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).

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.).

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.

Temporal trend in the natural history of ulcerative colitis in a country with a low incidence of ulcerative colitis from 2000 through 2018.

BACKGROUND/AIMS: The incidence of ulcerative colitis (UC) in Thailand (crude incidence rate of 0.28 per 100,000 persons) is much lower than in the West. The burden of UC varies in different populations. The aim of this study was to evaluate the natural history of UC over the two decades in Bangkok, Thailand. METHODS: This retrospective study included patients who were diagnosed with UC between 2000 and 2018 in 2 university hospitals. To evaluate changes in the disease course, we stratified patients into 2000-2009 cohort and 2010-2018 cohort. The cumulative probability of endoscopic healing, UC-related hospitalization and colectomy was estimated using the Kaplan-Meier method. RESULTS: A total of 291 UC patients were followed for total of 2,228 person-years. Comparison between 2 cohorts, there were no differences in disease pattern and severity whereas an increase in the combination use of oral and topical mesalamine and the early use of thiopurine was observed. Only 1% of patients for each cohort required biologic agent at 5 years. The rate of achieving mucosal healing increased from 15% to 46% at 3 years (P< 0.01). The rate of UC-related hospitalization decreased from 30% to 21% at 5 years (P< 0.05). The rate of colectomy decreased from 6% to 2% at 5 years (P< 0.05). CONCLUSIONS: The natural history of UC in a low incidence country was less aggressive than the West. Over the past two decades, the rates of UC-related hospitalization and colectomy have been decreasing which were similar to the West.

Burden of Inflammatory Bowel Disease on Patient Mood, Fatigue, Work, and Health-Related Quality of Life in Thailand: A Case-Control Study.

Background: Inflammatory bowel disease (IBD) has become an emerging disease in Asia. The burden of disease affects health-related quality of life (HRQoL), economics, and society. We compared HRQoL of IBD patients with/without active disease to that of the general population. Methods: Consecutive patients with active disease and patients in clinical remission were prospectively recruited. For each IBD patient, an age- and sex-matched healthy control was invited. Active disease was defined as patient-reported clinical symptoms (ClinPRO) with endoscopic inflammation. All participants completed five questionnaires: (1) Short IBD Questionnaire (SIBDQ); (2) Hospital Anxiety and Depression Scale (HADS); (3) Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue); (4) Work Productivity and Activity Impairment questionnaire (WPAI); and (5) EuroQol 5-Dimension 5-Level scale (EQ5D5L). Multiple regression analyses were used to assess differences in HRQoL scores between IBD patients and controls. Results: A total of 418 participants (209 IBD, 209 controls) were included. There were 101 patients with active disease and 108 patients in clinical remission. Regarding patients with active disease compared with controls, there was a significant mean difference in scores (95% CI) of 12.3 (9.5-15.2) on the SIBDQ; 6.7 (4.7-8.8), FACIT-fatigue; 1.6 (0.6-2.7), HADS-anxiety; 1.6 (0.8-2.4), HADS-depression; 20.3% (13.0%-27.7%), work productivity impairment; and 0.089 (0.045-0.134), EQ5Q5L (P < .05, all comparisons). Regarding patients in clinical remission compared with controls, none of these mean differences achieved a minimal clinically important difference. Conclusions: Active IBD has a negative impact on HRQoL, whereas patients in clinical remission showed no clinically significant difference from the general population on HRQoL.

Overweight as an Additional Risk Factor for Colorectal Neoplasia in Lean Population

Background: Overweight in Thailand is not as common as in Western countries. We sought to evaluate overweight as the additional risk factor that can increase the prediction of colorectal neoplasia (CRN) detection in Thais apart from the Asia-Pacific Colorectal Screening (APCS) score. Methods: We prospectively enrolled asymptomatic 338 subjects who underwent screening colonoscopy between November 2016 and September 2017. All risk factors according to APCS, BMI and the presence of metabolic syndrome were collected. Overweight was defined as BMI ≥23 kg/m2. By APCS score, subjects were categorized into 1) high-risk and 2) average-risk. Using the combination of APCS score and overweight, subjects were stratified into 4 groups; high-risk with overweight (G1), average-risk with overweight (G2), high-risk with normal weight (G3) average-risk and with normal weight (G4). Logistic regression analysis was used to estimate the risk of detecting CRN. Results: The prevalence of CRN in the high-risk subjects was higher than that of in the average-risk subjects (49%vs.32%; OR, 2.00; 95%CI, 1.17-3.41). After adjustment for APCS risk factors and metabolic syndrome, overweight significantly increased the risk of detecting CRN (OR, 2.52; 95%CI, 1.57-4.05). Among the 4 groups, the detection rates of CRN were significantly different (G1=64%, G2=40%, G3=32% and G4=21%, p<0.01). The relative risk of detecting CRN increased when G1 (OR 6.49; 95%CI, 2.87-14.67), and G2 (2.42; 1.39-4.21) were compared with G4. Conclusions: In addition to the APCS score, overweight is an independent risk factor for detecting CRN. In Thai population, combining overweight and APCS score may be useful to improve the prediction for CRN.