Hemostatic Powder vs Standard Endoscopic Treatment for Gastrointestinal Tumor Bleeding: A Multicenter Randomized Trial.

BACKGROUND & AIMS: Current guidelines vary as to their recommendations addressing the role of hemostatic powders when managing patients with malignant gastrointestinal (GI) bleeding because these are based on very-low- to low-quality evidence, in large part due to a paucity of randomized trial data. METHODS: This was a patient- and outcome assessor-blinded, multicenter, randomized controlled trial. Patients presenting with active bleeding from an upper or lower GI lesion suspected to be malignant at index endoscopy between June 2019 and January 2022 were randomly allocated to receive either TC-325 alone or standard endoscopic treatment (SET). The primary outcome was 30-day rebleeding, and secondary objectives included immediate hemostasis and other clinically relevant endpoints. RESULTS: Overall, 106 patients made up the study population (55 TC-325 and 51 SET, after 1 exclusion in the TC-325 group and 5 in the SET group). Baseline characteristics and endoscopic findings did not differ between the groups. Thirty-day rebleeding was significantly lower in the TC-325 (2.1% TC-325 vs 21.3% SET; odds ratio, 0.09; 95% confidence interval [CI], 0.01-0.80; P = .003). Immediate hemostasis rates were 100% in the TC-325 group vs 68.6% in the SET group (odds ratio, 1.45; 95% CI, 0.93-2.29; P < .001). Other secondary outcomes did not differ between the 2 groups. Independent predictors of 6-month survival included the Charlson comorbidity index (hazard ratio, 1.17; 95% CI, 1.05-1.32; P = .007) and receiving an additional nonendoscopic hemostatic or oncologic treatment during 30 days after the index endoscopy (hazard ratio, 0.16; 95% CI, 0.06-0.43; P < .001) after adjustment for functional status, Glasgow-Blatchford score, and an upper GI source of bleeding. CONCLUSION: The TC-325 hemostatic powder results in greater immediate hemostasis rates followed by lower 30-day rebleeding rates when compared to contemporary SET. (ClinicalTrials.gov, Number: NCT03855904).

The Efficacy of Metoclopramide for Gastric Visualization by Endoscopy in Patients With Active Upper Gastrointestinal Bleeding: Double-Blind Randomized Controlled Trial.

INTRODUCTION: The 2021 American College of Gastroenterology Guidelines suggested using of intravenous erythromycin before endoscopy in patients with upper gastrointestinal bleeding (UGIB) to enhance endoscopic view and reduce the need for repeat endoscopy. Evidence on intravenous metoclopramide, which is more accessible, is scant, especially in patients with active UGIB. This study aimed to evaluate the efficacy of metoclopramide for gastric visualization in patients with active UGIB. METHODS: Between April 10, 2021, and October 8, 2022, this double-blind, double-center randomized controlled trial enrolled patients with active UGIB (hematemesis or presence of fresh blood in the nasogastric tube). The eligible patients were randomly assigned in a concealed 1:1 allocation to metoclopramide or placebo. The primary outcome was adequate visualization by objective endoscopic visualized gastroduodenal scores (EVS). Secondary outcomes included mean difference in EVS, duration of esophagogastroduodenoscopy (EGD), immediate hemostasis, need for a second look EGD, units of blood transfusion, length of hospital stay, and 30-day rebleeding rate. RESULTS: Of the 68 eligible patients, 3 of each group were excluded by protocol violation. Finally, 62 patients (31 metoclopramide and 31 placebo) were analyzed. The percentage of patients with adequate visualization in metoclopramide and placebo group was 77.4% and 61.6% (odds ratio [OR] 2.16 [0.71-6.58], P = 0.16). The need for a second look EGD in the 72 hours was lower in the metoclopramide group (3.2% vs 22.6%, OR 0.11 [0.01-0.99], P = 0.02), whereas the other secondary outcomes were not different. However, in gastric lesions subgroup analysis, metoclopramide improved the adequate visualization rate (92.9% vs 50%, OR 13 [1.32-128.10], P = 0.03) and mean EVS at fundus (1.79 ± 0.42 vs 1.29 ± 0.72; P = 0.03). DISCUSSION: Metoclopramide did not improve endoscopic visualization but decreased the need for second look EGD in patients with overall active UGIB. It improved gastric visualization in those with UGIB due to gastric lesions, primarily by improving visualization in the fundus ( ClinicalTrials.gov number NCT04771481).

