Opium Effects on Pancreatobiliary System in Opium Abusers Evaluated by Endoscopic Ultrasonography.

Background: Opium use is a significant social and public health issue. There are numerous effects of opium documented as affecting the pancreatobiliary system. The aim of the study was to assess the pancreatobiliary changes in patients with opium addiction by endoscopic ultrasonography (EUS). Methods: During the study period, consecutive patients who were referred for EUS of submucosal upper gastrointestinal lesions were included. The history of opium addiction and clinical symptoms were recorded prospectively. Diameters of the common bile duct (CBD), pancreatic duct (PD), size of the ampulla of Vater, and gallbladder abnormalities were evaluated using EUS. Results: A total of 254 patients (53.1% male, mean age of 55.4±14.2 years) were studied. A history of opium addiction was present in 56 patients (22.0%). Choledocholithiasis was found in two patients (3.6%) and one control (0.5%) patient (P=0.06). Gallbladder stones were found in 13 opium-addict (23.2%) and 16 control (8.1%) patients (P=0.002). The mean diameter of the CBD, size of the ampulla of Vater (P<0.001), and PD (P=0.04) were all significantly greater in patients with opium addiction. Conclusion: Dilation of the biliary and PDs is seen more commonly in patients addicted to opium. However, the clinical implications of these findings need to be further evaluated in future studies.

Evaluation of the effect of sofosbuvir and daclatasvir in hospitalized COVID-19 patients: a randomized double-blind clinical trial (DISCOVER).

BACKGROUND: The combination of sofosbuvir and daclatasvir has shown preliminary efficacy for hospitalized patients with COVID-19 in four open-label studies with small sample sizes. This larger trial aimed to assess if the addition of sofosbuvir/daclatasvir to standard care improved clinical outcomes in hospitalized patients with COVID-19. METHODS: This was a placebo-controlled, double-blind, randomized clinical trial in adults hospitalized with COVID-19 at 19 hospitals in Iran. Patients were randomized to oral sofosbuvir/daclatasvir 400/60 mg once-daily or placebo in addition to standard of care. Patients were included if they had positive PCR or diagnostic chest CT, O2 saturation <95% and compatible symptoms. The primary outcome was hospital discharge within 10 days of randomization. Secondary outcomes included mortality and time to clinical events. The trial is registered on the Iran Registry of Clinical Trials under IRCT20200624047908N1. RESULTS: Between July and October 2020, 1083 patients were randomized to either the sofosbuvir/daclatasvir arm (n = 541) or the placebo arm (n = 542). No significant difference was observed in the primary outcome of hospital discharge within 10 days, which was achieved by 415/541 (77%) in the sofosbuvir/daclatasvir arm and 411/542 (76%) in the placebo arm [risk ratio (RR) 1.01, 95% CI 0.95-1.08, P = 0.734]. In-hospital mortality was 60/541 (11%) in the sofosbuvir/daclatasvir arm versus 55/542 (10%) in the placebo arm (RR 1.09, 95% CI 0.77-1.54, P = 0.615). No differences were observed in time to hospital discharge or time to in-hospital mortality. CONCLUSIONS: We observed no significant effect of sofosbuvir/daclatasvir versus placebo on hospital discharge or survival in hospitalized COVID-19 patients.

Colonoscopy Complications in an Iranian Teaching Hospital.

BACKGROUND: Colonoscopy is generally a safe procedure with a limited number of adverse events. Few studies have addressed the rate of adverse events in teaching hospitals. This study aimed to investigate the rate of complications after colonoscopy performed by gastroenterology fellows in a teaching hospital in Tehran. METHODS: A historical cohort study was carried out to link the colonoscopy reports and the hospital information system to identify serious adverse events leading to unplanned hospitalization, unplanned procedures or interventions (e.g. surgery), prolongation of existing hospitalization, or death within 30 days after colonoscopy. RESULTS: We included 9928 colonoscopies (mean age of the patients 53.0±15.9 years, 52.3% men) in this study. In-hospital patients comprised (34.8%) of the procedures. The indications of colonoscopy included 7137 diagnostic (71.9%), and 2519 screening (25.4%) reasons. Colorectal polyps were found in 2005 (20.2%) patients. Major complications were seen in 17 patients (0.2%), including serious bleeding in seven patients, cardiopulmonary complications in five patients, perforation in four patients, and sepsis in one patient. CONCLUSION: Serious adverse events after colonoscopy are relatively rare. The rate of complications does not appear to be higher in an academic teaching hospital when performed by fellows under supervision.

