Assessment, Resuscitation and Medical Management of Variceal and Nonvariceal Gastrointestinal Bleeding.

Upper gastrointestinal bleeding (UGIB) continues to be an important cause for emergency room visits and carries significant morbidity and mortality. Early resuscitative measures form the basis of the management of patients presenting with UGIB and can improve the outcomes of such patients including lowering mortality. In this review, using an evidence-based approach, we discuss the initial assessment and resuscitation of patients presenting with UGIB including identifying clues from history and physical examination to confirm UGIB, preendoscopic risk assessment tools, the role of early fluid resuscitation, utilization of blood products, use of pharmacologic interventions, and the optimal timing of endoscopy.

Primary and Specialty Care Trainees' Perceptions About Proton Pump Inhibitor Use.

OBJECTIVE: Proton pump inhibitors (PPIs) are widely prescribed with proven efficacy in many indications, yet longstanding controversy about potential adverse events persists. We aimed to acquire knowledge about perceptions of outpatient PPI long-term prescribing (≥8 wk) among primary and specialty care trainees at 2 Canadian Universities. METHODS: Family medicine, internal medicine, and gastroenterology trainees completed a web-based survey that included 20 clinical scenarios assessing trainee knowledge about PPI efficacy. Contextual PPI prescribing decisions were also elicited, balancing possible PPI indications versus side effects. Management strategies were compared between junior and senior trainees, as well as across training programs. RESULTS: Over a 4-month period,163 trainees (age <26 y: 12%; age 26 to 45: 88%; 59% females) participated in the survey (family medicine: 51%, internal medicine: 44%, and gastroenterology: 5%); 83% were considered junior residents. Only 42% had received formal education on prescribing PPI long-term. Overall, 93% believed they would benefit from such teaching, with 98% stating they would follow related guidelines. No between-group differences were noted in knowledge of appropriate PPI indications nor possible side effects when comparing juniors to seniors, or among different specialties. Across different management scenarios, inappropriate PPI discontinuation was chosen by 14.3% to 67.2%, whereas inappropriate PPI continuation was reported in up to 57%. Trainee seniority and specialty did not differ in appropriate deprescribing rates. CONCLUSIONS: Training level and primary versus specialty care settings are associated with frequent inappropriate PPI prescribing and deprescribing. These findings highlight the need for and may inform future educational programs on PPI usage.

Review article: Advances in the management of lower gastrointestinal bleeding.

BACKGROUND: Lower gastrointestinal bleeding (LGIB) is a common emergency with substantial associated morbidity and mortality. Elective colonoscopy plays an essential role in management, with an even more important role for radiology in the acute setting. Recent advances in the management of patients with LGIB warrant review as the management has recently evolved. AIMS: To provide a comprehensive and updated overview of advances in the approach to patients with LGIB METHODS: We performed a comprehensive literature search to examine the current data for this narrative review supplemented by expert opinion. RESULTS: The incidence of LGIB is increasing worldwide, partly related to an ageing population and the increasing use of antithrombotics. Diverticulosis continues to be the most common aetiology of LGIB. Pre-endoscopic risk stratification tools, especially the Oakland score, can aid appropriate patient triage. Adequate resuscitation continues to form the basis of management, while appropriate management of antithrombotics is crucial to balance the risk of worsening bleeding against increased cardiovascular risk. Radiological imaging plays an essential role in the diagnosis and treatment of acute LGIB, especially among unstable patients. Colonoscopy remains the gold-standard test for the elective management of stable patients. CONCLUSIONS: The management of LGIB has evolved significantly in recent years, with a shift towards radiological interventions for unstable patients while reserving elective colonoscopy for stable patients. A multidisciplinary approach is essential to optimise the outcomes of patients with LGIB.

The impact of nonalcoholic fatty liver disease on inflammatory bowel disease-related hospitalization outcomes: a systematic review.

