Effect of Real-Time Computer-Aided Polyp Detection System (ENDO-AID) on Adenoma Detection in Endoscopists-in-Training: A Randomized Trial.

BACKGROUND: The effect of computer-aided polyp detection (CADe) on adenoma detection rate (ADR) among endoscopists-in-training remains unknown. METHODS: We performed a single-blind, parallel-group, randomized controlled trial in Hong Kong between April 2021 and July 2022 (NCT04838951). Eligible subjects undergoing screening/surveillance/diagnostic colonoscopies were randomized 1:1 to receive colonoscopies with CADe (ENDO-AID[OIP-1]) or not (control) during withdrawal. Procedures were performed by endoscopists-in-training with <500 procedures and <3 years' experience. Randomization was stratified by patient age, sex, and endoscopist experience (beginner vs intermediate level, <200 vs 200-500 procedures). Image enhancement and distal attachment devices were disallowed. Subjects with incomplete colonoscopies or inadequate bowel preparation were excluded. Treatment allocation was blinded to outcome assessors. The primary outcome was ADR. Secondary outcomes were ADR for different adenoma sizes and locations, mean number of adenomas, and non-neoplastic resection rate. RESULTS: A total of 386 and 380 subjects were randomized to CADe and control groups, respectively. The overall ADR was significantly higher in the CADe group than in the control group (57.5% vs 44.5%; adjusted relative risk, 1.41; 95% CI, 1.17-1.72; P < .001). The ADRs for <5 mm (40.4% vs 25.0%) and 5- to 10-mm adenomas (36.8% vs 29.2%) were higher in the CADe group. The ADRs were higher in the CADe group in both the right colon (42.0% vs 30.8%) and left colon (34.5% vs 27.6%), but there was no significant difference in advanced ADR. The ADRs were higher in the CADe group among beginner (60.0% vs 41.9%) and intermediate-level (56.5% vs 45.5%) endoscopists. Mean number of adenomas (1.48 vs 0.86) and non-neoplastic resection rate (52.1% vs 35.0%) were higher in the CADe group. CONCLUSIONS: Among endoscopists-in-training, the use of CADe during colonoscopies was associated with increased overall ADR. (ClinicalTrials.gov, Number: NCT04838951).

Single-use accessories and endoscopes in the era of sustainability and climate change-A balancing act.

Gastrointestinal (GI) endoscopy is among the highest waste generator in healthcare facilities. The major reasons include production of large-volume non-renewable waste, use of single-use devices, and reprocessing or decontamination processes. Single-use endoscopic accessories have gradually replaced reusable devices over last two decades contributing to the rising impact of GI endoscopy on ecosystem. Several reports of infection outbreaks with reusable duodenoscopes raised concerns regarding the efficacy and adherence to standard disinfection protocols. Even the enhanced reprocessing techniques like double high-level disinfection have not been found to be the perfect ways for decontamination of duodenoscopes and therefore, paved the way for the development of single-use duodenoscopes. However, the use of single-use endoscopes is likely to amplify the net waste generated and carbon footprint of any endoscopy unit. Moreover, single-use devices challenge one of the major pillars of sustainability, that is, "reuse." In the era of climate change, a balanced approach is required taking into consideration patient safety as well as financial and environmental implications. The possible solutions to provide optimum care while addressing the impact on climate include selective use of disposable duodenoscopes and careful selection of accessories during a case. Other options include use of disposable endcaps and development of effective high-level disinfection techniques. The collaboration between the healthcare professionals and the manufacturers is paramount for the development of environmental friendly devices with low carbon footprint.

Asia-Pacific survey on green endoscopy.