SARS-CoV-2 antibody seroprevalence in the general population and high-risk occupational groups across 18 cities in Iran: a population-based cross-sectional study.

BACKGROUND: Rapid increases in cases of COVID-19 were observed in multiple cities in Iran towards the start of the pandemic. However, the true infection rate remains unknown. We aimed to assess the seroprevalence of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 18 cities of Iran as an indicator of the infection rate. METHODS: In this population-based cross-sectional study, we randomly selected and invited study participants from the general population (from lists of people registered with the Iranian electronic health record system or health-care centres) and a high-risk population of individuals likely to have close social contact with SARS-CoV-2-infected individuals through their occupation (from employee lists provided by relevant agencies or companies, such as supermarket chains) across 18 cities in 17 Iranian provinces. Participants were asked questions on their demographic characteristics, medical history, recent COVID-19-related symptoms, and COVID-19-related exposures. Iran Food and Drug Administration-approved Pishtaz Teb SARS-CoV-2 ELISA kits were used to detect SARS-CoV-2-specific IgG and IgM antibodies in blood samples from participants. Seroprevalence was estimated on the basis of ELISA test results and adjusted for population weighting (by age, sex, and city population size) and test performance (according to our independent validation of sensitivity and specificity). FINDINGS: From 9181 individuals who were initially contacted between April 17 and June 2, 2020, 243 individuals refused to provide blood samples and 36 did not provide demographic information and were excluded from the analysis. Among the 8902 individuals included in the analysis, 5372 had occupations with a high risk of exposure to SARS-CoV-2 and 3530 were recruited from the general population. The overall population weight-adjusted and test performance-adjusted prevalence of antibody seropositivity in the general population was 17·1% (95% CI 14·6-19·5), implying that 4 265 542 (95% CI 3 659 043-4 887 078) individuals from the 18 cities included were infected by the end of April, 2020. The adjusted seroprevalence of SARS-CoV-2-specific antibodies varied greatly by city, with the highest estimates found in Rasht (72·6% [53·9-92·8]) and Qom (58·5% [37·2-83·9]). The overall population weight-adjusted and test performance-adjusted seroprevalence in the high-risk population was 20·0% (18·5-21·7) and showed little variation between the occupations included. INTERPRETATIONS: Seroprevalence is likely to be much higher than the reported prevalence of COVID-19 based on confirmed COVID-19 cases in Iran. Despite high seroprevalence in a few cities, a large proportion of the population is still uninfected. The potential shortcomings of current public health policies should therefore be identified to prevent future epidemic waves in Iran. FUNDING: Iranian Ministry of Health and Medical Education. TRANSLATION: For the Farsi translation of the abstract see Supplementary Materials section.

Sofosbuvir/daclatasvir regimens for the treatment of COVID-19: an individual patient data meta-analysis.

