Project description: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.
Project description:Background and aimsAcute upper gastrointestinal bleeding (AUGIB) is one of the most life-threatening emergency conditions. Hemostatic drugs are often prescribed to control AUGIB in clinical practice but have not been recommended by major guidelines and consensus. The aim of this study was to investigate the therapeutic effect of hemostatic drugs on AUGIB in cirrhosis.MethodsAll cirrhotic patients with AUGIB who were admitted to our hospital from January 2010 to June 2014 were retrospectively included. Patients were divided into hemostatic drugs and no hemostatic drug groups. A 1 : 1 propensity score matching (PSM) analysis was performed by adjusting age, gender, etiology of liver disease, Child-Pugh score, MELD score, hematemesis, red blood cell transfusion, vasoactive drugs, antibiotics, proton pump inhibitors, and endoscopic variceal therapy. Primary outcomes included 5-day rebleeding and in-hospital mortality.ResultsOverall, 982 cirrhotic patients with AUGIB were included (870 in hemostatic drugs group and 112 in no hemostatic drug group). In overall analyses, hemostatic drugs group had a significantly higher 5-day rebleeding rate (18.10% versus 5.40%, P = 0.001) than no hemostatic drug group; in-hospital mortality was not significantly different between them (7.10% versus 4.50%, P = 0.293). In PSM analyses, 172 patients were included (86 patients in each group). Hemostatic drugs group still had a significantly higher 5-day rebleeding rate (15.10% versus 5.80%, P = 0.046); in-hospital mortality remained not significantly different (7.00% versus 3.50%, P = 0.304) between them. Statistical results remained in PSM analyses according to the type of hemostatic drugs.ConclusionsThe use of hemostatic drugs did not improve the in-hospital outcomes of cirrhotic patients with AUGIB.
Project description:Acute gastrointestinal bleeding (AGIB) is a prevalent condition with significant influence on healthcare costs. Endoscopy is essential for the management of AGIB with a pivotal role in diagnosis, risk stratification and management. Recently, hemostatic powders have been added to our endoscopic armamentarium to treat gastrointestinal (GI) bleeding. These substances are intended to control active bleeding by delivering a powdered product over the bleeding site that forms a solid matrix with a tamponade function. Local activation of platelet aggregation and coagulation cascade may be also boosted. There are currently three powders commercially available: hemostatic agent TC-325 (Hemospray(®)), EndoClot™ polysaccharide hemostatic system, and Ankaferd Bloodstopper(®). Although the available evidence is based on short series of cases and there is no randomized controlled trial yet, these powders seem to be effective in controlling GI bleeding from a variety of origins with a very favorable side effects profile. They can be used either as a primary therapy or a second-line treatment, and they seem to be especially indicated in cases of cancer-related bleeding and lesions with difficult access. In this review, we will comment on the mechanism of action, efficacy, safety and technical challenges of the use of powders in several clinical scenarios and we will try to define the main current indications of use and propose new lines of research in this area.
Project description:Background and study aims There is limited evidence on the effectiveness of hemostatic powders in the management of lower gastrointestinal bleeding (LGIB). We aimed to provide a pooled estimate of their effectiveness and safety based on the current literature. Patients and methods Literature review was based on computerized bibliographic search of the main databases through to December 2020. Immediate hemostasis, rebleeding rate, adverse events, and mortality were the outcomes of the analysis. Pooled effects were calculated using a random-effects model. Results A total of 9 studies with 194 patients were included in the meta-analysis. Immediate hemostasis was achieved in 95 % of patients (95 % confidence interval [CI] 91.6 %-98.5 %), with no difference based on treatment strategy or bleeding etiology. Pooled 7- and 30-day rebleeding rates were 10.9 % (95 %CI 4.2 %-17.6 %) and 14.3 % (95 %CI 7.3 %-21.2 %), respectively. Need for embolization and surgery were 1.7 % (95 %CI 0 %-3.5 %) and 2.4 % (95 %CI 0.3 %-4.6 %), respectively. Overall, two patients (1.9 %, 95 %CI 0 %-3.8 %) experienced mild abdominal pain after powder application, and three bleeding-related deaths (2.3 %, 95 %CI 0.2 %-4.3 %) were registered in the included studies. Conclusion Novel hemostatic powders represent a user-friendly and effective tool in the management of lower gastrointestinal bleeding.