BACKGROUND AND AIM: Greenhouse gas emissions are the fundamental cause of global warming, with CO2 being the most contributive. Carbon reduction has been widely advocated to mitigate the climate crisis. The endoscopy unit is the third highest waste-generating department in a hospital. The awareness and acceptance of the practice of green endoscopy among healthcare workers is unclear. METHOD: An online survey was conducted over a 5-week period from July to August 2023 in the Asia-Pacific region, which targeted endoscopists, nurses, and other healthcare professionals of the endoscopy unit. The primary outcome was the agreement to adopt green endoscopy. The secondary outcomes included views on sustainable practices, factors associated with increased acceptance of green endoscopy, the acceptance of different carbon reduction measures, and the perceived barriers to implementation. RESULTS: A total of 259 valid responses were received. Overall, 79.5% of participants agreed to incorporate green endoscopy into their practice. Nevertheless, existing green policies were only reported by 12.7% of respondents. The level of understanding of green endoscopy is the only significant factor associated with its acceptance (odds ratio 3.10, P < 0.007). Potential barriers to implementation include healthcare cost increment, infection risk, inadequate awareness, and lack of policy and industrial support. CONCLUSION: Green endoscopy is well accepted among healthcare workers but not widely implemented. The level of understanding is highly associated with its acceptance, highlighting the importance of education. A reliable assessment tool is needed to quantify the environmental impact of endoscopy. Further studies are needed to ascertain its benefit and cost effectiveness.

Timing of Endoscopy for Acute Upper Gastrointestinal Bleeding.

BACKGROUND: It is recommended that patients with acute upper gastrointestinal bleeding undergo endoscopy within 24 hours after gastroenterologic consultation. The role of endoscopy performed within time frames shorter than 24 hours has not been adequately defined. METHODS: To evaluate whether urgent endoscopy improves outcomes in patients predicted to be at high risk for further bleeding or death, we randomly assigned patients with overt signs of acute upper gastrointestinal bleeding and a Glasgow-Blatchford score of 12 or higher (scores range from 0 to 23, with higher scores indicating a higher risk of further bleeding or death) to undergo endoscopy within 6 hours (urgent-endoscopy group) or between 6 and 24 hours (early-endoscopy group) after gastroenterologic consultation. The primary end point was death from any cause within 30 days after randomization. RESULTS: A total of 516 patients were enrolled. The 30-day mortality was 8.9% (23 of 258 patients) in the urgent-endoscopy group and 6.6% (17 of 258) in the early-endoscopy group (difference, 2.3 percentage points; 95% confidence interval [CI], -2.3 to 6.9). Further bleeding within 30 days occurred in 28 patients (10.9%) in the urgent-endoscopy group and in 20 (7.8%) in the early-endoscopy group (difference, 3.1 percentage points; 95% CI, -1.9 to 8.1). Ulcers with active bleeding or visible vessels were found on initial endoscopy in 105 of the 158 patients (66.4%) with peptic ulcers in the urgent-endoscopy group and in 76 of 159 (47.8%) in the early-endoscopy group. Endoscopic hemostatic treatment was administered at initial endoscopy for 155 patients (60.1%) in the urgent-endoscopy group and for 125 (48.4%) in the early-endoscopy group. CONCLUSIONS: In patients with acute upper gastrointestinal bleeding who were at high risk for further bleeding or death, endoscopy performed within 6 hours after gastroenterologic consultation was not associated with lower 30-day mortality than endoscopy performed between 6 and 24 hours after consultation. (Funded by the Health and Medical Fund of the Food and Health Bureau, Government of Hong Kong Special Administrative Region; ClinicalTrials.gov number, NCT01675856.).

Artificial Intelligence-Assisted Colonoscopy for Colorectal Cancer Screening: A Multicenter Randomized Controlled Trial.