BACKGROUND: The combination of sofosbuvir and daclatasvir has a well-established safety profile and improves clinical outcomes in HCV patients. In silico and in vitro studies suggest that sofosbuvir/daclatasvir may show antiviral activity against SARS-CoV-2. METHODS: Three clinical trials comparing sofosbuvir/daclatasvir-based regimens with a comparator in hospitalized COVID-19 patients were combined in a meta-analysis. The primary outcomes measured were clinical recovery within 14 days of randomization, time to clinical recovery and all-cause mortality. A two-step approach was used to analyse individual-level patient data. The individual trial statistics were pooled using the random-effects inverse-variance model. RESULTS: Our search identified eight studies of which three met the inclusion criteria (n = 176 patients); two studies were randomized and one was non-randomized. Baseline characteristics were similar across treatment arms. Clinical recovery within 14 days of randomization was higher in the sofosbuvir/daclatasvir arms compared with control arms [risk ratio = 1.34 (95% CI = 1.05-1.71), P = 0.020]. Sofosbuvir/daclatasvir improves time to clinical recovery [HR = 2.04 (95% CI = 1.25-3.32), P = 0.004]. The pooled risk of all-cause mortality was significantly lower in the sofosbuvir/daclatasvir arms compared with control arms [risk ratio = 0.31 (95% CI = 0.12-0.78), P = 0.013]. CONCLUSIONS: Available evidence suggests that sofosbuvir/daclatasvir improves survival and clinical recovery in patients with moderate to severe COVID-19. However, the sample size for analysis was relatively small, one of the trials was not randomized and the designs were not standardized. These results need to be confirmed in larger randomized controlled trials.

Sofosbuvir and daclatasvir compared with standard of care in the treatment of patients admitted to hospital with moderate or severe coronavirus infection (COVID-19): a randomized controlled trial.

BACKGROUND: Currently no effective antiviral therapy has been found to treat COVID-19. The aim of this trial was to assess if the addition of sofosbuvir and daclatasvir improved clinical outcomes in patients with moderate or severe COVID-19. METHODS: This was an open-label, multicentre, randomized controlled clinical trial in adults with moderate or severe COVID-19 admitted to four university hospitals in Iran. Patients were randomized into a treatment arm receiving sofosbuvir and daclatasvir plus standard care, or a control arm receiving standard care alone. The primary endpoint was clinical recovery within 14 days of treatment. The study is registered with IRCT.ir under registration number IRCT20200128046294N2. RESULTS: Between 26 March and 26 April 2020, 66 patients were recruited and allocated to either the treatment arm (n = 33) or the control arm (n = 33). Clinical recovery within 14 days was achieved by 29/33 (88%) in the treatment arm and 22/33 (67%) in the control arm (P = 0.076). The treatment arm had a significantly shorter median duration of hospitalization [6 days (IQR 4-8)] than the control group [8 days (IQR 5-13)]; P = 0.029. Cumulative incidence of hospital discharge was significantly higher in the treatment arm versus the control (Gray's P = 0.041). Three patients died in the treatment arm and five in the control arm. No serious adverse events were reported. CONCLUSIONS: The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone. Although fewer deaths were observed in the treatment arm, this was not statistically significant. Conducting larger scale trials seems prudent.

Combination of different clinical reasoning tests in a national exam.

INTRODUCTION: Clinical reasoning as a critical and high level of clinical competency should be acquired during medical education, and medical educators should attempt to assess this ability in medical students. Nowadays, there are several ways to evaluate medical students' clinical reasoning ability in different countries worldwide. There are some well-known clinical reasoning tests such as Key Feature (KF), Clinical Reasoning Problem (CRP), Script Concordance Test (SCT), and Comprehensive Integrative Puzzle (CIP). Each of these tests has its advantages and disadvantages. In this study, we evaluated the reliability of combination of clinical reasoning tests SCT, KF, CIP, and CRP in one national exam and the correlation between the subtest scores of these tests together with the total score of the exam. METHODS: In this cross sectional study, a total number of 339 high ranked medical students from 60 medical schools in Iran participated in a national exam named "Medical Olympiad". The ninth Medical Olympiad was held in Shahid Beheshti University of Medical Sciences, Tehran, Iran, under the direct supervision of the Ministry of Health and Medical Education in summer 2017. The expert group designed a combination of four types of clinical reasoning tests to assess both analytical and non-analytical clinical reasoning. Mean scores of SCT, CRP, KF, and CIP were measured using descriptive statistics. Reliability was calculated for each test and the combination of tests using Cronbach's alpha. Spearman's correlation coefficient was used to evaluate the correlation between the score of each subtest and the total score. SPSS version 21 was used for data analysis and the level of significance was considered <0.05. RESULTS: The reliability of the combination of tests was 0.815. The reliability of KF was 0.81 and 0.76, 0.80, and 0.92 for SCT, CRP, and CIP, respectively. The mean total score was 169.921±41.54 from 240. All correlations between each clinical reasoning test and total score were significant (P<0.001). The highest correlation (0.887) was seen between CIP score and total score. CONCLUSION: The study showed that combining different clinical reasoning tests can be a reliable way of measuring this ability.

