Endoscopic Gallbladder Stenting to Prevent Recurrent Cholecystitis in Deferred Cholecystectomy: A Randomized Trial.

BACKGROUND & AIMS: Endoscopic transpapillary gallbladder stenting (ETGS) has been proposed as one of the adjunctive treatments, apart from antibiotics, before surgery in patients with acute cholecystitis whose cholecystectomy could not be performed or was deferred. Currently, there are no comparative data on the outcomes of ETGS in those who receive and do not receive ETGS. We aimed to compare the rates of recurrent cholecystitis at 3 and 6 months in these 2 groups. METHODS: Between 2020 and 2023, eligible acute calculous cholecystitis patients with a high probability of common bile duct stone, who were surgical candidates but could not have an early cholecystectomy during COVID-19 surgical lockdown, were randomized into groups A (received ETGS) and B (did not receive ETGS). A definitive cholecystectomy was performed at 3 months or later in both groups. RESULTS: A total of 120 eligible patients were randomized into group A (n = 60) and group B (n = 60). In group A, technical and clinical success rates were 90% (54 of 60) and 100% (54 of 54), respectively. Based on intention-to-treat analysis, group A had a significantly lower rate of recurrence than group B at 3 months (0% [0 of 60] vs 18.3% [11 of 60]; P = .001). At 3-6 months, group A showed a nonsignificantly lower rate of recurrent cholecystitis compared to group B (0% [0 of 32] vs 10% [3 of 30]; P = .11). CONCLUSIONS: ETGS could prevent recurrent cholecystitis in acute cholecystitis patients with common bile duct stone whose cholecystectomy was deferred for 3 months. In those who did not receive ETGS, the majority of recurrences occurred within 3 months. (Thaiclinicaltrials.org, Number TCTR20200913001).

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).

Improvement of adenoma detection rate by two computer-aided colonic polyp detection systems in high adenoma detectors: a randomized multicenter trial.

BACKGROUND: This study aimed to evaluate the benefits of a self-developed computer-aided polyp detection system (SD-CADe) and a commercial system (CM-CADe) for high adenoma detectors compared with white-light endoscopy (WLE) as a control. METHODS: Average-risk 50-75-year-old individuals who underwent screening colonoscopy at five referral centers were randomized to SD-CADe, CM-CADe, or WLE groups (1:1:1 ratio). Trainees and staff with an adenoma detection rate (ADR) of ≥35% were recruited. The primary outcome was ADR. Secondary outcomes were the proximal adenoma detection rate (pADR), advanced adenoma detection rate (AADR), and the number of adenomas, proximal adenomas, and advanced adenomas per colonoscopy (APC, pAPC, and AAPC, respectively). RESULTS: The study enrolled 1200 participants. The ADR in the control, CM-CADe, and SD-CADe groups was 38.3%, 50.0%, and 54.8%, respectively. The pADR was 23.0%, 32.3%, and 38.8%, respectively. AADR was 6.0%, 10.3%, and 9.5%, respectively. After adjustment, the ADR and pADR in both intervention groups were significantly higher than in controls (all P<0.05). The APC in the control, CM-CADe, and SD-CADe groups was 0.66, 1.04, and 1.16, respectively. The pAPC was 0.33, 0.53, and 0.64, respectively, and the AAPC was 0.07, 0.12, and 0.10, respectively. Both CADe systems showed significantly higher APC and pAPC than WLE. AADR and AAPC were improved in both CADe groups versus control, although the differences were not statistically significant. CONCLUSION: Even in high adenoma detectors, CADe significantly improved ADR and APC. The AADR tended to be higher with both systems, and this may enhance colorectal cancer prevention.

Sessile serrated lesion prevalence and factors associated with their detection: a post-hoc analysis of a multinational randomized controlled trial from Asia.