BACKGROUND AND AIMS: Artificial intelligence (AI)-assisted colonoscopy improves polyp detection and characterization in colonoscopy. However, data from large-scale multicenter randomized controlled trials (RCT) in an asymptomatic population are lacking. METHODS: This multicenter RCT aimed to compare AI-assisted colonoscopy with conventional colonoscopy for adenoma detection in an asymptomatic population. Asymptomatic subjects 45-75 years of age undergoing colorectal cancer screening by direct colonoscopy or fecal immunochemical test were recruited in 6 referral centers in Hong Kong, Jilin, Inner Mongolia, Xiamen, and Beijing. In the AI-assisted colonoscopy, an AI polyp detection system (Eagle-Eye) with real-time notification on the same monitor of the endoscopy system was used. The primary outcome was overall adenoma detection rate (ADR). Secondary outcomes were mean number of adenomas per colonoscopy, ADR according to endoscopist's experience, and colonoscopy withdrawal time. This study received Institutional Review Board approval (CRE-2019.393). RESULTS: From November 2019 to August 2021, 3059 subjects were randomized to AI-assisted colonoscopy (n = 1519) and conventional colonoscopy (n = 1540). Baseline characteristics and bowel preparation quality between the 2 groups were similar. The overall ADR (39.9% vs 32.4%; P < .001), advanced ADR (6.6% vs 4.9%; P = .041), ADR of expert (42.3% vs 32.8%; P < .001) and nonexpert endoscopists (37.5% vs 32.1%; P = .023), and adenomas per colonoscopy (0.59 ± 0.97 vs 0.45 ± 0.81; P < .001) were all significantly higher in the AI-assisted colonoscopy. The median withdrawal time (8.3 minutes vs 7.8 minutes; P = .004) was slightly longer in the AI-assisted colonoscopy group. CONCLUSIONS: In this multicenter RCT in asymptomatic patients, AI-assisted colonoscopy improved overall ADR, advanced ADR, and ADR of both expert and nonexpert attending endoscopists. (ClinicalTrials.gov, Number: NCT04422548).

Effectiveness of prophylactic clipping in preventing postpolypectomy bleeding in aspirin users: a propensity-score analysis.

BACKGROUND AND AIMS: Antithrombotic use is a significant risk factor of postpolypectomy bleeding (PPB). Evidence of prophylactic clipping is only available for proximal and large colonic lesions in the general population. Dedicated studies to examine the benefit of prophylactic clipping in patients on aspirin remain scarce. METHODS: A propensity score-weighted retrospective cohort study was performed in a tertiary referral center from January 2018 to September 2021. Patients who received aspirin and underwent colonoscopic polypectomy, EMR, or endoscopic submucosal dissection were included. Data on baseline demographics, medications, and endoscopic factors (polyp number, size, location, and morphology; resection method; and prophylactic clipping) were captured. Propensity score-weighted models were developed between prophylactic clipping and no clipping groups. The primary outcome was delayed PPB within 30 days, with a composite endpoint consisting of repeated colonoscopy for hemostasis, requirement of blood transfusion, or hemoglobin drop >2 g/dL. RESULTS: A total of 1373 patients with 3952 polyps were included. Baseline characteristics were balanced between the 2 groups. In the multivariate analysis, the largest polyp size was a significant risk factor for PPB (odds ratio, 1.07; 95% confidence interval, 1.02-1.11; P = .002). Prophylactic clipping was not associated with a reduced risk of PPB (odds ratio, 1.34; 95% confidence interval, .83-2.18; P = .240) and did not show any risk reduction in subgroups with different polyp sizes and locations and endoscopic resection techniques. CONCLUSIONS: Prophylactic clipping was not associated with a lower risk of PPB in aspirin users after endoscopic resection of colorectal polyps. Aspirin use should not be regarded as the only factor for the routine use of prophylactic clips.

Risk of recurrent advanced colorectal neoplasia in individuals with baseline non-advanced neoplasia followed up at 5 vs 7-10 years.