Project description:BackgroundGastrointestinal tumor bleeding remains a clinical challenge because it is difficult to treat with conventional endoscopic hemostatic options. Recently, an endoscopic hemostatic powder (UI-EWD) was developed and reported to provide effective control of upper gastrointestinal bleeding. The aim of current study was to evaluate the feasibility and efficacy of this novel hemostatic powder in tumor bleeding.MethodsA total of 41 consecutive patients with upper gastrointestinal tumor bleeding were included. UI-EWD was applied in all patients as an auxiliary hemostatic method as a salvage therapy or monotherapy during endoscopic treatment. Hemostasis success rates, adverse event related to UI-EWD, and rates of re-bleeding were evaluated.ResultsIn all cases, UI-EWD application was successful at tumor bleeding sites. Immediate hemostasis occurred in 40/41 (97.5%) patients, and re-bleeding within 28 days occurred in 10 of 40 (22.5%) patients that achieved initial hemostasis. The success rate of immediate hemostasis for UI-EWD monotherapy was 100% (23/23). The re-bleeding rate at 28 days after UI-EWD monotherapy was 26.1% (6/23). No adverse events associated with UI-EWD application were encountered.ConclusionsThe success rate of UI-EWD for immediate hemostasis in cases of GI tumor bleeding was excellent and UI-EWD produced promising results with respect to the prevention of re-bleeding. Based on these results, we suggest that UI-EWD be considered an effective salvage therapy or even monotherapy for GI tumor bleeding.
Project description:To determine whether the Glasgow-Blatchford bleeding score (GBS) or pre-endoscopy Rockall score was better at accurately identifying patients with acute upper gastrointestinal bleeding (AUGIB) who were at low risk of the need for clinical intervention and death and therefore suitable for outpatient management.Retrospective database and case note review of all patients admitted to the emergency departments with AUGIB from 1 January 2008 to 31 December 2009.Two tertiary centre teaching hospitals.432 patients met the inclusion criteria.None.Clinical interventions (blood transfusion, endoscopic therapy and surgery) and death.Of 432 patients, 40 (9.3%) had a GBS of 0 and none required intervention or died. In contrast, 13/104 patients (12.5%) who had a pre-endoscopy Rockall score of 0 and 23/125 patients (18.4%) who had a complete Rockall score <3, required clinical intervention. The performance of the scores at these cut-offs were: GBS (sensitivity 100%, specificity 16.1%, positive predictive value (PPV) 37.8%, negative predictive value (NPV) 100%, accuracy 82.3%), pre-endoscopy Rockall (sensitivity 91.2%, specificity 32.0%, PPV 41.2%, NPV 87.5%, accuracy 70.9%) and complete Rockall (sensitivity 84.5%, specificity 50.7%, PPV 55.8%, NPV 81.6%, accuracy 76.2%). For prediction of the need for intervention or death, the accuracy of the GBS (0.82; 95% CI 0.78 to 0.86) was superior to the pre-endoscopy Rockall score (0.71; 95% CI 0.67 to 0.76).The GBS but not the pre-endoscopy Rockall score identifies patients with upper gastrointestinal bleeding who may be suitable for outpatient management, therefore potentially allowing for more efficient use of hospital resources.
Project description:AimTo perform a systematic review and meta-analysis of the weekend effect on the mortality of patients with upper gastrointestinal bleeding(UGIB).MethodsThe review protocol has been registered in the PROSPERO International Prospective Register of Systematic Reviews (registration number: CRD42017073313) and was written according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. We conducted a search of the PUBMED, COCHRANE, EMBASE and CINAHL databases from inception to August 2017. All observational studies comparing mortality between UGIB patients with weekend versus weekday admissions were included. Articles that were published only in abstract form or not published in a peer-reviewed journal were excluded. The quality of articles was assessed using the Newcastle-Ottawa Scale. We pooled results from the articles using random-effect models. Heterogeneity was evaluated by the chi-square-based Q-test and I2 test. To address heterogeneity, we performed sensitivity and subgroup analyses. Potential publication bias was assessed via funnel plot.ResultsEighteen observational cohort studies involving 1,232,083 study patients were included. Weekend admission was associated with significantly higher 30-day or in-hospital mortality in all studies (OR = 1.12, 95% CI [1.07-1.17], P < 0.00001). Increased in-hospital mortality was also associated with weekend admission (OR = 1.12, 95% CI [1.08-1.17], P < 0.00001). No significant difference in in-hospital mortality was observed between patients admitted with variceal bleeding during the weekend or on weekdays (OR = 0.99, 95% CI [0.91-1.08], P = 0.82); however, weekend admission was associated with a 15% increase in in-hospital mortality for patients with non-variceal bleeding (OR = 1.15, 95% CI [1.09-1.21], P < 0.00001). The time to endoscopy for weekday admission was significantly less than that obtained for weekend admission (MD = -2.50, 95% CI [-4.08--0.92], P = 0.002).ConclusionsThe weekend effect is associated with increased mortality of UGIB patients, particularly in non-variceal bleeding. The timing of endoscopic intervention might be a factor that influences mortality of UGIB patients.