BACKGROUND: Sessile serrated lesions (SSLs) are associated with an increased risk of colorectal cancer. Data on the prevalence of SSLs in Asia are limited. We performed this study to estimate the prevalence of SSLs in Asia and to explore endoscopic factors that are associated with SSL detection. METHODS: This is a post-hoc analysis of a multicenter randomized controlled trial from four Asian countries/regions that compared adenoma detection rates using linked-color imaging (LCI) and white-light imaging. Colonoscopies were performed in an average-risk population for screening, diagnostic examination, or polyp surveillance. Patients with SSLs were compared against those without SSLs to evaluate for possible predictors of SSL detection using Firth's logistic regression. RESULTS: 2898 participants (mean age 64.5 years) were included in the analysis. The estimated prevalence of SSLs was 4.0% (95%CI 3.4%-4.8%), with no sex or age group differences. On multivariable analysis, use of LCI (adjusted odds ratio [aOR] 1.63, 95%CI 1.10-2.41), experienced endoscopists (aOR 1.94, 95%CI 1.25-3.00), use of transparent cap (aOR 1.75, 95%CI 1.09-2.81), and longer withdrawal time (aOR 1.06, 95%CI 1.03-1.10) were independently associated with SSL detection. Synchronous adenoma detection (aOR 1.89, 95%CI 1.20-2.99) was also predictive of SSL detection. CONCLUSION: The prevalence of SSLs in Asia is 4.0%. Use of LCI or a transparent cap, greater endoscopist experience, and longer withdrawal time were all associated with increased SSL detection.

Linked color imaging improves colorectal lesion detection especially for low performance endoscopists: An international trial in Asia.

BACKGROUND AND AIM: Linked color imaging (LCI) is an image-enhanced endoscopy technique that accentuates the color difference between red and white, potentially improving the adenoma detection rate (ADR). However, it remains unclear whether LCI performance in detecting colorectal lesions differs based on endoscopists' experience levels. We aimed to evaluate the differences in LCI efficacy based on the experience levels of endoscopists by conducting an exploratory analysis. METHODS: In this post hoc analysis of an international randomized controlled trial comparing the detection of adenoma and other lesions using colonoscopy with LCI and high-definition white light imaging (WLI), we included patients from 11 institutions across four countries/regions: Japan, Thailand, Taiwan, and Singapore. We retrospectively reviewed differences in the lesion detection of LCI according to endoscopists' colonoscopy history or ADR. RESULTS: We included 1692 and 1138 patients who underwent colonoscopies performed by 54 experts (experience of ≥ 5000 colonoscopies) and by 43 non-experts (experience of < 5000 colonoscopies), respectively. Both expert and non-expert groups showed a significant improvement in ADR with LCI compared to WLI (expert, 61.7% vs 46.4%; P < 0.001; non-expert, 56.6% vs 46.4%; P < 0.001). LCI had no effect on sessile serrated lesion detection rate in non-experts (3.1% vs 2.5%; P = 0.518). LCI significantly improved detection rates in endoscopists with relatively low detection performance, defined as an ADR < 50%. CONCLUSIONS: This exploratory study analyzed data from a previous trial and revealed that LCI is useful for both experts and non-experts and is even more beneficial for endoscopists with relatively low detection performance using WLI.

Analysis of the Characteristics of Coexisting Lesions in Colorectal Cancer Patients in an International Study: A Subgroup Analysis of the ATLAS Trial.

