Clinical Validation of an Office-Based 14C-UBT (Heliprobe) for H. pylori Diagnosis in Iranian Dyspeptic Patients

Background. We encountered repeatedly, in our clinical practice, discordant results between UBT and histopathology about H. pylori infection. Goal. To study the diagnostic accuracy of Heliprobe 14C-urea breath test (14C-UBT) for detection of H. pylori infection in an Iranian population. Study. We enrolled 125 dyspeptic patients in our study. All of them underwent gastroscopy, and four gastric biopsies (three from the antrum and one from the corpus) were obtained. One of the antral biopsies was utilized for a rapid urease test (RUT), and three others were evaluated under microscopic examination. Sera from all patients were investigated for the presence of H. pylori IgG antibodies. The 14C-UBT was performed on all subjects using Heliprobe kit, and results were analyzed against the following gold standard (GS): H. pylori infection considered positive when any two of three diagnostic methods (histopathology, RUT, serology) are positive. Results. According to data analysis, the Heliprobe 14C-UBT had 94% sensitivity, 100% specificity, 93% negative predictive value (NPV), 100% positive predictive value (PPV), and 97% accuracy, compared with GS. Conclusion. The Heliprobe 14C-UBT is an easy-to-perform, rapid-response, and accurate test for H. pylori diagnosis, suitable for office use

An international experience with single-operator cholangiopancreatoscopy in patients with altered anatomy

Background and study aims: The utility of digital single- operator cholangiopancreatoscopy (D-SOCP) in surgically altered anatomy (SAA) is limited. We aimed to evaluate the technical success and safety of D-SOCP in patients SAA. Patients and methods: Patients with SAA who underwent D-SOCP between February 2015 and June 2020 were retrospectively evaluated. Technical success was defined as completing the intended procedure with the use of D-SOCP. Results: Thirty-five patients underwent D-SOCP (34 D-SOC, 1 D-SOP). Bilroth II was the most common type of SAA (45.7 %), followed by Whipple reconstruction (31.4 %). Twenty-three patients (65.7 %) patients had prior failed ERCP due to the presence of complex biliary stone (52.2 %). A therapeutic duodenoscope was utilized in the majority of the cases (68.6 %), while a therapeutic gastroscope (22.7 %) or adult colonoscope (8.5 %) were used in the remaining procedures. Choledocholithiasis (61.2 %) and pancreatic duct calculi (3.2 %) were the most common indications for D-SOCP. Technical success was achieved in all 35 patients (100 %) and majority (91.4 %) requiring a single session. Complex interventions included electrohydraulic or laser lithotripsy, biliary or pancreatic stent placement, stricture dilation, and target tissue biopsies. Two mild adverse events occurred (pancreatitis and transient bacteremia). Conclusions: In SAA, D-SOCP is a safe and effective modality to diagnose and treat complex pancreatobiliary disorders, especially in cases where standard ERCP attempts may fail

Gastric per-oral endoscopic myotomy (G-POEM) for refractory gastroparesis: results from an international prospective trial

OBJECTIVE: Although gastric per-oral endoscopic myotomy (G-POEM) is considered a promising technique for the management of refractory gastroparesis, high-quality evidence is limited. We prospectively investigated the efficacy and safety of G-POEM in unselected patients with refractory gastroparesis. DESIGN: In five tertiary centres, patients with symptomatic gastroparesis refractory to standard medical therapy and confirmed by impaired gastric emptying were included. The primary endpoint was clinical success, defined as at least one score decrease in Gastroparesis Cardinal Symptom Index (GCSI) with ≥25% decrease in two subscales, at 12 months. GCSI Score and subscales, adverse events (AEs) and 36-Item Short Form questionnaire of quality of life were evaluated at baseline and 1, 3, 6 and 12 months after G-POEM. Gastric emptying study was performed before and 3 months after the procedure. RESULTS: Of 80 enrolled patients, 75 patients (94%) completed 12-month follow-up. Clinical success at 12 months was 56% (95% CI, 44.8 to 66.7). GCSI Score (including subscales) improved moderately after G-POEM (p\u3c0.05). In a regression model, a baseline GCSI Score \u3e2.6 (OR=3.23, p=0.04) and baseline gastric retention \u3e20% at 4 hours (OR=3.65, p=0.03) were independent predictors of clinical success at 12 months, as was early response to G-POEM at 1 month after therapy (OR 8.75, p\u3c0.001). Mild procedure-related AEs occurred in 5 (6%) patients. CONCLUSION: G-POEM is a safe procedure, but showed only modest overall effectiveness in the treatment of refractory gastroparesis. Further studies are required to identify the best candidates for G-POEM; unselective use of this procedure should be discouraged. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry NCT02732821

