Endoscopic treatment options in peptic ulcer bleeding.

This review evaluates the evidence for the use of over-the-scope clips (OTSC), topical haemostatic agents (THA), and prophylactic embolisation (PE) in patients with peptic ulcer bleeding (PUB). The use of OTSC and THA may have the potential to increase the rate of endoscopic haemostasis in PUB not responding to conventional endoscopic treatment. In patients at high risk of recurrent bleeding, the performance of PE after achieving endoscopic haemostasis can reduce the risk of rebleeding and the need for surgery. Implementation of a local treatment protocol including these modalities may improve patient outcomes.

[Recent aspects of pharmaceutical and endoscopic treatment of acute gastroduodenal ulcer bleeding]. / Az akut gastroduodenalis fekélyvérzés gyógyszeres és endoszkópos kezelésének újabb szempontjai.

Acute gastroduodenal ulcer bleeding is a life-threatening condition. Management of the acute gastroduodenal ulcer bleeding requires the cooperation of different specialists. The complex management program includes the immediate control of the hemodynamic status, transfusion and gastric acid inhibition therapy, endoscopic diagnosis, treatment and occasionally the invasive radiological interventions and surgery. According to the recent guidelines, pre-endoscopic parenteral proton-pump inhibitor therapy is recommended only for consideration. Urgent endoscopy (≤12 hours after admission) has no advantage to the early endoscopic (≤24 hours after admission) strategy. For ulcers with high rebleeding risk due to more than 2 cm in diameter, fibrotic base or wide visible vessel, the use of the "over-the-scope clip" is advisable even as a first-line endoscopic hemostatic therapy. Intermittent high-dose parenteral proton-pump inhibitor therapy is a new therapeutical option after endoscopic hemostasis. In patients with acute gastroduodenal bleeding who are taking low dose aspirin for secondary cardiovascular prophylaxis, aspirin should not be interrupted, while low dose aspirin administered for primary prophylaxis may be stopped. Orv Hetil. 2023; 164(23): 883-890.

Comparison between traumatic and atraumatic over-the-scope clips in patients with duodenal ulcer bleeding: a retrospective analysis with propensity score-based matching.

BACKGROUND AND AIMS: Over-the-scope clips (OTSCs) substantially improved the endoscopic armamentarium for the treatment of severe GI bleeding and can potentially overcome limitations of standard clips. Data indicate a superiority of OTSCs in hemostasis as first- and second-line therapy. However, the impact of the OTSC designs, in particular the traumatic (-t) or atraumatic (-a) type, in duodenal ulcer bleeding has not been analyzed so far. METHODS: This was a retrospective analysis of a prospective collected database from 2009 to 2020 of 6 German endoscopic centers. All patients who underwent emergency endoscopy and were treated using an OTSC for duodenal ulcer bleeding were included. OTSC-t and OTSC-a patients were compared by the Fisher exact test, χ2 test, or Mann-Whitney U test as appropriate. A propensity score-based 1:1 matching was performed to obtain equal distribution of baseline characteristics in both groups. RESULTS: The entire cohort comprised 173 patients (93 OTSC-a, 80 OTSC-t). Age, gender, anticoagulant therapy, Rockall score, and treatment regimen had similar distributions in the 2 groups. However, the OTSC-t group showed significantly more active bleeding ulcers (Forrest Ia/b). Matching identified 132 patients (66 in both groups) with comparable baseline characteristics. Initial bleeding hemostasis (OTSC-a, 90.9%; OTSC-t, 87.9%; P = .82) and 72-hour mortality (OTSC-a, 4.5%; OTSC-t, 6.0%; P > .99) were not significantly different, but the OTSC-t group revealed a clearly higher rate of recurrent bleeding (34.9% vs 7.6%, P < .001) and necessity of red blood cell transfusions (5.1 ± 3.4 vs 2.5 ± 2.4 concentrates, P < .001). CONCLUSIONS: For OTSC use, the OTSC-a should be the preferred option for duodenal ulcer bleeding.