INTRODUCTION: We investigated coexisting lesion types in patients with invasive colorectal cancer (CRC) in a multinational study for comprehending the adenoma-carcinoma and serrated pathway about the development of CRC. METHODS: We retrospectively reviewed 3,050 patients enrolled in the international randomized controlled trial (ATLAS study) to evaluate the colorectal polyp detection performance of image-enhanced endoscopy in 11 institutions in four Asian countries/regions. In the current study, as a subgroup analysis of the ATLAS study, 92 CRC patients were extracted and compared to 2,958 patients without CRC to examine the effects of age, sex, and coexisting lesion types (high-grade adenoma [HGA], low-grade adenoma with villous component [LGAV], 10 adenomas, adenoma ≥10 mm, sessile serrated lesions [SSLs], and SSLs with dysplasia [SSLD]). Additional analyses of coexisting lesion types were performed according to sex and location of CRC (right- or left-sided). RESULTS: A multivariate analysis showed that HGA (odds ratio [95% confidence interval] 4.29 [2.16-8.18]; p < 0.01), LGAV (3.02 [1.16-7.83], p = 0.02), and age (1.04 [1.01-1.06], p = 0.01) were independently associated with CRC. According to sex, the coexisting lesion types significantly associated with CRC were LGAV (5.58 [1.94-16.0], p < 0.01) and HGA (4.46 [1.95-10.20], p < 0.01) in males and HGA (4.82 [1.47-15.80], p < 0.01) in females. Regarding the location of CRC, SSLD (21.9 [1.31-365.0], p = 0.03) was significant for right-sided CRC, and HGA (5.22 [2.39-11.4], p < 0.01) and LGAV (3.46 [1.13-10.6], p = 0.02) were significant for left-sided CRC. CONCLUSIONS: The significant coexisting lesions in CRC differed according to sex and location. These findings may contribute to comprehending the pathogenesis of CRC.

Efficacy of multi-hole self-expandable metal stent compared to fully covered and uncovered self-expandable metal stents in patients with unresectable malignant distal biliary obstruction: a propensity analysis.

BACKGROUND AND AIMS: Self-expandable metal stent (SEMS) insertion is the standard palliative treatment for unresectable malignant extrahepatic biliary obstruction (MBO). Drawbacks of conventional fully covered SEMS (FCSEMS) and uncovered SEMS (USEMS) include stent migration and tumor ingrowth, respectively. This study aimed to compare stent patency in MBO with the newly design multi-hole SEMS (MHSEMS), which has multiple small side holes in the stent membrane, with conventional FCSEMS and UCSEMS. PATIENTS AND METHODS: This retrospective study using a propensity score matching design and stent patency times of 40 patients with MHSEMS was compared to 40 and 34 patients with FCSEMS and UCSEMS during the same period, respectively. Secondary outcomes were procedure-related adverse events, clinical success rate, time to recurrent biliary obstruction (RBO), and etiology of RBO. RBO was compared using Kaplan-Meier analysis. RESULTS: Baseline characteristics after matching were comparable among the 3 groups. RBO rates were 21%, 37%, and 55% for MHSEMS, FCSEMS, and UCSEMS, respectively (p = 0.014), at a mean time of 479, 353, and 306 days, respectively (MHSEMS vs UCSEMS, p = 0.002). Rate of tumor ingrowth was highest in the UCSEMS group (42.4% vs 13.2% in MHSEMS; p = 0.005 and vs 0% in FCSEMS; p < 0.001). Stent migration rate was highest in the FCSEMS group at 15.8% vs 2.6% in MHSEMS (p = 0.047) and 0% in UCSEMS (p = 0.005). CONCLUSION: MHSEMS provided the longest stent patency time with lowest RBO rate compared to conventional SEMS by showing a lower stent migration rate than FCSEMS and a lower tumor ingrowth rate than UCSEMS.

Preferential and persistent impact of acute HIV-1 infection on CD4+ iNKT cells in colonic mucosa.