Evidence suggests that patients with inflammatory bowel disease are at higher risk of developing nonalcoholic fatty liver disease (NAFLD). However, there is limited information currently available on how NAFLD may affect the clinical course of IBD. Thus, we conducted a systematic review to evaluate the impact of NAFLD on IBD-related hospitalization outcomes. All observational studies assessing IBD-related hospitalization outcomes in patients with NAFLD were included. Exclusion criteria were studies published in languages other than English or French, or those involving pediatric population. Outcomes included IBD-related hospitalization and readmission rates, need for surgery, length of stay, inpatient mortality, and costs. Overall, 3252 citations were retrieved and seven studies met the inclusion criteria (1 574 937 patients); all were observational, of high quality, and originated in the United States. Measurable outcomes reported in these studies were few and with insufficient similarity across studies to complete a quantitative assessment. Only one study reports NAFLD severity. Two studies suggested a higher rate of hospitalization for patients with both NAFLD and IBD compared to IBD alone (incidence rate ratio of 1.54; 95% confidence interval: 1.33-1.79). This is the first systematic review to date that evaluates any possible association of NAFLD with IBD-related hospitalization outcomes. Despite the paucity and low quality of available data, our findings indicate that NAFLD may be associated with worse outcomes amongst IBD patients (especially Crohn's disease). Further and higher certainty of evidence is needed for better characterization of such clinical impact.

Pre-Endoscopic Scores Predicting Low-Risk Patients with Upper Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis.

BACKGROUND: Several risk scores have attempted to risk stratify patients with acute upper gastrointestinal bleeding (UGIB) who are at a lower risk of requiring hospital-based interventions or negative outcomes including death. This systematic review and meta-analysis aimed to compare predictive abilities of pre-endoscopic scores in prognosticating the absence of adverse events in patients with UGIB. METHODS: We searched MEDLINE, EMBASE, Central, and ISI Web of knowledge from inception to February 2023. All fully published studies assessing a pre-endoscopic score in patients with UGIB were included. The primary outcome was a composite score for the need of a hospital-based intervention (endoscopic therapy, surgery, angiography, or blood transfusion). Secondary outcomes included: mortality, rebleeding, or the individual endpoints of the composite outcome. Both proportional and comparative analyses were performed. RESULTS: Thirty-eight studies were included from 2153 citations, (n = 36,215 patients). Few patients with a low Glasgow-Blatchford score (GBS) cutoff (0, ≤1 and ≤2) required hospital-based interventions (0.02 (0.01, 0.05), 0.04 (0.02, 0.09) and 0.03 (0.02, 0.07), respectively). The proportions of patients with clinical Rockall (CRS = 0) and ABC (≤3) scores requiring hospital-based intervention were 0.19 (0.15, 0.24) and 0.69 (0.62, 0.75), respectively. GBS (cutoffs 0, ≤1 and ≤2), CRS (cutoffs 0, ≤1 and ≤2), AIMS65 (cutoffs 0 and ≤1) and ABC (cutoffs ≤1 and ≤3) scores all were associated with few patients (0.01-0.04) dying. The proportion of patients suffering other secondary outcomes varied between scoring systems but, in general, was lowest for the GBS. GBS (using cutoffs 0, ≤1 and ≤2) showed excellent discriminative ability in predicting the need for hospital-based interventions (OR 0.02, (0.00, 0.16), 0.00 (0.00, 0.02) and 0.01 (0.00, 0.01), respectively). A CRS cutoff of 0 was less discriminative. For the other secondary outcomes, discriminative abilities varied between scores but, in general, the GBS (using cutoffs up to 2) was clinically useful for most outcomes. CONCLUSIONS: A GBS cut-off of one or less prognosticated low-risk patients the best. Expanding the GBS cut-off to 2 maintains prognostic accuracy while allowing more patients to be managed safely as outpatients. The evidence is limited by the number, homogeneity, quality, and generalizability of available data and subjectivity of deciding on clinical impact. Additional, comparative and, ideally, interventional studies are needed.

Strengths and limitations of risk stratification tools for patients with upper gastrointestinal bleeding: a narrative review.

INTRODUCTION: Despite advances in the management of patients with upper gastrointestinal bleeding (UGIB), associated morbidity and mortality remain significant. Most patients, however, will experience favorable outcomes without a need for hospital-based interventions. Risk assessment scores may assist in such early risk-stratification. These scales may optimize identification of low-risk patients, resulting in better resource utilization, including a reduced need for early endoscopy and fewer hospital admissions. The aim of this article is to provide an updated detailed review of risk assessment scores in UGIB. AREA COVERED: A literature review identified past and currently available pre-endoscopic risk assessment scores for UGIB, with a focus on low-risk prediction. Strengths and weaknesses of the different scales are discussed as well as their impact on clinical decision-making. EXPERT OPINION: The current evidence supports using the Glasgow Blatchford Score as it is the most accurate tool available when attempting to identify low-risk patients who can be safely managed on an outpatient basis. Currently, no risk assessment tool appears accurate enough in confidently classifying patients as high risk. Future research should utilize more standardized methodologies, while favoring interventional trial designs to better characterize the clinical impact attributable to the use of such risk stratification schemes.