A Comparative Analysis of Clinical Characteristics and Laboratory Findings of COVID-19 between Intensive Care Unit and Non-Intensive Care Unit Pediatric Patients: A Multicenter, Retrospective, Observational Study from Iranian Network for Research in Viral

Introduction: To date, little is known about the clinical features of pediatric COVID-19 patients admitted to intensive care units (ICUs). Objective: Herein, we aimed to describe the differences in demographic characteristics, laboratory findings, clinical presentations, and outcomes of Iranian pediatric COVID-19 patients admitted to ICU versus those in non-ICU settings. Methods: This multicenter investigation involved 15 general and pediatrics hospitals and included cases with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection based on positive real-time reverse transcription polymerase chain reaction (RT-PCR) admitted to these centers between March and May 2020, during the initial peak of the COVID-19 pandemic in Iran. Results: Overall, 166 patients were included, 61 (36.7%) of whom required ICU admission. The highest number of admitted cases to ICU were in the age group of 1–5 years old. Malignancy and heart diseases were the most frequent underlying conditions. Dyspnea was the major symptom for ICU-admitted patients. There were significant decreases in PH, HCO3 and base excess, as well as increases in creatinine, creatine phosphokinase (CPK), lactate dehydrogenase (LDH), and potassium levels between ICU-admitted and non-ICU patients. Acute respiratory distress syndrome (ARDS), shock, and acute cardiac injury were the most common features among ICU-admitted patients. The mortality rate in the ICU-admitted patients was substantially higher than non-ICU cases (45.9% vs. 1.9%, respectively; p<0.001). Conclusions: Underlying diseases were the major risk factors for the increased ICU admissions and mortality rates in pediatric COVID-19 patients. There were few paraclinical parameters that could differentiate between pediatrics in terms of prognosis and serious outcomes of COVID-19. Healthcare providers should consider children as a high-risk group, especially those with underlying medical conditions

Effects of Blended (Yellow) vs Forced Coagulation (Blue) Currents on Adverse Events, Complete Resection, or Polyp Recurrence After Polypectomy in a Large Randomized Trial

Background & aims: There is debate over the type of electrosurgical setting that should be used for polyp resection. Some endoscopists use a type of blended current (yellow), whereas others prefer coagulation (blue). We performed a single-blinded, randomized trial to determine whether type of electrosurgical setting affects risk of adverse events or recurrence. Methods: Patients undergoing endoscopic mucosal resection of nonpedunculated colorectal polyps 20 mm or larger (n = 928) were randomly assigned, in a 2 × 2 design, to groups that received clip closure or no clip closure of the resection defect (primary intervention) and then to either a blended current (Endocut Q) or coagulation current (forced coagulation) (Erbe Inc) (secondary intervention and focus of the study). The study was performed at multiple centers, from April 2013 through October 2017. Patients were evaluated 30 days after the procedure (n = 919), and 675 patients underwent a surveillance colonoscopy at a median of 6 months after the procedure. The primary outcome was any severe adverse event in a per patient analysis. Secondary outcomes were complete resection and recurrence at first surveillance colonoscopy in a per polyp analysis. Results: Serious adverse events occurred in 7.2% of patients in the Endocut group and 7.9% of patients in the forced coagulation group, with no significant differences in the occurrence of types of events. There were no significant differences between groups in proportions of polyps that were completely removed (96% in the Endocut group vs 95% in the forced coagulation group) or the proportion of polyps found to have recurred at surveillance colonoscopy (17% and 17%, respectively). Procedural characteristics were comparable, except that 17% of patients in the Endocut group had immediate bleeding that required an intervention, compared with 11% in the forced coagulation group (P = .006). Conclusions: In a randomized trial to compare 2 commonly used electrosurgical settings for the resection of large colorectal polyps (Endocut vs forced coagulation), we found no difference in risk of serious adverse events, complete resection rate, or polyp recurrence. Electrosurgical settings can therefore be selected based on endoscopist expertise and preference

Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial

Background & aims: Bleeding is the most common severe complication after endoscopic mucosal resection of large colon polyps and is associated with significant morbidity and cost. We examined whether prophylactic closure of the mucosal defect with hemoclips after polyp resection reduces the risk of bleeding. Methods: We performed a multicenter, randomized trial of patients with a large nonpedunculated colon polyp (≥20 mm) at 18 medical centers in North America and Spain from April 2013 through October 2017. Patients were randomly assigned to groups that underwent endoscopic closure with a clip (clip group) or no closure (control group) and followed. The primary outcome, postprocedure bleeding, was defined as a severe bleeding event that required hospitalization, a blood transfusion, colonoscopy, surgery, or another invasive intervention within 30 days after completion of the colonoscopy. Subgroup analyses included postprocedure bleeding with polyp location, polyp size, or use of periprocedural antithrombotic medications. We also examined the risk of any serious adverse event. Results: A total of 919 patients were randomly assigned to groups and completed follow-up. Postprocedure bleeding occurred in 3.5% of patients in the clip group and 7.1% in the control group (absolute risk difference [ARD] 3.6%; 95% confidence interval [CI] 0.7%-6.5%). Among 615 patients (66.9%) with a proximal large polyp, the risk of bleeding in the clip group was 3.3% and in the control group was 9.6% (ARD 6.3%; 95% CI 2.5%-10.1%); among patients with a distal large polyp, the risks were 4.0% in the clip group and 1.4% in the control group (ARD -2.6%; 95% CI -6.3% to -1.1%). The effect of clip closure was independent of antithrombotic medications or polyp size. Serious adverse events occurred in 4.8% of patients in the clip group and 9.5% of patients in the control group (ARD 4.6%; 95% CI 1.3%-8.0%). Conclusions: In a randomized trial, we found that endoscopic clip closure of the mucosal defect following resection of large colon polyps reduces risk of postprocedure bleeding. The protective effect appeared to be restricted to large polyps located in the proximal colon

Clinical Study Clinical Validation of an Office-Based 14 C-UBT (Heliprobe) for H. pylori Diagnosis in Iranian Dyspeptic Patients

Background. We encountered repeatedly, in our clinical practice, discordant results between UBT and histopathology about H. pylori infection. Goal. To study the diagnostic accuracy of Heliprobe 14 C-urea breath test ( 14 C-UBT) for detection of H. pylori infection in an Iranian population. Study. We enrolled 125 dyspeptic patients in our study. All of them underwent gastroscopy, and four gastric biopsies (three from the antrum and one from the corpus) were obtained. One of the antral biopsies was utilized for a rapid urease test (RUT), and three others were evaluated under microscopic examination. Sera from all patients were investigated for the presence of H. pylori IgG antibodies. The 14 C-UBT was performed on all subjects using Heliprobe kit, and results were analyzed against the following gold standard (GS): H. pylori infection considered positive when any two of three diagnostic methods (histopathology, RUT, serology) are positive. Results. According to data analysis, the Heliprobe 14 C-UBT had 94% sensitivity, 100% specificity, 93% negative predictive value (NPV), 100% positive predictive value (PPV), and 97% accuracy, compared with GS. Conclusion. The Heliprobe 14 C-UBT is an easy-to-perform, rapid-response, and accurate test for H. pylori diagnosis, suitable for office use

The Prevalence, Risk Factors, and Clinical Correlates of Erosive Esophagitis and Barrett’s Esophagus in Iranian Patients with Reflux Symptoms

Background. Erosive esophagitis (EE) and Barrett’s esophagus (BE) are the two important complications of gastroesophageal reflux disease. We aimed to investigate the prevalence of and the risk factors for EE and BE in an Iranian group of patients with reflux symptoms. We also examined the relationship between reflux symptoms and endoscopic findings. Methods. A total of 736 patients with gastroesophageal reflux disease (GERD) symptoms were enrolled and all underwent upper gastrointestinal endoscopy. Diagnosis of Barrett’s esophagus was confirmed by pathologic examination and Helicobacter pylori (H. pylori) infection was demonstrated by rapid urease test. Results. Two hundred eighty-three and 34 patients were found to have EE and BE, respectively. Multivariate analysis showed that hiatal hernia (P<0.001) and H. pylori infection (P<0.002) were the two significantly related risk factors for esophagitis. Only age was related to BE, with BE patients being more likely to be older (P<0.001) than others. Conclusions. Prevalence of EE and BE in Iranian reflux patients is similar to that seen in western countries. H. pylori infection and the presence of hiatal hernia may be strong risk factors for esophagitis as does older age for Barrett’s esophagus. Finally, reflux symptoms have no significant relationship with endoscopic findings