Acute HIV-1 infection (AHI) results in the widespread depletion of CD4+ T cells in peripheral blood and gut mucosal tissue. However, the impact on the predominantly CD4+ immunoregulatory invariant natural killer T (iNKT) cells during AHI remains unknown. Here, iNKT cells from peripheral blood and colonic mucosa were investigated during treated and untreated AHI. iNKT cells in blood were activated and rapidly depleted in untreated AHI. At the time of peak HIV-1 viral load, these cells showed the elevated expression of cell death-associated transcripts compared to preinfection. Residual peripheral iNKT cells suffered a diminished responsiveness to in vitro stimulation early into chronic infection. Additionally, HIV-1 DNA, as well as spliced and unspliced viral RNA, were detected in iNKT cells isolated from blood, indicating the active infection of these cells in vivo. The loss of iNKT cells occurred from Fiebig stage III in the colonic mucosa, and these cells were not restored to normal levels after initiation of ART during AHI. CD4+ iNKT cells were depleted faster and more profoundly than conventional CD4+ T cells, and the preferential infection of CD4+ iNKT cells over conventional CD4+ T cells was confirmed by in vitro infection experiments. In vitro data also provided evidence of latent infection in iNKT cells. Strikingly, preinfection levels of peripheral blood CD4+ iNKT cells correlated directly with the peak HIV-1 load. These findings support a model in which iNKT cells are early targets for HIV-1 infection, driving their rapid loss from circulation and colonic mucosa.

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.

Linked-Color Imaging Detects More Colorectal Adenoma and Serrated Lesions: An International Randomized Controlled Trial.

BACKGROUND & AIMS: Effects of linked-color imaging (LCI) on colorectal lesion detection and colonoscopy quality remain controversial. This study compared the detection rates of adenoma and other precursor lesions using LCI vs white-light imaging (WLI) during screening, diagnostic, and surveillance colonoscopies. METHODS: This randomized controlled trial was performed at 11 institutions in 4 Asian countries/regions. Patients with abdominal symptoms, a primary screening colonoscopy, positive fecal immunochemical test results, or undergoing postpolypectomy surveillance were recruited and randomly assigned in a 1:1 ratio to either the LCI or high-definition WLI group. The primary outcome was adenoma detection rate (ADR). Secondary outcomes were polyp detection rate, advanced ADR, sessile serrated lesion (SSL) detection rate, and the mean number of adenomas per colonoscopy. The recommended surveillance schedule distribution after trial colonoscopy was analyzed. RESULTS: Between November 2020 and January 2022, there were 3050 participants (LCI, n = 1527; WLI, n = 1523) recruited. The LCI group ADR was significantly higher than the WLI group ADR using intention-to-treat (58.7% vs 46.7%; P < .01) and per-protocol analyses (59.6% vs 46.4%; P < .01). The LCI group polyp detection rates (68.6% vs 59.5%; P < .01), SSL detection rates (4.8% vs 2.8%; P < .01), and adenomas per colonoscopy (1.48 vs 1.02; P < .01) also were significantly higher. However, the advanced ADR was not significantly different (13.2% vs 11.0%; P = .06). Significantly more patients in the LCI group had shorter recommended surveillance schedules than the WLI group (P < .01). CONCLUSIONS: Compared with WLI, LCI improved adenoma and other polyp detection rates, including SSLs, resulting in alteration of the recommended surveillance schedule after screening, diagnostic, and postpolypectomy surveillance colonoscopies. TRIAL REGISTRATION NUMBER: UMIN000042432 (https://www.umin.ac.jp/ctr/index.htm).

Computer-aided detection, mucosal exposure device, their combination, and standard colonoscopy for adenoma detection: a randomized controlled trial.