BACKGROUND AND AIM: Colorectal cancer (CRC) is one of the commonest cancers, especially among the Asian populations. We compared the recurrence rate of advanced colorectal neoplasia (ACN) at 5 year vs 7-10 years among individuals with non-advanced adenoma (NAA) detected and polypectomized at baseline colonoscopy in a large Chinese population. METHODS: We extracted data of a large Chinese population with NAA polypectomized who received surveillance colonoscopy after 5 or 7-10 years from a large database (2008-2018). The outcome variable included recurrence of ACN at surveillance colonoscopy. We examined the association between length of surveillance and the outcome variable, whilst controlling for risk factors of colorectal cancer. RESULTS: We include 109 768 subjects who have received a baseline colonoscopy from our dataset. They were aged 67.35 (SD 9.84) years, and 60.9% of them were male subjects. The crude 5-year and 10-year recurrence rate of ACN was 1.50% and 2.42%, respectively (crude odds ratio = 1.629, 95% CI 1.362 to 1.949, P < 0.001). From the binary logistic regression model, individuals with surveillance colonoscopy performed at 10 years had a statistically higher recurrence rate of ACN than those followed-up at 5 year (adjusted odds ratio [aOR] = 1.544, 95% CI 1.266 to 1.877, P < 0.001), but the effect size of aOR is small. CONCLUSIONS: There is a small difference in recurrence of ACN between individuals who received colonoscopy workup at 5 years vs 7-10 years. These findings support a 7-10 years surveillance period after baseline NAA was polypectomized.

Impact of COVID-19 infection and vaccination in pancreatobiliary IgG4-related disease patients: An international multicenter study.

BACKGROUND AND AIM: Dedicated studies evaluating the impact of COVID-19 on outcomes of pancreatobiliary IgG4 related disease (IgG4-RD) patients are scarce. Whether COVID-19 infection or vaccination would trigger IgG4-RD exacerbation remains unknown. METHODS: Pancreatobiliary IgG4-RD patients ≥ 18 years old with active follow-up since January 2020 from nine referral centers in Asia, Europe, and North America were included in this multicenter retrospective study. Outcome measures include incidence and severity of COVID-19 infection, IgG4-RD disease activity and treatment status, interruption of indicated IgG4-RD treatment. Prospective data on COVID-19 vaccination status and new COVID-19 infection during the Omicron outbreak were also retrieved in the Hong Kong cohort. RESULTS: Of the 124 pancreatobiliary IgG4-RD patients, 25.0% had active IgG4-RD, 71.0% were on immunosuppressive therapies and 80.6% had ≥ 1 risk factor for severe COVID. In 2020 (pre-vaccination period), two patients (1.6%) had COVID-19 infection (one requiring ICU admission), and 7.2% of patients had interruptions in indicated immunosuppressive treatment for IgG4-RD. Despite a high vaccination rate (85.0%), COVID-19 infection rate has increased to 20.0% during Omicron outbreak in the Hong Kong cohort. A trend towards higher COVID-19 infection rate was noted in the non-fully vaccinated/unvaccinated group (17.6% vs 33.3%, P = 0.376). No IgG4-RD exacerbation following COVID-19 vaccination or infection was observed. CONCLUSION: While a low COVID-19 infection rate with no mortality was observed in pancreatobiliary IgG4-RD patients in the pre-vaccination period of COVID-19, infection rate has increased during the Omicron outbreak despite a high vaccination rate. No IgG4-RD exacerbation after COVID-19 infection or vaccination was observed.

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.

Endoscopic evaluation of indeterminate biliary strictures: Cholangioscopy, endoscopic ultrasound, or both?

Accurate and timely diagnosis of biliary strictures can be challenging. Because the diagnostic sensitivity and accuracy of standard endoscopic retrograde cholangiopancreatography-based tissue sampling for malignancy are suboptimal, additional endoscopic evaluation by cholangioscopy and/or endoscopic ultrasound (EUS) is often necessary to differentiate between malignant and benign biliary strictures to guide clinical management. While direct visualization by cholangioscopy and/or high-resolution imaging by EUS are often the first step in the evaluation of an indeterminate biliary stricture (IDBS), tissue diagnosis by cholangioscopy-guided biopsy and/or EUS-guided fine-needle tissue acquisition is the preferred modality to establish a diagnosis of malignancy. Because each modality has its own strengths and limitations, selection of cholangioscopy and EUS is best guided by the biliary stricture location and local expertise. Artificial intelligence-assisted diagnosis, biopsy forceps with improved design, contrast-enhanced EUS, and dedicated fine-needle biopsy devices are recent technological advances that may further improve the diagnostic performance of cholangioscopy and EUS in patients with IDBS.