Project description:BackgroundCap-mounted-clips, especially Over-The-Scope-Clip (OTSC™), are recommended for recurrent nonvariceal upper gastrointestinal bleeding (NVUGIB). There has been recent interest in their use as an initial hemostatic modality. We performed a systematic review of randomized controlled trials (RCTs) assessing cap-mounted clips' efficacy as a primary hemostatic modality in NVUGIB.MethodsA literature search of MEDLINE, EMBASE, and ISI Web of Science databases up to April 2024 identified RCTs comparing cap-mounted clips to standard endoscopic therapy (SET) as a primary hemostatic modality in NVUGIB. The primary endpoint was the composite outcome of further bleeding (persistent or recurrent) at 30 days. Secondary outcomes included persistent bleeding at index endoscopy and 30-day rebleeding, individually. Other pertinent outcomes were also recorded. A meta-analysis was performed to determine pooled risk ratios (RRs), comparing cap-mounted clip to SET. Out of 516 citations, five RCTs (n = 555), all assessing OTSC™, were included.ResultsThe composite outcome of further bleeding was lower with cap-mounted clip versus SET (RR = 0.33 [95% confidence interval {CI}: 0.20-0.54]). There was no difference in persistent bleeding at initial endoscopy (RR = 0.30 [95% CI: 0.07-1.30]), but 30-day rebleeding was lower with cap-mounted clip (RR = 0.38 [95% CI: 0.21-0.70]). There were no differences in other outcomes. Grading of the evidence ranged from very low to moderate, mainly due to risk of bias and imprecision.ConclusionsCap-mounted clips may be an efficacious primary hemostatic modality, associated with a lower further bleeding at 30 days compared to SET in NVUGIB. However, due to limitations in existing evidence, further research must better characterize an optimal subgroup of patients benefiting most from this approach before adopting its routine use.
Project description:To evaluate the effect of different prophylactic antibiotic treatments for cirrhosis patients with upper gastrointestinal bleeding (UGIB) and to investigate whether prophylactic antibiotics are equally beneficial to reducing the risk of adverse outcomes in A/B with low Child-Pugh scores. Relevant studies were searched via PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Internet (CNKI), Wanfang, and VIP databases up to July 16, 2021. The heterogeneity test was conducted for each outcome measuring by I2 statistics. Subgroup analysis was performed regarding antibiotic types. Relative risk (RR) and 95% confidence interval (CI) were used to evaluate prophylactic antibiotics on the risk of adverse outcomes in cirrhosis patients with UGIB. Twenty-six studies involving 12,440 participants fulfilled our inclusion criteria. Antibiotic prophylaxis was associated with a reduced overall mortality (RR: 0.691, 95%CI: 0.518 to 0.923), mortality due to bacterial infections (RR: 0.329, 95%CI: 0.144 to 0.754), bacterial infections (RR: 0.389, 95%CI: 0.340 to 0.444), rebleeding (RR: 0.577, 95%CI: 0.433 to 0.767) and length of hospitalization [weighted mean difference (WMD): -3.854, 95%CI: -6.165 to -1.543] among patients with UGIB. Nevertheless, prophylactic antibiotics may not benefit to A/B population with low Child-Pugh scores. In our subgroup analysis, quinolone, beta-lactams alone or in combination reduced adverse outcomes in cirrhosis patients with UGIB. Administration of antibiotics was associated with a reduction in mortality, bacterial infections, rebleeding, and length of hospitalization. Quinolone, beta-lactams alone or in combination can be used in cirrhosis patients with UGIB. Nevertheless, targeted efforts are needed to promote the appropriate use of antibiotics among patients with cirrhosis and UGIB.