BACKGROUND AND AIMS: Computer-aided detection (CADe) and a mucosal exposure device can improve adenoma detection rate (ADR). Potential benefits of combining the 2 modalities have never been studied. This study aimed to compare ADR differences among CADe alone, endocuff-assisted colonoscopy (EAC) alone, and the combination of CADe and EAC (CADe+EAC) with standard colonoscopy. METHODS: This prospective randomized controlled study included 1245 participants who underwent screening colonoscopy. Participants were randomized to CADe, EAC, CADe+EAC, and standard colonoscopy as a control. The primary outcome was ADR. Secondary outcomes were proximal ADR (pADR), advanced ADR (AADR), and the number of adenomas per colonoscopy (APCs). RESULTS: ADRs from the control, CADe, EAC, and CADe+EAC groups were 41.9%, 52.2%, 54.0%, and 58.8%, respectively; pADRs were 25.2%, 33.3%, 34.9%, and 37.0%, respectively; AADRs were 7.7%, 8.3%, 8.3%, and 13.6%, respectively; and APCs were .76, 1.11, 1.18, and 1.31, respectively. Significant increases in ADR and pADR were observed between the intervention and control groups (P < .05 in all comparisons). The AADR was significantly higher only in the CADe+EAC group than in the control group (P = .02). The adjusted incidence rate ratios of APCs were significantly higher in the intervention groups versus the control group (P < .01 in all comparisons). CONCLUSIONS: CADe+EAC significantly improve ADR and AADR over standard colonoscopy. However, although CADe or EAC alone can substantially increase the detection of adenomas, they do not lead to increased detection of advanced adenomas unless used in combination. (Clinical trial registration number: TCTR20200929003.).

Intermediate- to long-term outcomes of endoscopic transpapillary gallbladder stenting in patients with gallstone-related disease: a 10-year single-center experience.

BACKGROUND: Endoscopic transpapillary gallbladder stenting (ETGS) can be a bridging therapy to elective cholecystectomy or a permanent gallbladder drainage method in patients with symptomatic gallbladder disease who are awaiting cholecystectomy or are unfit for surgery, respectively. We evaluated the intermediate- to long-term outcomes of ETGS in these groups. METHODS: We retrospectively reviewed 234 patients (acute cholecystitis = 147), who were unfit for surgery (n = 50) or had deferred cholecystectomy (n = 184) and who underwent ETGS between 2012 and 2021. A 7-Fr, 15-cm, double-pigtail plastic stent was placed for ETGS without scheduled stent exchange. Biliary event-free rates (i. e. cholecystitis and cholangitis) were determined at 6 months, 1 year, and ≥ 2 years. RESULTS: Technical and clinical success rates were 84.6 % (198/234) and 97.4 % (193/198), respectively. Kaplan-Meier analysis (n = 193) showed a biliary event-free rate of 99 % (95 %CI 0.95-1.00) at 6 months, 92 % (95 %CI 0.87-0.97) at 1 year, and 76 % (95 %CI 0.65-0.93) at ≥ 2 years, during a median follow-up period of 564 days (range 200-3001 days). CONCLUSIONS: ETGS is an effective biliary drainage method that should be considered in selected cases with common bile duct stone where cholecystectomy could not be performed or was deferred. The biliary event-free rates of ≥ 76 % up to ≥ 2 years further support the use of ETGS in these patient groups.

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.

Morphology of the major duodenal papilla for the selection of advanced cannulation techniques in difficult biliary cannulation.

BACKGROUND: Morphology of the major duodenal papilla (MDP) influences the outcome of standard biliary cannulation. However, those data on advanced cannulation techniques are scarce. We aimed to study the impact of MDP morphology on the outcome of both standard and advanced cannulation methods. METHODS: Images of naïve papilla were retrospectively reviewed and independently classified into 4 types (1: classic appearance, 2: small, 3: bulging, and 4: ridged papillae). All cannulation was started with guidewire cannulation. After failure, advanced cannulation including double guidewire (DG) and/or precut sphincterotomy (PS) was performed. Outcomes including success rate and complications were analyzed. RESULTS: A total 805 naïve papilla were included. The overall advanced cannulation rate was 23.2%. The MPD type 2 (OR 1.8, 95% CI 1.8-2.9) and type 4 (OR 2.1, 95% CI 1.1-3.8) required advanced cannulation technique at a higher rate than type 1. Type 3 significantly needed a higher proportion of PS when compared with type 1 (59.09% vs 27.03%, OR 3.90, 95% CI 1.51-10.06). Overall post-ERCP pancreatitis (PEP) was 8% and was not different among MDP types. PEP was significantly increased in difficult cannulation group (15.38% vs 5.71%, p-value < 0.001). Multivariate analysis demonstrated that DG independently increased risk of PEP (OR 3.6, 95% CI 2.0-6.6). CONCLUSIONS: MDP type 2 and type 4 were related to difficult cannulation. Although DG and PS can be used as advanced cannulation in all types, DG carries risk of PEP and PS may be preferred over DG in MDP type 3.