Pharmacological prophylaxis versus pancreatic duct stenting plus pharmacological prophylaxis for prevention of post-ERCP pancreatitis in high risk patients: a randomized trial.

BACKGROUND: Acute pancreatitis is a serious complication of endoscopic retrograde cholangiopancreatography (ERCP). The aim of this noninferiority study was to evaluate the effectiveness of pancreatic duct (PD) stenting plus pharmacological prophylaxis vs. pharmacological prophylaxis alone in the prevention of post-ERCP pancreatitis (PEP) in high risk patients. METHODS: In this randomized, controlled, double-blind, noninferiority trial, patients at high risk of developing PEP were randomly allocated to pharmacological prophylaxis (rectal indomethacin, sublingual isosorbide dinitrate, and intravenous hydration with Ringer's lactate) plus PD stenting (group A) or pharmacological prophylaxis alone (group B). The rate and severity of PEP, serum amylase levels, and length of hospital stay after ERCP were assessed. RESULTS: During 21 months, a total of 414 patients (mean age 55.5 ±â€Š17.0 years; 60.2 % female) were enrolled (207 in each group). PEP occurred in 59 patients (14.3 %, 95 % confidence interval [CI] 11.1 % - 17.9 %: 26 patients [12.6 %, 95 %CI 8.6 % - 17.6 %] in group A and 33 [15.9 %, 95 %CI 11.4 % - 21.4 %] in group B). There was no significant difference between the two groups in PEP severity (P = 0.59), amylase levels after 2 hours (P = 0.31) or 24 hours (P = 0.08), and length of hospital stay (P = 0.07). CONCLUSIONS: The study failed to demonstrate noninferiority or inferiority of pharmacological prophylaxis alone compared with PD stenting plus pharmacological prophylaxis in the prevention of PEP in high risk patients.

Esophageal Aperistalsis in a Patient with Lipoid Proteinosis.

Lipoid proteinosis is a rare disorder with autosomal recessive inheritance, characterized by progressive deposition of hyaline material in the skin, mucous membrane, and different organs of the body, resulting in a multitude of clinical manifestations. A 34-year-old woman presented with hoarseness, dysphagia, eyelid beeding, and acneiform scars on the facial skin and extremities. The patient was diagnosed clinically as having lipoid proteinosis, which was confirmed by laryngeal biopsy. The objective of the present report is to describe this rare entity. This case report also illustrates that lipoid proteinosis may show protean clinical features and yet may remain undiagnosed for many years.

Inappropriate Packed RBC Transfusion in a Tertiary Care Center.

INTRODUCTION: Transfusion of packed red blood cells (pRBC) with appropriate indications is not only important for patient safety and well-being but is also crucial for proper utilization of resources and health care-related cost reduction. We aimed to investigate the clinical appropriateness of blood transfusion in Shariati Hospital, one of the largest academic medical centers in Tehran. METHODS: In this prospective observational study, 1000 transfusions of allogenic pRBCs from April 1st to October 31st, 2015 were included. The patients' characteristics, reason for hospitalization, indications for pRBC transfusions and ordering wards were collected. RESULTS: The mean level of hemoglobin before transfusion was 7.4 ± 2.3 g/dL in the emergency department, 7.5 ± 1.0 g/dL in medical wards, 10.4 ± 2.6 g/dL in surgical wards, and 9.1 ± 2.2 g/dL in the intensive care unit. The baseline hemoglobin levels differed significantly between the departments (P < 0.001). Approximately 22% (219 patients) with hemoglobin level ≥ 10 g/dL received pRBC, which appeared to be unnecessary and inappropriate. CONCLUSION: Despite current international guidelines emphasizing the importance of restricted transfusion policy, the transfusion of pRBC with insufficient indications occurred frequently in Shariati Hospital, particularly in surgical wards.