Timing of endoscopy for acute upper gastrointestinal bleeding: a territory-wide cohort study.

OBJECTIVE: While it is recommended that patients presenting with acute upper gastrointestinal bleeding (AUGIB) should receive endoscopic intervention within 24 hours, the optimal timing is still uncertain. We aimed to assess whether endoscopy timing postadmission would affect outcomes. DESIGN: We conducted a retrospective, territory-wide, cohort study with healthcare data from all public hospitals in Hong Kong. Adult patients (age ≥18) that presented with AUGIB between 2013 and 2019 and received therapeutic endoscopy within 48 hours (n=6474) were recruited. Patients were classified based on endoscopic timing postadmission: urgent (t≤6), early (6

Two vs One Forward View Examination of Right Colon on Adenoma Detection: An International Multicenter Randomized Trial.

BACKGROUND & AIMS: Second forward view (SFV) examination of the right colon (RC) in colonoscopy was suggested to improve the adenoma detection rate (ADR), but multicenter data to inform its routine use remain limited. We performed an international multicenter randomized trial comparing SFV vs a standard single forward view examination of the RC on adenoma detection. METHODS: Asymptomatic individuals undergoing screening or surveillance colonoscopies from 6 Asia Pacific regions were invited for study. A forward view examination of the RC was first performed in all patients, followed by randomization at the hepatic flexure to either SFV examination of the RC and standard withdrawal examination from the hepatic flexure to rectum, or a standard withdrawal colonoscopy (SWC) examination from the hepatic flexure to rectum. The primary outcome was RC ADR. RESULTS: Between 2016 and 2019, there were 1011 patients randomized (SFV group, 502 patients; SWC group, 509 patients). Forty-five endoscopists performed the colonoscopies. The RC ADR was significantly higher in the SFV group than in the SWC group (27.1% vs 21.6%; P = .042). The whole-colon ADR was high in both groups (49.0% vs 45.0%; P =.201). The SFV examination identified 58 additional adenomas in 49 patients (9.8%), leading to a change in surveillance recommendations in 15 patients (3.0%). The median overall withdrawal time was 1.5 minutes longer in the SFV group (12.0 vs 10.5 min; P < .001). Older age, male sex, ever smoking, and longer RC withdrawal time were independent predictors of right-sided adenoma detection. CONCLUSIONS: In this multicenter trial, SFV examination significantly increased the RC ADR in screening and surveillance colonoscopies. Routine RC SFV examination should be considered. ClinicalTrials.gov ID: NCT03121495.

Effectiveness of prophylactic clipping in preventing postpolypectomy bleeding in oral anticoagulant users: a propensity-score analysis.

BACKGROUND AND AIMS: Evidence of prophylactic clipping is inconsistent except for proximal and large colonic lesions in the general population. Although warfarin and direct oral anticoagulants (DOACs) are significant risk factors of postpolypectomy bleeding (PPB), dedicated studies to examine the benefit of prophylactic clipping in these high-risk patients remain limited. METHODS: We performed a propensity score-weighted retrospective cohort study from 2012 to 2020. Patients who received an oral anticoagulant and underwent colonoscopic polypectomy were included. Data were collected on baseline demographics, medications (anticoagulant, antiplatelet, and heparin bridging), and endoscopies (polyp number, location, size, morphology, histopathology, resection method and prophylactic clipping). Propensity-score models with inverse probability of treatment weighting were developed between prophylactic clipping and no clipping groups. Unbalanced variables were included in a doubly robust model with multivariate analysis. The primary outcome was clinically significant delayed PPB, defined as a composite endpoint of hemoglobin drop ≥2 g/dL, blood transfusion, or repeat colonoscopy for hemostasis within 30 days. RESULTS: Five hundred forty-seven patients with 1485 polyps were included. Prophylactic clipping was not associated with a reduced risk of PPB (odds ratio [OR], 1.19; 95% confidence interval [CI], .73-1.95; P = .497). The hot resection method was associated with a significantly higher risk of PPB (OR, 9.76; 95% CI, 3.94-32.60; P < .001) compared with cold biopsy or snare polypectomy. In a subgroup analysis, prophylactic clipping was associated with a lower PPB risk in patients on DOACs (OR, .36; 95% CI, .16-.82; P = .015). CONCLUSIONS: Prophylactic clipping was not associated with an overall reduced risk of PPB in patients on oral anticoagulants. The use of cold snare polypectomy should be maximized in anticoagulated patients.