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.

Bacterial contamination and organic residue after reprocessing in duodenoscopes with disposable distal caps compared with duodenoscopes with fixed distal caps: a randomized trial.

BACKGROUND AND AIMS: Newly designed duodenoscopes with disposable distal caps have been developed for better cleaning and preprocessing to reduce the risk of bacterial contamination (BC). We compared BC and organic residue of duodenoscopes with disposable distal caps and duodenoscopes with fixed distal caps after manual cleaning and high-level disinfection (HLD). METHODS: Four hundred duodenoscopes were randomized into group A (fixed distal caps, n = 200) and group B (disposable distal caps, n = 200). After manual cleaning, samples from the elevator were submitted for culture. An adenosine triphosphate (ATP) test was performed for organic residue evaluation. Based on our previous data, ATP < 40 relative light units (RLUs) had 100% sensitivity with 100% negative predictive value to confirm no BC after reprocessing. RESULTS: After manual cleaning, group A had a higher BC rate (14% vs 7%, P = .02), a higher proportion of duodenoscopes with ATP ≥ 40 RLUs (73.5% vs 57%, P = .001), and a higher mean of ATP level (226.6 vs 82.0 RLUs, P < .001) compared with group B. After HLD, the proportion of potential BC (ATP ≥ 40 RLUs) in group A was 2.7 times higher than group B (4% vs 1.5%, P = .13). Mean ATP level after HLD in the 2 groups was significantly lower than before the HLD procedure (group A, 24.2 vs 226.6 RLUs [P < .001]; group B, 20.4 vs 82.0 RLUs [P < .001], respectively). CONCLUSIONS: After manual cleaning, duodenoscopes with disposable distal caps had significantly lower BC and organic residue than duodenoscopes with fixed distal caps. Only a few duodenoscopes from each group did not pass the ATP threshold after HLD.

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.

A comparison of the antegrade core trap and reverse bevel needles for EUS-guided fine-needle biopsy sampling of liver mass: a prospective randomized cross over study.

BACKGROUND: Data on the use of EUS-guided fine-needle biopsy (EUS-FNB) of solid liver mass (SLM) for pathology is limited. METHODS: To prove superiority of the diagnostic rate of the newly designed modified Menghini-type needle with a beveled side-slot near the needle tip with slot cutting edge directed 20-gauge antegrade bevel (group A) over the original 22-gauge reverse bevel (group B) for EUS-guided fine-needle biopsy (EUS-FNB) of solid liver mass (SLM) in a prospective crossover randomized controlled trial. RESULTS: The overall diagnostic accuracy rate of the 52 passes was 86.5% (45/52) and of group A versus B were 88.5% (23/26) versus 84.6% (22/26), respectively, p = 0.858. Tissue adequacy levels of both groups were not significantly different (grade A: B: C = 18:6:2 versus 16:7:3), p = 0.839). Grading of blood contamination of both groups was not significantly different. However, it was found that the group-A needles could biopsy tissue of significantly longer length than that of the group B; 1.3 cm (SD = 0.76) versus 0.8 cm (SD = 0.54); p = 0.007. CONCLUSION: The use of EUS-FNB of SLM is highly effective with similar levels of efficacy and number of adverse events between both types of needles. THE TRIAL REGISTRATION NUMBER: Thai Clinical Trial Registration No. TCTR2018081002.