TC-325 Superiority in Malignant Gastrointestinal Bleeding: An Individual Patient Data Meta-Analysis of Randomized Trials.

INTRODUCTION: The efficacy of topical hemostatic agents, recommended for peptic ulcer bleeding, remains poorly characterized in malignant gastrointestinal bleeding (GIB). METHODS: We performed an individual patient data meta-analysis assessing the efficacy of topical hemostatic agents in malignant GIB. The literature was searched using OVID MEDLINE, EMBASE, and ISI Web of Science databases (database inception to November 2023). Only randomized controlled trials (RCTs) comparing topical hemostatic agents with conventional endoscopic modalities in malignant GIB were included. Original RCT patient-level data were obtained. Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines were followed. Quality of the evidence was evaluated using the revised Cochrane risk-of-bias tool and certainty of evidence with the Grading of Recommendations Assessment, Development, and Evaluation approach. The primary outcome was immediate hemostasis; secondary outcomes were 30-day rebleeding and the composite measure of further bleeding (persistent bleeding or 30-day rebleeding). Other outcomes were all-cause mortality, adverse events, and need for additional nonendoscopic treatment. Odds ratios (ORs) from endpoint comparisons were pooled using logistic regression models. RESULTS: Overall, 985 citations were identified; 3 RCTs (n = 160 patients) were included with all assessing TC-325 (Hemospray). TC-325 achieved immediate hemostasis more often than conventional endoscopic modalities (OR 46.6, 95% confidence interval [CI] 5.89-369.1) (low-level certainty). Thirty-day rebleeding (OR 0.28, 95% CI 0.11-0.70) and further bleeding (OR 0.11, 95% CI 0.05-0.26) were both significantly lower with TC-325 (very-low-level certainty). All-cause mortality and need for additional nonendoscopic treatment did not differ between groups. No adverse events were reported. Subgroup analysis confirmed TC-325 superiority in patients with upper GIB. DISCUSSION: TC-325 seems superior to conventional endoscopic therapy in managing patients with malignant GIB. TC-325 results in improvements in immediate hemostasis, 30-day rebleeding, and further bleeding, based on very low-to-low certainties of evidence.

Consensus statements on endoscopic ultrasound-guided tissue acquisition. Guidelines from the Asian Endoscopic Ultrasound Group.

OBJECTIVES: This consensus was developed by the Asian EUS Group (AEG), who aimed to formulate a set of practice guidelines addressing various aspects of endoscopic ultrasound-guided tissue acquisition (EUS-TA). METHODS: The AEG initiated the development of consensus statements and formed an expert panel comprising surgeons, gastroenterologists, and pathologists. Three online consensus meetings were conducted to consolidate the statements and votes. The statements were presented and discussed in the first two consensus meetings and revised according to comments. Final voting was conducted at a third consensus meeting. The Grading of Recommendations, Assessment, Development, and Evaluation system was adopted to define the strength of the recommendations and quality of evidence. RESULTS: A total of 20 clinical questions and statements regarding EUS-TA were formulated. The committee recommended that fine-needle biopsy (FNB) needles be preferred over conventional fine-needle aspiration (FNA) needles for EUS-TA of subepithelial lesions. For solid pancreatic masses, rapid on-site evaluation is not routinely recommended when FNB needles are used. For dedicated FNB needles, fork-tip and Franseen-tip needles have essentially equivalent performance. CONCLUSION: This consensus provides guidance for EUS-TA, thereby enhancing the quality of EUS-TA.

Use of over-the-scope clip (OTSC) versus standard therapy for the prevention of rebleeding in large peptic ulcers (size ≥1.5 cm): an open-labelled, multicentre international randomised controlled trial.