Mobile messenger-initiated reminders improve longitudinal adherence in a community-based, opportunistic colorectal cancer screening program: A single-blind, crossover randomized controlled study.

BACKGROUND: The fecal immunochemical test (FIT) is a cost-effective colorectal cancer (CRC) screening tool. However, longitudinal adherence, a factor that is critical to the success to any FIT-based screening program, often is poor. The authors hypothesized that reminders sent via mobile messengers, such as WhatsApp, improve such adherence. METHODS: In the current single-blind, randomized study, subjects from an opportunistic FIT screening program who had a negative FIT result the year prior were randomly allocated (1:1) to receive either a 1-off reminder via the WhatsApp messenger (WR) 1 month prior to the due appointments or no reminder (NR). All subjects were blinded to study participation and group allocation. At 24 months after randomization, a crossover of intervention was performed among those individuals who remained in the FIT program. The primary outcome was FIT adherence, defined as the pick-up and on-time return of the FIT. The secondary outcome was FIT adherence after the crossover. RESULTS: A total of 500 subjects were randomized to receive WR (250 subjects) or NR (250 subjects). Three individuals were excluded from analysis (1 died and 2 underwent colonoscopy). Both the FIT pick-up rate (80.3% vs 59.3%; P < .001) and return rate (79.9% vs 57.3%; P < .001) were significantly higher in the WR group compared with the NR group. After crossover of intervention (452 subjects), the WR group again was found to have a higher FIT pick-up rate (79.1% vs 52.9%; P < .001) and return rate (78.2% vs 52.4%; P < .001). CONCLUSIONS: Text reminders sent via mobile messenger appear to improve the longitudinal adherence to FIT-based opportunistic CRC screening programs. The routine use of this technology in CRC screening should be considered.

Digital single-operator peroral cholangioscopy-guided biopsy sampling versus ERCP-guided brushing for indeterminate biliary strictures: a prospective, randomized, multicenter trial (with video).

BACKGROUND AND AIMS: Accurately diagnosing indeterminate biliary strictures is challenging but important for patient prognostication and further management. Biopsy sampling under direct cholangioscopic vision might be superior to standard ERCP techniques such as brushing or biopsy sampling. Our aim was to investigate whether digital single-operator cholangioscopy (DSOC) compared with standard ERCP workup improves the diagnostic yield in patients with indeterminate biliary strictures. METHODS: Patients with an indeterminate biliary stricture on the basis of MRCP were randomized to standard ERCP visualization with tissue brushing (control arm [CA]) or DSOC visualization and DSOC-guided biopsy sampling (study arm [SA]). This was a prospective, international, multicenter trial with a procedure-blinded pathologist. RESULTS: The first sample sensitivity of DSOC-guided biopsy samples was significantly higher than ERCP-guided brushing (SA 68.2% vs CA 21.4%, P < .01). The sensitivity of visualization (SA 95.5% vs CA 66.7%, P = .02) and overall accuracy (SA 87.1% vs CA 65.5%, P = .05) were significantly higher in the SA compared with the CA, whereas specificity, positive predictive value, and negative predictive value showed no significant difference. Adverse events were equally low in both arms. CONCLUSIONS: DSOC-guided biopsy sampling was shown to be safe and effective with a higher sensitivity compared with standard ERCP techniques in the visual and histopathologic diagnosis of indeterminate biliary strictures. (Clinical trial registration number: NCT03140007.).