Cost-effectiveness of Artificial Intelligence-Aided Colonoscopy for Adenoma Detection in Colon Cancer Screening.

Background and Aims: Artificial intelligence-aided colonoscopy significantly improves adenoma detection. We assessed the cost-effectiveness of the GI Genius technology, an artificial intelligence-aided computer diagnosis for polyp detection (CADe), in improving colorectal cancer outcomes, adopting a Canadian health care perspective. Methods: A Markov model with 1-year cycles and a lifetime horizon was used to estimate incremental cost-effectiveness ratio comparing CADe to conventional colonoscopy polyp detection amongst patients with a positive faecal immunochemical test. Outcomes were life years (LYs) and quality-adjusted life years (QALY) gained. The analysis applied costs associated with health care resource utilization, including procedures and follow-ups, from a provincial payer's perspective using 2022 Canadian dollars. Effectiveness and cost data were sourced from the literature and publicly available databases. Extensive probabilistic and deterministic sensitivity analyses were performed, assessing model robustness. Results: Life years and QALY gains for the CADe and conventional colonoscopy groups were 19.144 versus 19.125 and 17.137 versus 17.113, respectively. CADe and conventional colonoscopies' overall per-case costs were $2990.74 and $3004.59, respectively. With a willingness-to-pay pre-set at $50,000/QALY, the incremental cost-effectiveness ratio was dominant for both outcomes, showing that CADe colonoscopy is cost-effective. Deterministic sensitivity analysis confirmed that the model was sensitive to the incidence risk ratio of adenoma per colonoscopy for large adenomas. Probabilistic sensitivity analysis showed that the CADe strategy was cost-effective in up to 73.4% of scenarios. Conclusion: The addition of CADe solution to colonoscopy is a dominant, cost-effective strategy when used in faecal immunochemical test-positive patients in a Canadian health care setting.

Topical hemostatic agents in the management of upper gastrointestinal bleeding: a meta-analysis.

Background and study aims Novel topical hemostatic agents have shown promising results in treating patients with non-variceal upper gastrointestinal bleeding (NVUGIB). However, data are limited even in published meta-analyses as to their role, especially compared to conventional endoscopic approaches. The aim of this study was to perform a highly comprehensive systematic review assessing the effectiveness of topical hemostatic agents in UGIB in different clinical settings. Methods We performed a literature search of OVID MEDLINE, EMBASE, and ISI Web of Knowledge databases through September 2021. Studies assessing the efficacy of topical hemostatic agents in UGIB were included. Main outcomes were immediate hemostasis and overall rebleeding. Results A total of 980 citations were identified and 59 studies with a total of 3,417 patients were included in the analysis. Immediate hemostasis was achieved in 93 % (91 %; 94 %), with similar results according to etiology (NVUGIB vs. variceal), topical agent used, or treatment strategy (primary vs. rescue). The overall rebleeding rate was 18 % (15%; 21 %) with the majority of rebleeds occurring in the first 7 days. Among comparative studies, topical agents achieved immediate hemostasis more often than standard endoscopic modalities (OR 3.94 [1.73; 8.96), with non-different overall rebleeding odds (OR 1.06 [0.65; 1.74]). Adverse events occurred in 2 % (1 %; 3 %). Study quality was overall low to very low. Conclusions Topical hemostatic agents are effective and safe in the management of UGIB with favorable outcomes when compared to conventional endoscopic modalities across a variety of bleeding etiologies. This is especially true in novel subgroup analyses that assessed immediate hemostasis and rebleeding among RCTs and in malignant bleeding. Due to methodological limitations of available data, additional studies are needed to ascertain their effectiveness more confidently in the management of patients with UGIB.

Comparative Evaluation of the ABC Score to Other Risk Stratification Scales in Managing High-risk Patients Presenting With Acute Upper Gastrointestinal Bleeding.