INTRODUCTION: Over-the-scope clip (OTSC) has been used recently for primary haemostasis of peptic ulcers. This study aimed to compare the efficacy of OTSC to standard endoscopic therapy in primary treatment of patients with peptic ulcer bleeding that are of size ≥1.5 cm. The target population accounts for only 2.5% of all upper GI bleeders. METHODS: This was a multicentre international randomised controlled trial from July 2017 to October 2020. All patients with Forest IIa or above peptic ulcers of ≥1.5 cm were included. Primary outcome was 30-day clinical rebleeding. Secondary endpoints include 3-day all-cause mortality, transfusion requirement, hospital stay, technical and clinical success, and further interventions. 100 patients are needed to yield a power of 80% to detect a difference of -0.15 at the 0.05 significance level (alpha) using a two-sided Z-test (pooled). RESULTS: 100 patients were recruited. Success in achieving primary haemostasis was achieved in 46/50 (92%) and 48/50 (96%) in the OTSC and conventional arm, respectively. Among patients who had success in primary haemostasis, 2/46 (4.35%) patients in the OTSC arm and 9/48 (18.75%) patients in the conventional arm developed 30-day rebleeding (p=0.03). However, in an intention-to-treat analysis, there was no difference in rebleeding within 30 days (5/50 (10%) OTSC vs 9/50 (18%) standard, p=0.23) or all-cause mortality (2/50 (4%) OTSC vs 4/50 (8%) standard, p=0.68; OR=2.09, 95% CI 0.37 to 11.95). There was also no difference in transfusion requirement, hospital stay, intensive care unit admission and further interventions. CONCLUSION: The routine use of OTSC as primary haemostasis in large bleeding peptic ulcers was not associated with a significant decrease in 30-day rebleeding. TRIAL REGISTRATION NUMBER: NCT03160911.

The comparison of aerosol exposures to endoscopy personnel performing diagnostic upper gastrointestinal endoscopy in patients with and without head box: A randomized control trial.

BACKGROUND AND AIMS: Esophagogastroduodenoscopy (EGD) has been identified as an aerosol-generating procedure (AGP) during the COVID-19 pandemic. The risk of AGP and benefits of utilizing protective measures have never been fully studied. METHODS: A randomized control, open-label study in patients scheduled for diagnostic EGD between September and December 2021 was conducted. Patients were randomly assigned to either head box group or without head box group (control group). Particles were measured with six-size particle counters at the nurse anesthetist and endoscopist position. Primary composite outcomes were the mean difference of aerosol particle levels during and before EGD at the nurse anesthetist face position and at the endoscopist face position. Secondary outcomes were factors increasing aerosol particle levels and safety of the head box. RESULTS: From 196 enrolled patients, 190 were analyzed. Baseline characteristics were not different between the two groups. The mean distance between endoscopist face and patient mouth was 67.2 ± 4.9 cm. The mean differences of 0.3-, 0.5-, and 1.0-µm particles during the procedure and at baseline before the procedure at nurse anesthetist position and the mean differences of 0.3-µm particles at the endoscopist position was found to have decreased in the head box group and increased in the control group (P < 0.001, 0.001, 0.014, and P < 0.001, respectively). Cough, burping, and body movement increased aerosol particles. No additional adverse events were observed in the head box group. CONCLUSIONS: EGD with the head box is safe and can reduce significant aerosolization to endoscopy personnel including nurse anesthetists and endoscopists.

Diagnostic validity and learning curve of non-NBI expert endoscopists in gastric intestinal metaplasia diagnosis.

BACKGROUND: Endoscopists' experience influences narrow-band imaging (NBI)-guided gastric intestinal metaplasia (GIM) diagnostic performance. We aimed to evaluate the general gastroenterologists (GE) performance in NBI-guided GIM diagnosis compared to NBI experts (XP) and assess GEs' learning curve. METHODS: A cross-sectional study was conducted between 10/2019 and 2/2022. Histology-proven GIM who underwent esophagogastroduodenoscopy (EGD) were randomly assessed by 2XPs or 3GEs. Endoscopists' performance on NBI-guided diagnoses were compared to the pathological diagnosis (gold standard) in five areas of the stomach according to the Sydney protocol. The primary outcome were GIM diagnosis validity scores of GEs compared to XPs. The secondary outcome was the minimum number of lesions required for GEs to achieve an accuracy of GIM diagnosis ≥ 80%. RESULTS: One thousand one hundred and fifty-five lesions from 189 patients (51.3% male, mean age 66 ± 10 years) were examined. GEs performed EGD in 128 patients with 690 lesions. the GIM diagnosis sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of GEs compared to the XPs, were 91% vs.93%, 73% vs.83%, 79% vs.83%, 89% vs.93%, and 83% vs.88%, respectively. GEs demonstrated lower specificity (mean difference - 9.4%; 95%CI - 16.3, 1.4; p = 0.008) and accuracy (mean difference - 5.1%; 95%CI - 3.3, 6.3; p = 0.006) compared to XPs. After 100 lesions (50% GIM), GEs achieved an accuracy of ≥ 80% and all diagnostic validity scores were comparable to the XPs (p < 0.05 all). CONCLUSIONS: Compared to XPs, GEs had lower specificity and accuracy for GIM diagnosis. The learning curve for a GE to achieve comparable performance to XPs would necessitate at least 50 GIM lesions. Created with BioRender.com.