Endoscopic ultrasound-guided cyanoacrylate injection to prevent rebleeding in hepatocellular carcinoma patients with variceal hemorrhage.

BACKGROUND AND AIM: Secondary prophylaxis (SP) of variceal rebleeding was reported to improve outcomes of hepatocellular carcinoma (HCC) patients, but the optimal endoscopic approach is not well defined. We compared outcomes in HCC patients who underwent SP by endoscopic ultrasound-guided cyanoacrylate obturation (EUS-CYA) versus no SP. METHODS: Between 2014 and 2018, 30 consecutive patients with inoperable HCC and recent endoscopically controlled variceal bleeding were prospectively recruited. Twenty-seven patients with persistent varices ≥ 3 mm on endoscopic ultrasound underwent EUS-CYA for SP. Thirty-three HCC patients treated by esophagogastroduodenoscopy-guided CYA obturation (EGD-CYA) alone for acute variceal bleeding between 2009 and 2013 were identified from a prospective gastrointestinal bleed registry as standard of care controls for comparison. Outcome measures were death-adjusted cumulative incidence of rebleeding, bleeding-free survival, technical success, and procedure-related adverse events of EUS-CYA. RESULTS: The majority of patients in both groups had advanced HCC, portal vein thrombosis, and Child-Pugh B cirrhosis. EUS-CYA was successful in all 27 patients with no radiographic evidence of cyanoacrylate-lipiodol embolization. Significantly lower 30- and 90-day death-adjusted cumulative incidence of rebleeding (14.8% vs 42.4%, P = 0.023 and 18.5% vs 60.6%, P = 0.002, respectively) and significantly higher variceal bleeding-free survival at 3 and 6 months (51.9% vs 21.2%, P = 0.009, 40.7% vs 15.2%, P = 0.010, respectively) were observed in the EUS-CYA group when compared with standard of care group. CONCLUSIONS: Secondary prophylaxis by EUS-CYA reduced rebleeding rate and improved variceal bleeding-free survival in patients with inoperable HCC and variceal bleeding when compared with no SP. Randomized studies are needed to confirm the benefits of EUS-CYA for this difficult-to-treat population.

Cholangioscopy-guided lithotripsy for difficult bile duct stone clearance in a single session of ERCP: results from a large multinational registry demonstrate high success rates.

BACKGROUND: Peroral cholangioscopy (POCS) can be useful for difficult bile duct stone clearance. Large prospective multinational data on POCS-guided lithotripsy for clearing difficult bile duct stones in a single session of endoscopic retrograde cholangiopancreatography (ERCP) are missing. METHODS: Patients with difficult bile duct stones (defined as one or more of: largest stone diameter ≥ 15 mm, failed prior attempt at stone clearance, impacted, multiple, hepatic duct location, or located above a stricture) were enrolled at 17 centers in 10 countries. The principal endpoint was stone clearance in a single ERCP procedure using POCS. RESULTS : 156 patients underwent 174 sessions of POCS-guided electrohydraulic or laser lithotripsy. Stone clearance had failed in a previous ERCP using traditional techniques in 124/156 patients (80 %), while 32 /156 patients (21 %) were referred directly to POCS-guided therapy based on preprocedural assessment of the difficulty of stone clearance. In 101/156 patients (65 %), there were impacted stones. POCS-guided stone clearance was achieved in a single POCS procedure in 125 /156 patients (80 %, 95 % confidence interval [CI] 73 % - 86 %), and was significantly more likely for stones ≤ 30 mm compared with > 30 mm (odds ratio 7.9, 95 %CI 2.4 - 26.2; P = 0.002). Serious adverse events occurred in 3/156 patients (1.9 %, 95 %CI 0.4 % - 5.5 %), and included pancreatitis, perforation due to laser lithotripsy, and cholangitis (n = 1 each), all resolved within 1 week. CONCLUSION: POCS-guided lithotripsy is highly effective for clearance of difficult bile duct stones in a single procedure and successfully salvages most prior treatment failures. It may also be considered first-line therapy for patients with difficult choledocholithiasis to avoid serial procedures.

