The efficacy of Elbasvir/Grazoprevir fixed-dose combination for 8 weeks in HCV treatment and health-related quality of life (HRQoL) in treatment-naïve, non-cirrhotic, genotype 4-infected patients (ELEGANT-4): A single-center, single-arm, open-label, phase 3 trial.

Background: Cost, adverse events, and long treatment duration can be significant obstacles in treating hepatitis C virus (HCV)-infected individuals. Shortening the treatment regimen can minimize these barriers, thereby enhancing adherence and increasing medication availability to more patients. Methods: This is a single-centre, single-arm, open-label, phase 3 clinical trial on treatment naïve, non-cirrhotic, HCV genotype 4 patients. The study aimed to evaluate an 8-week course of Elbasvir (ELB)/Grazoprevir (GZR) in this population. The primary endpoint was sustained virologic response at 12 weeks after the end of treatment (SVR-12). The secondary endpoints were SVR-4, adverse events, and changes in health- and hepatitis-related quality of life (HRQoL). Results: Of the 30 patients who were enrolled, 29 (97%) achieved SVR-12 and SVR-4 (95% CI: 90-100%). No patients experienced serious or life-threatening adverse events (AEs), but mild/moderate AEs were reported by 16 (53%). The most commonly reported AEs were itching/skin rash (20%), headache (16.7%), abdominal/epigastric pain and decreased appetite (13.3% each), and nausea/vomiting (10%). Marked improvements in HRQoL were reported between the first (baseline) and third (SVR-12) timepoints. HRQoL score improvements involved the physical, mental, and hepatitis-specific indices, and ranged between 6 and 42 points (out of 100, P ≤0.003). Conclusion: The trial provides empirical evidence that HCV genotype 4-infected patients can achieve viral eradication with an 8-week-regimen of ELB/GZR. Further, this course of treatment is associated with a minimal adverse event profile and potentially significant improvements in quality of life. (ClinicalTrials.gov number, NCT03578640).

Peroral endoscopic myotomy (POEM) for the treatment of achalasia: A multicenter Middle Eastern experience.

BACKGROUND: Peroral endoscopic myotomy (POEM) was proposed in 2010 as a minimally invasive procedure for the treatment of achalasia. In this article, we describe the Middle Eastern experience with the procedure in terms of efficacy, length of admission, and short- and long-term complications. METHODS: A retrospective analysis of our prospectively collected data on patients who underwent a POEM procedure was conducted between March 2019 and May 2020. The primary outcome was clinical success rate, defined as a postprocedure Eckardt score ≤3 at ≥3 months. Secondary outcomes included the length of hospital stay, presence of reflux symptoms or need for proton pump inhibitors (PPIs) ≥3 months, and adverse events. RESULTS: During the study period, 67 patients (35 females) underwent the procedure for achalasia. The participants' ages ranged from 11 to 80 years (mean 41 ± 18 years). Eckardt scores before the treatment ranged between 4 and 12 (mean 8.85 ± 1.75). Sixty-four patients (95.5%) achieved Eckardt scores of ≤3 at ≥3 months after the procedure (95% confidence interval [CI]: 91%-100%). The difference between pre- and post-procedural Eckardt scores averaged around -8 points (95% CI: -7.5 to -8.5 P < 0.0001). Adverse events were reported in 24 patients (35.8%) and included pneumoperitoneum (32.8%), reflux symptoms at 3 months (29.9%), and surgical emphysema (3%). Six patients had adverse events that led to prolongation of admission; 3% of whom had aspiration pneumonia, 3% had pneumoperitoneum, 1.5% had both, and 1.5% had an esophageal tear. CONCLUSIONS: POEM is a promising procedure for the treatment of achalasia with a high clinical success rate, short hospital admission, and a reassuring safety profile.

Peripancreatic fluid collections, plastic stents, and different sub-types of metal stents: Where does the evidence land?