Comparison of a Hemostatic Powder and Standard Treatment in the Control of Active Bleeding From Upper Nonvariceal Lesions : A Multicenter, Noninferiority, Randomized Trial.

BACKGROUND: The effectiveness of the hemostatic powder TC-325 as a single endoscopic treatment for acute nonvariceal upper gastrointestinal bleeding is uncertain. OBJECTIVE: To compare TC-325 with standard endoscopic hemostatic treatments in the control of active bleeding from nonvariceal upper gastrointestinal causes. DESIGN: One-sided, noninferiority, randomized, controlled trial. (ClinicalTrials.gov: NCT02534571). SETTING: University teaching hospitals in the Asia-Pacific region. PATIENTS: 224 adult patients with acute bleeding from a nonvariceal cause on upper gastrointestinal endoscopy. INTERVENTION: TC-325 (n = 111) or standard hemostatic treatment (n = 113). MEASUREMENTS: The primary outcome was control of bleeding within 30 days. Other outcomes included failure to control bleeding during index endoscopy, recurrent bleeding after initial hemostasis, further interventions, blood transfusion, hospitalization, and death. RESULTS: 224 patients were enrolled (136 with gastroduodenal ulcers [60.7%], 33 with tumors [14.7%], and 55 with other causes of bleeding [24.6%]). Bleeding was controlled within 30 days in 100 of 111 patients (90.1%) in the TC-325 group and 92 of 113 (81.4%) in the standard treatment group (risk difference, 8.7 percentage points [1-sided 95% CI, 0.95 percentage point]). There were fewer failures of hemostasis during index endoscopy with TC-325 (3 [2.7%] vs. 11 [9.7%]; odds ratio, 0.26 [CI, 0.07 to 0.95]). Recurrent bleeding within 30 days did not differ between groups (9 [8.1%] vs. 10 [8.8%]). The need for further interventions also did not differ between groups (further endoscopic treatment: 8 [7.2%] vs. 10 [8.8%]; angiography: 2 [1.8%] vs. 4 [3.5%]; surgery: 1 [0.9%] vs. 0). There were 14 deaths in each group (12.6% vs. 12.4%). LIMITATION: Clinicians were not blinded to treatment. CONCLUSION: TC-325 is not inferior to standard treatment in the endoscopic control of bleeding from nonvariceal upper gastrointestinal causes. PRIMARY FUNDING SOURCE: General Research Fund to the University Grants Committee, Hong Kong SAR Government.

Viscoelastometric versus standard coagulation tests to guide periprocedural transfusion in adults with cirrhosis: A meta-analysis of randomized controlled trials.

BACKGROUND AND OBJECTIVES: Due to rebalanced haemostasis in cirrhosis, viscoelastometric testing (VET) is more accurate than standard coagulation tests (SCTs) in preprocedural haemostatic evaluation, resulting in decreased unnecessary transfusion. We aimed to determine the impact of VET-guided strategy on postprocedural bleeding, periprocedural transfusion rates and quantities, transfusion-related adverse events (TRAEs), lengths of stay (LOS) and mortality from randomized controlled trials (RCTs) of cirrhotic patients. METHODS: PubMed and EMBASE were searched for RCTs comparing VET-guided with SCT-guided transfusion in cirrhotic adults undergoing esophagogastroduodenoscopy, liver transplantation or other invasive interventions. Using random-effects models, the pooled risk ratios (RRs) and/or mean differences (MDs) of postprocedural bleeding-free events and the other outcomes were estimated alongside 95% confidence intervals (CIs). RESULTS: Of seven included RCTs (n = 421; 72.2% men; mean age 49.1 years), VET-guided transfusion did not change postprocedural bleeding-free statuses (RR 1.05; 95% CI 0.94-1.17). However, VET-based algorithms decreased the rates of fresh frozen plasma (FFP; RR 0.52; 95% CI 0.35-0.77) and platelet transfusions (RR 0.34; 95% CI 0.16-0.73), the quantities of transfused FFP (MD -1.39 units; 95% CI -2.18 to -0.60), platelets (MD -1.06 units; 95% CI -2.01 to -0.12) and cryoprecipitate (MD -7.13 units; 95% CI -14.20 to -0.07) and the risk of TRAEs (RR 0.42; 95% CI 0.27-0.65). The overall mortality rates and LOS were not significantly different between two groups. CONCLUSION: Compared with conventional SCT-guided, VET-guided strategy decreases periprocedural plasma and platelet transfusions and TRAEs, without increasing haemorrhagic complications, LOS or mortality in cirrhosis.