OBJECTIVE: The ABC risk score identifies patients at high risk of mortality in acute lower and upper gastrointestinal bleeding (UGIB). We aimed to externally validate the ABC score while comparing it to other prognostication scales when assessing UGIB patients at high risk of negative outcomes before endoscopy. METHODS: UGIB patients from a national Canadian registry (REASON) were studied, with mortality prediction as a primary outcome. Secondary endpoints included prognostication of rebleeding, intensive care unit (ICU) admission, ICU and hospitalization lengths of stay (LOS), and a previously proposed composite outcome measure. Univariable and areas under the receiver operating characteristic curve analyses compared discriminatory abilities of the ABC score to the AIMS65, Glasgow Blatchford Scale (GBS), and clinical Rockall score. RESULTS: The REASON registry included 2020 patients [89.4% nonvariceal; mean age (±SD): 66.3±16.4 y; 38.4% female]. Overall mortality, rebleeding, ICU admission, transfusion and composite score rates were 9.9%, 11.4%, 21.1%, 69.0%, and 67.3%, respectively. ICU and hospitalization LOS were 5.4±9.3 and 9.1±11.5 days, respectively. The ABC score displayed superior 30-day mortality prediction [0.78 (0.73; 0.83)] compared with GBS [0.69 (0.63; 0.75)] or clinical Rockall [0.64 (0.58; 0.70)] but not AIMS65 [0.73 (0.67; 0.79)]. Although most scales significantly prognosticated secondary outcomes in the univariable analysis except for ICU LOS, discriminatory abilities on areas under the receiver operating characteristic curve analyses were poor. CONCLUSIONS: ABC and AIMS65 display similar good prediction of mortality. Clinical usefulness in prognosticating secondary outcomes was modest for all scales, limiting their adoptions when informing early management of high-risk UGIB patients.

Mandatory vs. optional split-dose bowel preparation for morning colonoscopies: a pragmatic noninferiority randomized controlled trial.

BACKGROUND : We compared the effectiveness of optional split-dose bowel preparation (SDBP) with mandatory SDBP for morning colonoscopies in usual clinical practice. METHODS : Adult patients undergoing outpatient early morning (8:00 AM-10:30 PM) and late morning (10:30 AM-12:00 PM) colonoscopies were included. Written bowel preparation instructions were provided based on randomization: one group were instructed to take their bowel preparation (4 L polyethylene glycol solution) as a split dose (mandatory), while the comparator group was allowed the choice of SDBP or single-dose bowel preparation administered entirely on the day before (optional). The primary end point, using noninferiority hypothesis testing with a 5 % margin, was adequate bowel cleanliness measured by the Boston Bowel Preparation Scale (BBPS) and defined by a BBPS score ≥ 6. RESULTS : Among 770 randomized patients with complete data, there were 267 mandatory SDBP and 265 optional SDBP patients for early morning colonoscopies, and 120 mandatory SDBP and 118 optional SDBP patients for late morning colonoscopies. Optional SDBP was inferior to mandatory SDBP, with a lower proportion of adequate BBPS cleanliness for early morning colonoscopies (78.9 % vs. 89.9 %; absolute risk difference [aRD] 11.0 %, 95 %CI 5.9 % to 16.1 %), but was not statistically different for late morning colonoscopies (76.3 % vs. 83.3 %; aRD 7.1 %, 95 %CI -1.5 % to 15.5 %). CONCLUSIONS : Optional SDBP is inferior to mandatory SDBP in providing adequate bowel preparation quality for early morning colonoscopies (8:00 AM-10:30 AM), and probably inferior for late morning colonoscopies (10:30 AM-12:00 PM).

An update on the management of non-variceal upper gastrointestinal bleeding.

Upper gastrointestinal bleeding (UGIB) continues to be a common gastrointestinal emergency that carries significant morbidity and mortality. The epidemiology of UGIB has been changing over the last few decades with an overall decrease in peptic ulcer disease and increase in the prevalence of other etiologies including vascular lesions and malignancy. Appropriate risk assessment and patient stratification are crucial to ensuring that optimal care is delivered to patients and some risk assessment tools have shown excellent ability to define a low-risk group who can be managed as outpatients safely. Regardless of the etiology of UGIB, resuscitative interventions by primary care providers remain the most important initial measures to improve the outcome for patients including hemodynamic stabilization, an appropriate blood transfusion strategy, with or without acid-lowering agents, while also providing subsequent urgent endoscopic assessment and intervention. In addition, with increasing use of antithrombotic agents in clinical practice and its associated risk of bleeding, the management of such agents in the acute setting has become a real challenge to all physicians. In this article, we provide an up-to-date, evidence-based, practical review of recent changes and advances in UGIB with a focus on non-variceal etiologies.

Periprocedural Management of Patients With Atrial Fibrillation Receiving a Direct Oral Anticoagulant Undergoing a Digestive Endoscopy.