BACKGROUND: Peripancreatic fluid collections (PFCs) are a frequent complication of acute pancreatitis. Symptomatic PFCs may need to be drained, and there are multiple endoscopic accessories that can facilitate the procedure. This paper aims to compare the success rate, number of procedures required for resolution and adverse events rate for PFCs EUS-guided drainage with plastic stents and lumen-apposing metal stents (LAMS). METHODS: This is a retrospective analysis of a consecutive sample of patients that was collected from 2013 - 2019. The medical records of these patients were reviewed, and the outcomes for each type of stent (plastic vs LAMS, and different subtypes of LAMS) were compared in terms of clinical success, number of re-interventions needed, and adverse events. RESULTS: A total of 33 patients (23 males) were treated for PFCs with EUS-guided drainage and stenting. The patients' ages ranged between 14 and 85 years (mean ± SD: 43.5 ± 19 years). Overall, there was no difference between plastic stents and LAMS in terms of symptomatic recovery (P = 0. 24), but metal stents had better results with regards to radiological resolution (P = 0.03), and were associated with a higher number of necrosectomies (P = 0.029). Adverse events occurred more frequently in patients who had plastic stents, but direct comparison between the two groups showed that the difference was not statistically significant (P = 0.2). Stratification for different LAMS subtypes showed no difference in terms of symptomatic or radiological resolution (P =0.49), number of rescue procedures (P = 0.41), and adverse events (P = 0.81). CONCLUSION: Our study, along with the current available evidence, suggests a slight advantage of metal stents over plastic stents in terms of clinical success, need for rescue procedures, and incidence of adverse events. Furthermore, it provides empirical evidence that the different sub-types of LAMS perform similarly when compared against each other.

Factors underlying surrogate medical decision-making in middle eastern and east Asian women: a Q-methodology study.

BACKGROUND: It is not clear how lay people prioritize the various, sometimes conflicting, interests when they make surrogate medical decisions, especially in non-Western cultures. The extent such decisions are perspective-related is also not well documented. METHODS: We explored the relative importance of 28 surrogate decision-making factors to 120 Middle-Eastern (ME) and 120 East-Asian (EA) women from three perspectives, norm-perception (N), preference as patient (P), and preference as surrogate decision-maker (S). Each respondent force-ranked (one to nine) 28 opinion-items according to each perspective. Items' ranks were analyzed by averaging-analysis and Q-methodology. RESULTS: Respondents' mean (SD) age was 33.2 (7.9) years; all ME were Muslims, 83% of EA were Christians. "Trying everything possible to save patient," "Improving patient health," "Patient pain and suffering," and/or "What is in the best interests of patient" were the three most-important items, whereas "Effect of caring for patient on all patients in society," "Effect of caring for patient on patients with same disease," and/or "Cost to society from caring for patient" were among the three least-important items, in each ME and EA perspectives. P-perspective assigned higher mean ranks to family and surrogate's needs and burdens-related items, and lower mean rank to "Fear of loss" than S-perspective (p<0.001). ME assigned higher mean ranks to "Medical facts" and "Surrogate own wishes for patient" and lower mean rank to "Family needs" in all perspectives (p<0.001). Q-methodology identified models that were relatively patient's preference-, patient's religious/spiritual beliefs-, or emotion-dependent (all perspectives); medical facts-dependent (N- and S-perspectives), financial needs-dependent (P- and S-perspectives), and family needs-dependent (P-perspective). CONCLUSIONS: 1) Patient's health was more important than patient's preference to ME and EA women; society interest was least important. 2) Family and surrogate's needs/ burdens were more important, whereas fear of loss was less important to respondents as patients than as surrogate decision-makers. 3) Family needs were more important to EA than ME respondents, the opposite was true for medical facts and surrogate's wishes for patient. 4) Q-methodology models that relatively emphasized various surrogate decision-making factors overlapped the ME and EA women' three perspectives.

Removal of proximally migrated biliary stents by using single-operator cholangioscopy.