Risk factors of active upper gastrointestinal bleeding in patients with COVID-19 infection and the effectiveness of PPI prophylaxis.

BACKGROUND: Gastrointestinal (GI) bleeding is one of the most impactful complications in patients hospitalized from COVID-19 infection. Limited study has focused on patients with upper GI bleeding (UGIB). This study aimed to identify the risk factors of patients who were hospitalized from COVID-19 infection and developed UGIB as well as the effectiveness of proton pump inhibitor (PPI) prophylaxis in those patients. METHODS: This study was comprised of two phases. The first phase was the retrospective enrollment of patients who were admitted due to COVID-19 infection and developed UGIB between April and August 2021 to evaluate the associated factors of active UGIB. The second phase was a retrospective analysis after PPI prophylaxis protocol from September - October 2021 to assess the benefit of PPI use in those patients. RESULTS: Of 6,373 patients hospitalized, 43 patients (0.7%) had evidence of UGIB. The majority were male 28 (65.1%) with a mean age of 69.1 ± 11.8 years. Twenty-four of 43 patients (55.8%) needed mechanical ventilation, 35 patients (81.4%) received systemic corticosteroids, and 10 patients (23.3%) were taking anticoagulants for venous thromboembolic prophylaxis. Seven of 43 patients (16%) had active UGIB. There was no significant difference in the number of patients taking antiplatelets, anticoagulants, or steroids and the severity of COVID-19 infection between the two groups. An emergency endoscopy or endoscopic hemostasis were performed in 6/7 (85.7%) patients. The multivariate logistic regression analysis revealed two significant factors associated with active UGIB including higher of Glasgow-Blatchford score (GBS) per point (OR = 7.89; 95%CI 1.03-72.87; p = 0.04) and an absence of PPI use (OR 4.29; 95%CI 1.04-19.51; p = 0.04). After prescribing PPI as a prophylaxis, there was a slightly lower incidence of UGIB (0.6% vs 0.7%) in addition to an absence of active UGIB (0% vs 16%). CONCLUSION: Our study demonstrated that the absence of PPI and higher GBS were significant risk factors for active UGIB which required therapeutic endoscopy in patients with COVID-19 infection. We suggest that short-term PPI prophylaxis should be prescribed in those patients once they need hospitalization regardless of the severity of COVID-19 infection to minimize the severity of UGIB.

Thailand guideline 2020 for medical management of gastroesophageal reflux disease.

Gastroesophageal reflux disease (GERD) is one of the most prevalent and bothersome functional gastrointestinal disorders worldwide, including in Thailand. After a decade of the first Thailand GERD guideline, physician and gastroenterologist encountered substantially increase of patients with GERD. Many of them are complicated case and refractory to standard treatment. Concurrently, the evolution of clinical characteristics as well as the progression of investigations and treatment have developed and changed tremendously. As a member of Association of Southeast Asian Nations, which are developing countries, we considered that the counterbalance between advancement and sufficient economy is essential in taking care of patients with GERD. We gather physicians from university hospitals, as well as internist and general practitioners who served in rural area, to make a consensus in this updated version of GERD guideline focusing in medical management of GERD. This clinical practice guideline was constructed adhering with standard procedure. We categorized the guideline in to four parts including definition, investigation, treatment, and long-term follow up. We anticipate that this guideline would improve physicians' proficiency and help direct readers to choose investigations and treatments in patients with GERD wisely. Moreover, we wish that this guideline would be applicable in countries with limited resources as well.

Diagnostic performance of digital and video cholangioscopes in patients with suspected malignant biliary strictures: a systematic review and meta-analysis.