Giant abdominal wall hernia in a patient with cryptogenic cirrhosis.

Abdominal wall hernias are common problems found in patients with cirrhosis because of persistently high intra-abdominal pressure. When abdominal hernias are neglected in such patients, they may become larger and could result in cosmetic problems and pressure effects that are also difficult to treat. We found a voluminous mass in the anterior abdominal wall of a 40-year-old patient with cirrhosis. The patient was operated on for acute cholecystitis 12 years earlier. Abdominal computed tomography revealed an epigastric hernia presenting as a grossly distended hernia sac filled with serous fluid and intestinal loops. The patient was not operated on and was discharged with sodium-restricted diet and diuretics.

Fulminant Hepatic Failure due to Primary Hepatic Lymphoma: a Case Report.

Primary hepatic lymphoma is a rare malignancy usually presenting withsymptoms of fever, hepatomegaly, jaundice and weight loss. This picture mimicsinfectious and inflammatory disorders and thus delays the diagnosis. Here,we present a 47-year old man with prolonged fever who underwent several investigationsand, in the meantime, developed fulminant hepatic failure beforethe diagnosis could be reached.

Diagnostic accuracy of endoscopic ultrasonography in patients with inconclusive magnetic resonance imaging diagnosis of biliopancreatic abnormalities.

AIM: To determine the sensitivity and specificity of endoscopic ultrasonography (EUS) in patients with inconclusive magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP) in pancreatobiliary abnormalities. METHODS: During 10 months, patients with pancreatobiliary diseases referred to endoscopic retrograde cholangiopancreatography (ERCP) because of inconclusive MRI/MRCP diagnosis were scheduled to undergo endoscopic ultrasonography. Patients were divided into four major groups: patients with (i) resectable periampullary neoplasms who were referred to a surgeon, (ii) unresectable periampullary cancer who underwent ERCP for biliary stenting, (iii) bile duct stone who were referred to ERCP for stone extraction, and (iv) normal pancreatobiliary tract. Reference standards for comparison were ERCP, surgery, a biopsy confirming malignancy, or the clinical course during follow up (at least 12 months) in cases without evidences of malignancy. RESULTS: One hundred and seven patients (51 men; mean [SD] age 60.0 [15.5]) were included in the study. Final diagnoses were common bile duct (CBD) stone (n = 24), periampullary neoplasms (n = 46), others (n = 23) and no pathologic findings (n = 14). EUS determined the staging for clinical decision-making in 47 patients with neoplasms which showed that tumors in 34 patients (79.1%) were unresectable (advanced stage). After EUS, 47 patients (43.9%) did not require ERCP. The accuracy of EUS for the diagnosis of CBD stone and periampullary neoplasms were 96.3% and 99.1%, respectively. CONCLUSIONS: EUS is a useful modality in cases of inconclusive MRI/MRCP indicating pancreatobiliary disorders.

Long-term follow-up of common bile duct diameter after endoscopic sphincterotomy in patients with common bile duct stones.