BACKGROUND AND AIMS: Migration is a late adverse event of biliary stent placement. It occurs in 1% to 20% of cases and is associated with a diverse array of adverse events. In this article, we report our take on endoscopic extraction of proximally migrated biliary stents by the use of single-operator cholangioscopy. METHODS: This report includes 3 patients who were found to have proximal stent migration while being treated for biliary stones. One patient had a migrated metal stent, and the other 2 had plastic stents. Single-operator cholangioscopy was used to retrieve the stents in all patients. The SpyBite biopsy forceps accessory was used to extract the metal stent, whereas the SpyBasket and the SpySnare were used to extract the plastic stents. RESULTS: All patients underwent successful stent removal by the techniques described in this report, with no immediate adverse events, and they completed more than 4 weeks of follow-up care with no further adverse events. CONCLUSIONS: Digital single-operator cholangioscopy with SpyBasket, retrieval snare, and SpyBite biopsy forceps can be useful tools to remove migrated plastic and metallic stents, respectively.

The utility of digital cholangioscopy (SpyGlass DS) in biliary and pancreatic diseases: A clinical feasibility study at two tertiary care centers in Saudi Arabia (with Videos).

BACKGROUND AND STUDY AIM: Since its inception in 2007, single-operator cholangioscopy (SOC) has gained popularity for many diagnostically and therapeutically challenging biliary and pancreatic conditions. Many studies have been published to evaluate the feasibility, usefulness, cost-effectiveness, and safety profile of the first generation. This paper is a descriptive study in which we aim to share the experience of two tertiary care centers with the novel version of SOC, SpyGlass DS. PATIENTS AND METHODS: We retrospectively reviewed the records of all the patients who went through the procedure from October 2015 - July 2019 to explore the scope of biliary and pancreatic conditions in which SOC was utilized. Technical success was defined as the ability to visualize the lesion and complete the procedure as planned, whereas clinical success was determined by the ability to achieve the desired diagnostic/therapeutic outcome. RESULTS: During the period of interest, 66 patients (34 males) went through 84 cholangioscopy procedures. Forty-four patients failed the conventional extraction methods and needed the intervention for the treatment of difficult stones, 24 patients needed a diagnostic evaluation of biliary strictures, and 3 needed an intervention to remove migrated stents. Technical success was achieved in 98.8% (83/84) of the procedures (95% CI: 96-100%). Regarding clinical success, stone breakdown and removal was achieved in 92% of the procedures (49/53; 95% CI: 85-100%). Tissue samples were successfully obtained in 95.8% (23/24) of patients with strictures (95% CI: 88-100%). The biopsy was appropriate to make a histological diagnosis in 83.3% of cases (20/24; 95% CI: 68-98%). The median number of sessions needed to achieve the deisred outcome was one (ranging between 1 and 6 sessions). CONCLUSION: The new version of SOC, SpyGlass DS, provides a feasible and an effective option for the management of difficult cholelithiasis, as well as visually evaluating and obtaining histological samples for indeterminate biliary strictures. However, data from more extensive studies are needed to establish its non-inferiority to the fiberoptic version in terms of short- and long-term outcomes, cost-effectiveness, and complications.

The utility of esophagogastroduodenoscopy and Helicobacter pylori screening in the preoperative assessment of patients undergoing bariatric surgery: A cross-sectional, single-center study in Saudi Arabia.

BACKGROUND/AIM: Esophagogastroduodenoscopy (EGD) and Helicobacter pylori screening are routine parts of the preoperative assessment of patients undergoing bariatric surgery at many centers around the world. The reason for this step is to identify abnormalities that may change the surgical approach. In this study, we aim to evaluate the extent to which endoscopic findings and H. pylori testing affect the plan of care in bariatric patients. PATIENTS AND METHODS: We retrospectively reviewed the investigational processes of 356 patients planned for bariatric surgery (2014-2016) at our center. Patients were categorized into two main groups (4 subgroups) from endoscopic findings. One group included patients with normal EGD and patients who had abnormal findings that did not change the surgical approach, whereas the other included patients who had findings that changed or canceled the surgical plan. A logistic regression analysis was used to evaluate how strongly can factors such as patient demographics, BMI, comorbidities, symptomatology, and H. pylori status predict the risk of having plan-changing endoscopic abnormalities. RESULTS: The ages ranged between 15 and 66 years with a mean ± SD of 37 ± 11 years, and 56% were females. The majority of patients (75%; 95% CI: 73 - 82%) had either no findings (41%) or had abnormalities that did not change the surgical approach (34%). Only 25% (95% CI: 21-29%) were found to have pathologies that altered the surgical approach, and 0.6% of them had findings that were considered contraindications for surgery. In spite the relatively high prevalence of H. pylori in our cohort (41%; 95% CI 36-46%), the proportion of patients who had plan-changing abnormalities did not differ markedly from other studies. Gastroesophageal reflux disease (GERD) and obstructive sleep apnea symptoms were the only significant predictors of EGD findings (P = 0.009). CONCLUSIONS: GERD and sleep apnea symptoms can be strong predictors of EGD abnormalities. However, this evidence is still not enough to safely recommend changing the current practice. Therefore, until a sensitive clinical prediction score is derived and validated according to the symptoms, we suggest that EGD should continue as the standard of care in all patients undergoing bariatric surgery.