BACKGROUND: Per-oral cholangioscopy (POC) has evolved over the past decade from fiberoptic to digital and video imaging systems. Nowadays, only direct per-oral cholangioscopy (DPOC) and digital single-operator cholangioscopy (DS) are performed in daily practice. With better image resolution, POC is increasingly used as diagnostic tools in patients with suspected malignant biliary stricture (MBS). We aimed to evaluate the diagnostic yield of digital/video cholangioscopes for the diagnosis of MBS. METHODS: A systematic search was performed in MEDLINE, Embase, and ISI Web of Knowledge databases until April 2020, to identify randomized controlled trials and prospective studies using digital or video POC. The meta-analysis of diagnostic accuracy study was performed to calculate summary estimates of the primary outcomes, including pooled sensitivity, and specificity of POC to diagnose MBS using bivariate random-effects models. Tissue histopathology was used as the reference standard for MBS diagnosis. For benign stricture, negative tissue histopathology and at least 6 months clinical follow-up were required. RESULTS: Thirteen original articles with 876 patients were identified. The overall pooled sensitivity and specificity were 88 (95% CI 83-91) and 95 (95% CI 89-98), respectively. The area under the curve (AUROC) was 0.94 (95% CI 0.92-0.96). Subgroup analysis showed that cholangioscopic image impression provided significantly higher sensitivity (93% (95% CI 88-96) vs 82% (95% CI 76-87); p = 0.007), but lower specificity 86% (95% CI 75-92) vs 98 (95% CI 95-99); p < 0.001) than the tissue diagnosis from cholangioscopic-guided biopsy. In addition, biopsy obtained from DPOC had significantly higher sensitivity than that of DS (92% (95% CI 81-97) vs 79% (95% CI 72-84); p = 0.004). Diagnostic performance under image-enhanced endoscopy was not significantly better from white light endoscopy. CONCLUSIONS: Digital/video POC has very high diagnostic performance to diagnose MBS. While image diagnosis provides higher sensitivity than biopsy, its specificity drops as a trade-off.

Scheduled second look endoscopy after endoscopic hemostasis to patients with high risk bleeding peptic ulcers: a Randomized Controlled Trial.

BACKGROUND: The recommendation of second look endoscopy (SLOGD) in selected patients at high risk for rebleeding has been inconclusive. This study aimed to evaluate the benefit of SLOGD in selected patients predicted at high risk of recurrent bleeding. METHODS: From a cohort of 939 patients with bleeding peptic ulcers who underwent endoscopic hemostasis, we derived a 9-point risk score (age > 60, Male, ulcer ≥ 2 cm in size, posterior bulbar or lesser curve gastric ulcer, Forrest I bleeding, haemoglobin < 8 g/dl) to predict recurrent bleeding. We then validated the score in another cohort of 1334 patients (AUROC 0.77). To test the hypothesis that SLOGD in high-risk patients would improve outcomes, we did a randomized controlled trial to compare scheduled SLOGD with observation alone in those predicted at high risk of rebleeding (a score of ≥ 5). The primary outcome was clinical bleeding within 30 days of the index bleed. RESULTS: Of 314 required, we enrolled 157 (50%) patients (SLOGD n = 78, observation n = 79). Nine (11.8%) in SLOGD group and 14 (18.2%) in observation group reached primary outcome (absolute difference 6.4%, 95% CI - 5.0% to 17.8%). Twenty-one of 69 (30.4%) patients who underwent SLOGD needed further endoscopic treatment. No surgery for bleeding control was needed. There were 6 vs. 3 of 30-day deaths in either group (p = 0.285, log rank). No difference was observed regarding blood transfusion and hospitalization. CONCLUSIONS: In this aborted trial that enrolled patients with bleeding peptic ulcers at high-risk of recurrent bleeding, scheduled SLOGD did not significantly improve outcomes. CLINICALTRIALS: gov:NCT02352155.

Differences in Gut Microbiota in Patients With vs Without Inflammatory Bowel Diseases: A Systematic Review.

BACKGROUND & AIMS: Altering the intestinal microbiota has been proposed as a treatment for inflammatory bowel diseases (IBDs), but there are no established associations between specific microbes and IBD. We performed a systematic review to identify frequent associations. METHODS: We searched the MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials databases, through April 2, 2018 for studies that compared intestinal microbiota (from fecal or colonic or ileal tissue samples) among patients (adult or pediatric) with IBD vs healthy individuals (controls). The primary outcome was difference in specific taxa in fecal or intestinal tissue samples from patients with IBD vs controls. We used the Newcastle-Ottawa scale to assess the quality of studies included in the review. RESULTS: We identified 2631 citations; 48 studies from 45 articles were included in the analysis. Most studies evaluated adults with Crohn's disease or ulcerative colitis. All 3 studies of Christensenellaceae and Coriobacteriaceae and 6 of 11 studies of Faecalibacterium prausnitzii reported a decreased amount of those organisms compared with controls, whereas 2 studies each of Actinomyces, Veillonella, and Escherichia coli revealed an increased amount in patients with Crohn's disease. For patients with ulcerative colitis, Eubacterium rectale and Akkermansia were decreased in all 3 studies, whereas E coli was increased in 4 of 9 studies. The microbiota diversity was either decreased or not different in patients with IBD vs controls. Fewer than 50% of the studies stated comparable sexes and ages of cases and controls. CONCLUSIONS: In a systematic review, we found evidence for differences in abundances of some bacteria in patients with IBD vs controls, but we cannot make conclusions due to inconsistent results and methods among studies. Further large-scale studies, with better methods of assessing microbe populations, are needed.