INTRODUCTION: The periprocedural management of patients with atrial fibrillation (AF) using a direct oral anticoagulant (DOAC) undergoing elective gastrointestinal (GI) endoscopic procedure remains uncertain. We investigated the safety of a standardized periprocedural DOAC management strategy. METHODS: The Periprocedural Anticoagulation Use for Surgery Evaluation cohort study enrolled adult patients receiving a DOAC (apixaban, rivaroxaban, or dabigatran) for AF scheduled for an elective procedure or surgery. This analysis addresses patients undergoing digestive endoscopy. Standardized periprocedural management consisted of DOAC interruption 1 day preendoscopy with resumption 1 day after procedure at low-moderate risk of bleeding or 2 days in case of a high bleeding risk. Thirty-day outcomes included GI bleeding, thromboembolic events, and mortality. RESULTS: Of 556 patients on a DOAC (mean [SD] age of 72.5 [8.6] years; 37.4% female; mean CHADS 2 score 1.7 [1.0]), 8.6% were also on American Society of Anesthesiology (ASA) and 0.7% on clopidogrel. Most of the patients underwent colonoscopies (63.3%) or gastroscopies (14.0%), with 18.9% having both on the same procedural day. The mean total duration of DOAC interruption was 3.9 ± 1.6 days. Four patients experienced an arterial thromboembolic event (0.7%, 0.3%-1.8%) within 24.2 ± 5.9 days of DOAC interruption. GI bleeding events occurred in 2.5% (1.4%-4.2%) within 11.1 ± 8.1 days (range: 0.6; 25.5 days) of endoscopy, with major GI bleeding in 0.9% (0.4%-2.1%). Three patients died (0.5%; 0.2%-1.6%) 15.6-22.3 days after the endoscopy. DISCUSSION: After a contemporary standardized periprocedural management strategy, patients with AF undergoing DOAC therapy interruption for elective digestive endoscopy experienced low rates of arterial thromboembolism and major bleeding.

An Expert Consensus to Standardize Assessment of Bowel Cleansing for Clinical Trials of Bowel Preparations for Crohn's Disease.

BACKGROUND: Despite regular need for colonoscopy in patients with Crohn's disease (CD), the efficacy and tolerability of bowel preparation (BP) agents is rarely assessed in this population. Assessing BP quality with existing scales may be challenging in CD due to presence of inflammation, bowel resection, and strictures. AIMS: To provide recommendations for assessing BP quality in clinical trials for CD using a modified Research and Development/University of California, Los Angeles appropriateness process. METHODS: Based on systematic reviews and a literature search, 110 statements relating to BP quality assessment in CD were developed. A panel of 15 gastroenterologists rated the statements as appropriate, uncertain, or inappropriate using a 9-point Likert scale. RESULTS: Panelists considered it appropriate that central readers, either alone or with local assessment, score BP quality in clinical trials. Central readers should be trained on scoring BP quality and local endoscopists on performing high-quality video recording. Both endoscope insertion and withdrawal phases should be reviewed to score BP quality in each colonic segment and segments should align with endoscopic disease activity indices. The Harefield Cleansing Scale and the Boston Bowel Preparation Scale were considered appropriate. The final score should be calculated as the average of all visualized segments. Both total and worst segment scores should also be assessed. CONCLUSIONS: We developed a framework for assessing BP quality in patients with CD based on expert feedback. This framework could support the development or refinement of BP quality scales and the integration of BP quality assessment in future CD studies.

Incomplete resection of colorectal polyps of 4-20 mm in size when using a cold snare, and its associated factors.

BACKGROUND : Cold snare polypectomy (CSP) is increasingly used for polypectomy and is recommended as the first-line modality for small (< 10 mm) polyps. This study aimed to evaluate incomplete resection rates (IRRs) when using CSP for colorectal polyps of 4-20 mm. METHODS : Adults (45-80 years) undergoing screening, surveillance, or diagnostic colonoscopy and CSP by one of nine endoscopists were included. The primary outcome was the IRR for colorectal polyps of 4-20 mm, defined as the presence of polyp tissue in marginal biopsies after resection of serrated polyps or adenomas. Secondary outcomes included the IRR for serrated polyps, ease of resection, and complications. RESULTS: 413 patients were included (mean age 63; 48 % women) and 182 polyps sized 4-20 mm were detected and removed by CSP. CSP required conversion to hot snare resection in < 1 % of polyps of < 10 mm and 44 % of polyps sized 10-20 mm. The IRRs for polyps < 10 mm and ≥ 10 mm were 18 % and 21 %. The IRR was higher for serrated polyps (26 %) compared with adenomas (16 %). The IRR was higher for flat (IIa) polyps (odds ratio [OR] 2.9, 95 %CI 1.1-7.4); and when resection was judged as difficult (OR 4.2, 95 %CI 1.5-12.1), piecemeal resection was performed (OR 6.6, 95 %CI 2.0-22.0), or visible residual polyp was present after the initial resection (OR 5.4, 95 %CI 2.0-14.9). Polyp location, use of a dedicated cold snare, and submucosal injection were not associated with incomplete resection. Intraprocedural bleeding requiring endoscopic intervention occurred in 4.7 %. CONCLUSIONS : CSP for polyps of 4-9 mm is safe and feasible; however, for lesions ≥ 10 mm, CSP failure occurs frequently, and the IRR remains high even after technical success. Incomplete resection was associated with flat polyps, visual residual polyp, piecemeal resection, and difficult polypectomies.