Acute Pancreatitis: An Exploratory, Cross-sectional, Single-center Study of the Epidemiological Features of the Disease in a Sample of Saudi Patients.

Epidemiological studies on Acute Pancreatitis (AP) are significantly scarce in the Saudi Arabian Literature. In this paper, we aim to explore the current trends of AP in a sample of Saudi patients. This is a cross-sectional study in which we reviewed AP-related admissions from 2014 to 2017. Data collected included demographics, clinical presentation, investigations, severity, complications, and the outcome at the end of hospitalization. During the study period, 107 patients were admitted due to AP. Fifty-seven (53%) were males. Biliary pancreatitis was the most common etiology found among our patients (39.3%; 95% CI: 30.5-48.7), followed by alcoholic pancreatitis (11.2%; 95% CI: 6.5-18.6) and hypertriglyceridemia (8%; 95% CI: 4.5-15.2). Pancreatic pseudocysts were the most common complication we found in this series (15%; 95% CI: 9.4-23). Of all the hospitalized patients in this study, eight patients (7.9%) died (95% CI: 3.8-14.1). The number of AP-related admissions and mortality rate appear to have increased as compared with the numbers in earlier national studies. The etiological groups have also changed. As compared with Western/Asian studies, however, there was almost no difference in the epidemiological patterns except for the mortality rate.

Prediction of life-story narrative for end-of-life surrogate's decision-making is inadequate: a Q-methodology study.

BACKGROUND: Substituted judgment assumes adequate knowledge of patient's mind-set. However, surrogates' prediction of individual healthcare decisions is often inadequate and may be based on shared background rather than patient-specific knowledge. It is not known whether surrogate's prediction of patient's integrative life-story narrative is better. METHODS: Respondents in 90 family pairs (30 husband-wife, 30 parent-child, 30 sibling-sibling) rank-ordered 47 end-of-life statements as life-story narrative measure (Q-sort) and completed instruments on decision-control preference and healthcare-outcomes acceptability as control measures, from respondent's view (respondent-personal) and predicted pair's view (respondent-surrogate). They also scored their confidence in surrogate's decision-making (0 to 4 = maximum) and familiarity with pair's healthcare-preferences (1 to 4 = maximum). Life-story narratives' prediction was examined by calculating correlation of statements' ranking scores between respondent-personal and respondent-surrogate Q-sorts (projection) and between respondent-surrogate and pair-personal Q-sorts before (simulation) and after controlling for correlation with respondent-personal scores (adjusted-simulation), and by comparing percentages of respondent-surrogate Q-sorts co-loading with pair-personal vs. respondent-personal Q-sorts. Accuracy in predicting decision-control preference and healthcare-outcomes acceptability was determined by percent concordance. Results were compared among subgroups defined by intra-pair relationship, surrogate's decision-making confidence, and healthcare-preferences familiarity. RESULTS: Mean (SD) age was 35.4 (10.3) years, 69% were females, and 73 and 80% reported ≥ very good health and life-quality, respectively. Mean surrogate's decision-making confidence score was 3.35 (0.58) and 75% were ≥ familiar with pair's healthcare-preferences. Mean (95% confidence interval) projection, simulation, and adjusted-simulation correlations were 0.68 (0.67-0.69), 0.42 (0.40-0.44), and 0.26 (0.24-0.28), respectively. Out of 180 respondent-surrogate Q-sorts, 24, 9, and 32% co-loaded with respondent-personal, pair-personal, or both Q-sorts, respectively. Accuracy in predicting decision-control preference and healthcare-outcomes acceptability was 47 and 52%, respectively. Surrogate's decision-making confidence score correlated with adjusted-simulation's correlation score (rho = 0.18, p = 0.01). There were significant differences among the husband-wife, parent-child, and sibling-sibling subgroups in percentage of respondent-surrogate Q-sorts co-loading with pair-personal Q-sorts (38, 32, 55%, respectively, p = 0.03) and percent agreement on healthcare-outcomes acceptability (55, 35, and 67%, respectively, p = 0.002). CONCLUSIONS: Despite high self-reported surrogate's decision-making confidence and healthcare-preferences familiarity, family surrogates are variably inadequate in simulating life-story narratives. Simulation accuracy may not follow the next-of-kin concept and is 38% based on shared background.