Amount of contamination on the face shield of endoscopists during upper endoscopy between patients in two positions: A randomized study.

BACKGROUND AND AIM: During the Coronavirus Disease 2019 pandemic, esophagogastroduodenoscopy (EGD) has been recognized as an aerosol-generating procedure. This study aimed to systematically compare the degree of face shield contamination between endoscopists who performed EGD on patients lying in the left lateral decubitus (LL) and prone positions. METHODS: This is a randomized trial in patients scheduled for EGD between April and June 2020. Eligible 212 patients were randomized with 1:1 allocation. Rapid adenosine triphosphate test was used to determine contamination level using relative light units of greater than 200 as a cutoff value. All eligible patients were randomized to lie in either the LL or prone position during EGD. The primary outcome was the rate of contamination on the endoscopist's face shield. RESULTS: The majority of patients were female (63%), with a mean age of 60 ± 13 years. Baseline characteristics were comparable between the two groups. There was no face shield contamination after EGD in either group. The number of coughs in the LL group was higher than the prone group (1.38 ± 1.8 vs 0.89 ± 1.4, P = 0.03). The mean differences in relative light units on the face shield before and after EGD in the LL and prone groups were 9.9 ± 20.9 and 4.1 ± 6 (P = 0.008), respectively. CONCLUSION: As measured by the adenosine triphosphate test, performing diagnostic EGD does not lead to contamination on the face shield of the endoscopist. However, placing patients in the prone position may further mitigate the risk.

Gut Microbiota in Patients With Irritable Bowel Syndrome-A Systematic Review.

BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is common but difficult to treat. Altering the gut microbiota has been proposed as a strategy for treatment of IBS, but the association between the gut microbiome and IBS symptoms has not been well established. We performed a systematic review to explore evidence for this association. METHODS: We searched databases, including MEDLINE, EMBASE, Cochrane CDSR, and CENTRAL, through April 2, 2018 for case-control studies comparing the fecal or colon microbiomes of adult or pediatric patients with IBS with microbiomes of healthy individuals (controls). The primary outcome was differences in specific gut microbes between patients with IBS and controls. RESULTS: The search identified 2631 citations; 24 studies from 22 articles were included. Most studies evaluated adults presenting with various IBS subtypes. Family Enterobacteriaceae (phylum Proteobacteria), family Lactobacillaceae, and genus Bacteroides were increased in patients with IBS compared with controls, whereas uncultured Clostridiales I, genus Faecalibacterium (including Faecalibacterium prausnitzii), and genus Bifidobacterium were decreased in patients with IBS. The diversity of the microbiota was either decreased or not different in IBS patients compared with controls. More than 40% of included studies did not state whether cases and controls were comparable (did not describe sex and/or age characteristics). CONCLUSIONS: In a systematic review, we identified specific bacteria associated with microbiomes of patients with IBS vs controls. Studies are needed to determine whether these microbes are a product or cause of IBS.

Diagnostic performance of different cholangioscopes in patients with biliary strictures: a systematic review.

