVID-19) pandemic has ushered in an unprecedented era of quality control that has necessitated advanced safety precautions and the need to ensure the adequate protection of healthcare professionals (HCPs). Endoscopy units, endoscopists, and other HCP may be at a significant risk for transmission of the virus. Given the immense burden on the healthcare system and surge in the number of patients with COVID-19, well-designed protocols and recommendations are needed. We aimed to systematically characterize our approach to endoscopic procedures in a quaternary university hospital setting and provide summary protocol recommendations. METHOD: This descriptive study details a COVID-19-specific protocol designed to minimize infection risks to patients and healthcare workers in the endoscopy unit. RESULTS: Our institution, located in São Paulo, Brazil, includes a 900-bed hospital, with a 200-bed-specific intensive care unit exclusively designed for patients with moderate and severe COVID-19. We highlighted recommendations for infection prevention and control during endoscopic procedures, including appropriate triage and screening, outpatient management and procedural recommendations, role and usage of personal protective equipment (PPE), and role and procedural logistics involving COVID-19-positive patients. We also detailed hospital protocols for reprocessing endoscopes and cleaning rooms and also provided recommendations to minimize severe acute respiratory syndrome coronavirus 2 transmission. CONCLUSION: This COVID-19-specific administrative and clinical protocol can be replicated or adapted in multiple institutions and endoscopy units worldwide. Furthermore, the recommendations and summary protocol may improve patient and HCP safety in these trying times.

Advances in Therapeutic Cholangioscopy.

Nowadays, cholangioscopy is an established modality in diagnostic and treatment of pancreaticobiliary diseases. The more widespread use and the recent development of new technologies and accessories had renewed the interest of endoscopic visualization of the biliary tract, increasing the range of indications and therapeutic procedures, such as diagnostic of indeterminate biliary strictures, lithotripsy of difficult bile duct stones, ablative techniques for intraductal malignancies, removal of foreign bodies and gallbladder drainage. These endoscopic interventions will probably be the last frontier in the near future. This paper presents the new advances in therapeutic cholangioscopy, focusing on the current clinical applications and on research areas.