ERCP quality indicators: The experience of a high-volume tertiary care center in Saudi Arabia.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most technically demanding and high-risk procedures performed by GI endoscopists. Therefore, guidelines or position statements on various aspects of quality indicators, safety indicators and credentialing for ERCP have been developed by gastroenterology associations. In this paper, we evaluate the ERCP quality in a single, high-volume, tertiary care center in Saudi Arabia using a number of measures commonly stated by these organizations, and compare the experience of that center to the previously-published standards in this regard. PATIENTS AND METHODS: This is a descriptive, retrospective chart review of a consecutive sample taken over 12 continuous months (July 2016-June 2017). Data collected included demographic characteristics, and technical/clinical details from three time periods: preprocedure, intraprocedure, and postprocedure. Measurement parameters were all taken from the ASGE/ACG guidelines. Data was represented by the percentage of which each indicator was achieved, and the 95% proportion confidence intervals (CIs) when needed. RESULTS: From July 2016 to June 2017, 281 ERCP procedures were performed. An outstanding majority of them (95.7%) was done for therapeutic purposes, whereas 4.3% were diagnostic procedures. The sample included 206 patients, of whom 83 (40.3%) were males. The age of the participants ranged between 11 and 101 years (mean age ±â€¯SD; 51 ±â€¯19). The quality of ERCP at the center in which the study was done met the performance targets stated by the ASGE/ACG for almost all indicators. Adverse events reported in our series were lower than previous studies for pancreatitis and perforation, and slightly higher in the incidence of bleeding, cholangitis, and death. CONCLUSION: In a single, high-volume, tertiary care center in Saudi Arabia, the quality of ERCP met the performance targets stated by the ASGE/ACG for almost all indicators.

Endoscopic biodegradable stents as a rescue treatment in the management of post bariatric surgery leaks: a case series.

BACKGROUND AND AIMS: Postoperative leak is one of the most feared complications after bariatric surgery. Endoscopic stenting is used to manage leaks by decreasing the gastrointestinal intraluminal pressure. The main advantage of endoscopic management is providing healing while still allowing for oral nutrition. However, limited literature exists on whether biodegradable stents can be used to control leaks when conventional metallic stents fail. METHODS: Our series consists of four patients who were found to have a leak as a complication of bariatric surgery. Two patients were initially managed by abdominal/chest drainage, and one required total parenteral nutrition. Conventional endoscopic exclusion techniques with short and long fully covered metallic stents were tried and failed in three of the four patients included in this series. Thus, biodegradable stents were used as a rescue option. RESULTS: Biodegradable stents provided immediate improvement for all of the patients, and Gastrografin studies were leak-free 2 days after the procedure. All patients were started on oral feeding and discharged home within 5 - 6 days later. Minimum outpatient follow-up of 8 weeks was achieved with no issues. Follow-up endoscopy was performed 2 - 3 months later in three patients and showed completely resorbed stents. The only drawback was the mucosal reaction to the stent causing dysphagia in two patients, who eventually needed esophageal dilatation. CONCLUSION: Biodegradable stents have the potential to provide a reasonable rescue option to manage post bariatric surgery leaks in patients who fail conventional endoscopic exclusion methods. However, data from larger studies are needed to collect information on which theoretical advantages/disadvantages of degradable biomaterials apply to real practice.