Consensus guidelines on the optimal management in interventional EUS procedures: results from the Asian EUS group RAND/UCLA expert panel.

OBJECTIVES: Interventional endoscopic ultrasonography (EUS) procedures are gaining popularity and the most commonly performed procedures include EUS-guided drainage of pancreatic pseudocyst, EUS-guided biliary drainage, EUS-guided pancreatic duct drainage and EUS-guided celiac plexus ablation. The aim of this paper is to formulate a set of practice guidelines addressing various aspects of the above procedures. METHODS: Formulation of the guidelines was based on the best scientific evidence available. The RAND/UCLA appropriateness methodology (RAM) was used. Panellists recruited comprised experts in surgery, interventional EUS, interventional radiology and oncology from 11 countries. Between June 2014 and October 2016, the panellists met in meetings to discuss and vote on the clinical scenarios for each of the interventional EUS procedures in question. RESULTS: A total of 15 statements on EUS-guided drainage of pancreatic pseudocyst, 15 statements on EUS-guided biliary drainage, 12 statements on EUS-guided pancreatic duct drainage and 14 statements on EUS-guided celiac plexus ablation were formulated. The statements addressed the indications for the procedures, technical aspects, pre- and post-procedural management, management of complications, and competency and training in the procedures. All statements except one were found to be appropriate. Randomised studies to address clinical questions in a number of aspects of the procedures are urgently required. CONCLUSIONS: The current guidelines on interventional EUS procedures are the first published by an endoscopic society. These guidelines provide an in-depth review of the current evidence and standardise the management of the procedures.

Similar Efficacy of Proton-Pump Inhibitors vs H2-Receptor Antagonists in Reducing Risk of Upper Gastrointestinal Bleeding or Ulcers in High-Risk Users of Low-Dose Aspirin.

BACKGROUND & AIMS: It is not clear whether H2-receptor antagonists (H2RAs) reduce the risk of gastrointestinal (GI) bleeding in aspirin users at high risk. We performed a double-blind randomized trial to compare the effects of a proton pump inhibitor (PPI) vs a H2RA antagonist in preventing recurrent upper GI bleeding and ulcers in high-risk aspirin users. METHODS: We studied 270 users of low-dose aspirin (≤325 mg/day) with a history of endoscopically confirmed ulcer bleeding at 8 sites in Hong Kong and Japan. After healing of ulcers, subjects with negative results from tests for Helicobacter pylori resumed aspirin (80 mg) daily and were assigned randomly to groups given a once-daily PPI (rabeprazole, 20 mg; n = 138) or H2RA (famotidine, 40 mg; n = 132) for up to 12 months. Subjects were evaluated every 2 months; endoscopy was repeated if they developed symptoms of upper GI bleeding or had a reduction in hemoglobin level greater than 2 g/dL and after 12 months of follow-up evaluation. The adequacy of upper GI protection was assessed by end points of recurrent upper GI bleeding and a composite of recurrent upper GI bleeding or recurrent endoscopic ulcers at month 12. RESULTS: During the 12-month study period, upper GI bleeding recurred in 1 patient receiving rabeprazole (0.7%; 95% confidence interval [CI], 0.1%-5.1%) and in 4 patients receiving famotidine (3.1%; 95% CI, 1.2%-8.1%) (P = .16). The composite end point of recurrent bleeding or endoscopic ulcers at month 12 was reached by 9 patients receiving rabeprazole (7.9%; 95% CI, 4.2%-14.7%) and 13 patients receiving famotidine (12.4%; 95% CI, 7.4%-20.4%) (P = .26). CONCLUSIONS: In a randomized controlled trial of users of low-dose aspirin at risk for recurrent GI bleeding, a slightly lower proportion of patients receiving a PPI along with aspirin developed recurrent bleeding or ulcer than of patients receiving an H2RA with the aspirin, although this difference was not statistically significant. ClincialTrials.gov no: NCT01408186.