BACKGROUND AND AIMS: To determine the time to normalization of common bile duct (CBD) diameter after endoscopic sphincterotomy and stone extraction in patients with choledocholithiasis. METHODS: Patients with CBD dilation due to choledocholithiasis were enrolled. CBD diameter was measured by transabdominal ultrasonography before, and repeated after one, three, six and twelve months after endoscopic sphincterotomy and stone extraction, until normalization of CBD diameter. RESULTS: Of 115 cases enrolled over a 36-month period, CBD diameter reversed to normal in 71 (61.7%) patients after one month. Of the remaining 44 patients, CBD diameter reversed to normal in 36 patients (including 3 in whom repeat ERCP revealed choledocholithiasis) at the end of three months. CBD diameter had not reversed to normal diameter in 8 (18.2%) patients; none of these patients had symptoms. Two of them had asymptomatic dilated CBD after 6 months with no abnormal liver function tests (LFT); the duct reversed to normal at the last follow-up (month 12). CONCLUSIONS: Asymptomatic CBD dilation may persist in a minority of patients (18% at the end of 3 months) after removal of CBD stones. A dilated CBD can be attributed to retained choledocholithiasis within the first month, if it is associated with symptoms and abnormal LFT.

Colonoscopic evaluation of minimal rectal bleeding in average-risk patients for colorectal cancer.

AIM: To assess the prevalence of clinically significant lesions in patients with minimal bright red bleeding per rectum (BRBPR). METHODS: Consecutive outpatients prospectively underwent colonoscopy at Loghman Hakim Hospital, Tehran. Minimal BRBPR was defined as small amounts of red blood after wiping or in the toilet bowl. Patients with the following alarm signs were excluded: Positive personal history of colorectal neoplasms or inflammatory bowel disease (IBD), positive first degree family history of colorectal neoplasms, history of altered bowel habits, recent significant weight loss, and presence of iron deficiency anemia. Neoplastic polyps, colorectal carcinoma, and IBD were defined as significant lesions. RESULTS: A total of 402 patients (183 female and 219 male, aged 43.6 +/- 15.7 years) were studied. Hemorrhoids (54.2%), anal fissures (14.2%) and ulcerative colitis (14.2%) were the most common lesions and colonoscopy was normal in 8.0%. Significant lesions were found in 121 (30.1%) patients, including 26 patients (6.5%) with adenocarcinoma and 30 (7.5%) with adenomatous polyps. Almost all patients with significant lesions had at least one lesion in the distal colon; an adenocarcinoma and an adenomatous polyp in the proximal colon were found in 2 patients with hemorrhoids. CONCLUSION: Flexible sigmoidoscopy appears to be sufficient for the evaluation of average risk patients with minimal BRBPR. Rigid sigmoidoscopy may be used as an alternative in patients less than 40 years of age in settings where the former is not available. The choice of colonoscopy over flexible sigmoidoscopy in patients aged over 50 years should be individualized.

Needle-knife fistulotomy versus standard method for cannulation of common bile duct: a randomized controlled trial.

BACKGROUND: Endoscopic retrograde cholangiopancreatography with endoscopic sphincterotomy has become widely available for the treatment of pancreatobiliary diseases; however, it has mortality and complications. The aim of this study was to compare the success rates and complications of two different methods of common bile duct cannulation. METHODS: From June 2003 though February 2004, patients who were candidates for endoscopic retrograde cholangiopancreatography and/or endoscopic sphincterotomy were randomly divided into two groups: standard cannulation (group A) and suprapapillary needle-knife fistulotomy (group B). Postendoscopic retrograde cholangiopancreatography pancreatitis, cholangitis, bleeding, and perforation were evaluated. RESULTS: Two hundred and eighteen cases (86 males and 132 females with a mean+/-SD age of 56.2+/-17.5 years) were enrolled in this study. Group A, contained 112 patients and group B included 106 patients. In group A, the final cannulation success was achieved in 100 patients (89.3%). Cannulation was successful in 88 patients (83.0%) in group B. Difficulty in cannulation occurred more frequently in group A (25.5% vs. 2.6%, P=0.002). There were two patients in group B and three patients in group A who developed pancreatitis after endoscopic retrograde cholangiopancreatography. Perforation occurred in one patient in group B, which was improved with medical support. Bleeding and cholangitis were not occurred in any of the groups. The overall complication rate was 3/112 in group A and 3/106 in group B. CONCLUSION: Needle-knife fistulotomy is safe and can be applied as an effective alternative to standard technique for common bile duct cannulation in expert hands.