BACKGROUND: Cholangioscopy provides direct intraductual imaging, which can enhance diagnostic efficacy during endoscopic retrograde cholangiopancreatography in patients with biliary strictures. This study aimed to review the diagnostic yield of different cholangioscopes for the diagnosis of malignant biliary stricture (MBS). METHODS: A comprehensive literature review was performed. Full papers of prospective studies using any type of peroral cholangioscope (POC) were included without language restriction. The primary outcomes were sensitivity, specificity, and accuracy of various POCs to diagnose MBS. RESULTS: Data from 20 published articles, involving 1141 patients, were extracted. Overall sensitivities of POCs for diagnosing MBS were higher for the diagnosis made under visual impression compared with those from cholangioscopy-guided biopsy (67 % - 100 % vs. 38 % - 100 %), whereas the overall specificities were generally high and comparable (73 % - 100 % vs. 75 % - 100 %). Newer video cholangioscopes (digital single-operator POC [digital SOC], direct POC) with the exception of video dual-operator mother - baby POC (video DOC), provided better sensitivity of cholangioscopy-guided biopsy compared with fiberoptic scopes (digital SOC 80 % - 85 %, direct POC 80 % - 100 %, video DOC 38 % - 100 %, and fiberoptic SOC 49 % - 100 %, respectively). Among these video cholangioscopes, the digital SOC provided the highest technical success rate, at 100 %. CONCLUSIONS: POCs enhanced the diagnostic yield for diagnosis of MBS. Compared with fiberoptic POCs that only provide good image impression, the digital SOC and direct POC were good at both image impression and cholangioscopy-guided biopsy to diagnose MBS. To ensure high technical success for MBS diagnosis, the digital SOC is a good option.

Prophylactic angiographic embolisation after endoscopic control of bleeding to high-risk peptic ulcers: a randomised controlled trial.

OBJECTIVES: In the management of patients with bleeding peptic ulcers, recurrent bleeding is associated with high mortality. We investigated if added angiographic embolisation after endoscopic haemostasis to high-risk ulcers could reduce recurrent bleeding. DESIGN: After endoscopic haemostasis to their bleeding gastroduodenal ulcers, we randomised patients with at least one of these criteria (ulcers≥20 mm in size, spurting bleeding, hypotensive shock or haemoglobin<9 g/dL) to receive added angiographic embolisation or standard treatment. Our primary endpoint was recurrent bleeding within 30 days. RESULTS: Between January 2010 and July 2014, 241 patients were randomised (added angiographic embolisation n=118, standard treatment n=123); 22 of 118 patients (18.6%) randomised to angiography did not receive embolisation. In an intention-to-treat analysis, 12 (10.2%) in the embolisation and 14 (11.4%) in the standard treatment group reached the primary endpoint (HR 1.14, 95% CI 0.53 to 2.46; p=0.745). The rate of reinterventions (13 vs 17; p=0.510) and deaths (3 vs 5, p=0.519) were similar. In a per-protocol analysis, 6 of 96 (6.2%) rebled after embolisation compared with 14 of 123 (11.4%) in the standard treatment group (HR 1.89, 95% CI 0.73 to 4.92; p=0.192). None of 96 patients died after embolisation compared with 5 (4.1%) deaths in the standard treatment group (p=0.108). In a posthoc analysis, embolisation reduced recurrent bleeding only in patients with ulcers≥15 mm in size (2 (4.5%) vs 12 (23.1%); p=0.027). CONCLUSIONS: After endoscopic haemostasis, added embolisation does not reduce recurrent bleeding. TRIAL REGISTRATION NUMBER: NCT01142180.

An Asian consensus on standards of diagnostic upper endoscopy for neoplasia.

BACKGROUND: This is a consensus developed by a group of expert endoscopists aiming to standardise the preparation, process and endoscopic procedural steps for diagnosis of early upper gastrointestinal (GI) cancers. METHOD: The Delphi method was used to develop consensus statements through identification of clinical questions on diagnostic endoscopy. Three consensus meetings were conducted to consolidate the statements and voting. We conducted a systematic literature search on evidence for each statement. The statements were presented in the second consensus meeting and revised according to comments. The final voting was conducted at the third consensus meeting on the level of evidence and agreement. RESULTS: Risk stratification should be conducted before endoscopy and high risk endoscopic findings should raise an index of suspicion. The presence of premalignant mucosal changes should be documented and use of sedation is recommended to enhance detection of superficial upper GI neoplasms. The use of antispasmodics and mucolytics enhanced visualisation of the upper GI tract, and systematic endoscopic mapping should be conducted to improve detection. Sufficient examination time and structured training on diagnosis improves detection. Image enhanced endoscopy in addition to white light imaging improves detection of superficial upper GI cancer. Magnifying endoscopy with narrow-band imaging is recommended for characterisation of upper GI superficial neoplasms. Endoscopic characterisation can avoid unnecessary biopsy. CONCLUSION: This consensus provides guidance for the performance of endoscopic diagnosis and characterisation for early gastric and oesophageal neoplasia based on the evidence. This will enhance the quality of endoscopic diagnosis and improve detection of early upper GI cancers.