Role of the endoscopic Doppler probe in nonvariceal upper gastrointestinal bleeding: Systematic review and meta-analysis.

OBJECTIVES: The effectiveness of the Doppler endoscopic probe (DEP) remains unclear in nonvariceal upper gastrointestinal bleeding (NVUGIB). We thus performed a systematic review characterizing the effectiveness of DEP in patients with NVUGIB addressing this question. METHODS: A literature search was done until July 2021 using MEDLINE, EMBASE, and ISI Web of Science. A series of meta-analyses were performed assessing outcomes among observational and interventional studies for DEP signal positive and negative lesions as well as DEP-assisted versus standard endoscopies. The primary outcome was "overall rebleeding"; secondary outcomes included all-cause mortality, bleeding-related mortality, need for surgery, length of stay, intensive care unit stay, and angiography. RESULTS: Fourteen studies were included from 1911 citations identified. Observational studies compared bleeding lesions with DEP-positive versus DEP-negative signals (11 studies, n = 800 prehemostasis; five studies, n = 148 with posthemostasis data). Three interventional studies (n = 308) compared DEP-assisted to standard endoscopy management. DEP signal positive versus negative lesions either prior to or following any possible hemostasis were at greater risk of overall rebleeding (odds ratio [OR] 6.54 [2.36, 18.11] and OR 25.96 [6.74, 100.0], respectively). The use of DEP during upper endoscopy significantly reduced overall rebleeding rates (OR 0.27 [0.14, 0.54]). When removing outcomes analysis for which only one study was available, all evaluable outcomes were improved with DEP characterization of management guidance except for all-cause mortality. CONCLUSION: Although with low certainty evidence, DEP-related information improves on sole visual prediction of rebleeding in NVUGIB, with DEP-guided management yielding decreased overall rebleeding, bleeding-related mortality, and need for surgery.

TC-325 hemostatic powder in the management of upper gastrointestinal malignant bleeding: a randomized controlled trial.

Background and study aims Upper gastrointestinal bleeding (UGIB) from malignancy is associated with high rebleeding and mortality rates. Recently, TC-325 powder has shown promising results in the treatment of UGIB, including malignant bleeding. The aim of this study was to compare the efficacy of TC-325 versus best clinical management. Patients and methods From August 2016 to February 2020, all patients with evidence of UGIB from malignancy were randomized to receive TC-325 therapy or control group, in which endoscopic treatment was not mandatory. Exclusion criteria were hemoglobin drop without overt bleeding and UGIB from non-tumor origin. The primary outcome was 30-day mortality. Secondary outcomes were 30-day rebleeding, blood transfusion and length of hospital stay. Results Sixty-two patients were randomized, three were excluded and 59 were included in the final analysis (TC-325 group = 28; control = 31). Groups were similar at baseline. Active bleeding was observed in 22 patients in the TC-325 group and 19 in the control group ( P  = 0.15). Successful initial hemostasis with TC-325 was achieved in all cases. Additional therapy (radiotherapy, surgery or arterial embolization) was equally performed in both groups (42.9 % vs 58.1 %; P  = 0.243). There were no differences in 30-day mortality (28.6 % vs. 19.4 %, P  = 0.406) or 30-day rebleeding rates (32.1 % vs. 19.4 %, P  = 0.26). Logistic regression identified no significant predictors of rebleeding. Age, Eastern Cooperative Oncology Group (ECOG) score 3 to 4 and AIMS65 score > 1 predicted greater mortality. Conclusions TC-325 was effective in achieving immediate hemostasis in malignant gastrointestinal bleeding but did not reduce 30-day mortality, 30-day rebleeding, blood transfusion or length of hospital stay. Age, ECOG 3-4, and AIMS65 > 1 were predictive factors of mortality.