Clinical outcomes of marginal ulcer bleeding compared with those of peptic ulcer bleeding.

BACKGROUND: Marginal ulcer bleeding (MUB) is a complication that can occur following several types of surgery. However, few studies exist on it. Therefore, this study aimed to compare the clinical outcomes of MUB with those of peptic ulcer bleeding (PUB). METHODS: Between January 2013 and December 2017, 5,076 patients underwent emergent esophagogastroduodenoscopy for suspected upper gastrointestinal bleeding. We retrospectively reviewed and analyzed the medical records of MUB and PUB patients and developed a propensity score matching (PSM) method to adjust for between-group differences in baseline characteristics with 1:2 ratios. Sex, age, body mass index (BMI), underlying diseases, and drugs were included as matching factors. RESULTS: A total of 64 and 678 patients were diagnosed with MUB and PUB, respectively, on emergent esophagogastroduodenoscopy, and 62 and 124 patients with MUB and PUB, respectively, were selected after PSM. Rebleeding was significantly higher in patients with MUB than in those with PUB (57.8% vs 9.1%, p < 0.001). Mortality caused by bleeding was higher in patients with MUB than in those with PUB (4.7% vs. 0.4%, p < 0.001). Multivariate analysis revealed that proton pump inhibitor (PPI) administration (odds ratio [OR], 0.14; 95% confidence interval [CI], 0.03-0.56; p = 0.011) after first bleeding was inversely correlated with MUB rebleeding. Large ulcer size (> 1 cm) (OR, 6.69; 95% CI, 1.95-27.94; p = 0.005) and surgery covering pancreas (OR, 3.97; 95% CI, 1.19-15.04) were independent risk factors for MUB rebleeding. CONCLUSIONS: MUB showed a severe clinical course than PUB. Therefore, MUB should be managed more cautiously, especially for large ulcers and pancreatic surgery. Prophylactic PPI administration may be helpful in reducing rebleeding in MUB.

Reduced mortality for over-the-scope clips (OTSC) versus surgery for refractory peptic ulcer bleeding: a retrospective study.

BACKGROUND: Surgery or transcatheter arterial embolization or are both considered as standard treatment of peptic ulcer bleeding (PUB) refractory to endoscopic hemostasis. Over-The-Scope clips (OTSC) have shown superiority to standard endoscopic treatment but a comparison with surgery has not been performed, yet. PATIENTS AND METHODS: In this retrospective, multicenter study, 103 patients treated with OTSC (n = 66) or surgery (n = 37) for refractory PUB in four tertiary care centers between 2009 and 2019 were analyzed. Primary endpoint was clinical success (successful hemostasis and no rebleeding within seven days). Secondary endpoints were adverse events, length of ICU-stay and in-hospital mortality. Univariable and multivariable regression models were performed to define predictive factors for allocation to surgical therapy and for mortality. RESULTS: Age, comorbidities, anticoagulation therapy, number of pretreatments, ulcer location, and Rockall-Score were similar in both groups. In the surgical group, there were significantly more patients in shock at rebleeding (78.1% vs. 43.9%; p = 0.002), larger ulcers (18.6 ± 7.4 mm vs. 23.0 ± 9.4 mm; p = 0.017) and more FIa bleedings (64.9% vs. 19.7%; p < 0.001) were detected. Clinical success was comparable (74.2% vs. 83.8%; p = 0.329). In the surgical group, length of ICU-stay (16.2 ± 18.0 days vs. 4.7 ± 6.6 days; p < 0.001), severe adverse events (70.3% vs. 4.5%; p < 0.001) and in-hospital mortality (35.1% vs. 9.1%; p = 0.003) were significantly higher. Multivariable analysis defined shock at rebleeding as the main predictor for allocation to surgical therapy (OR 4.063, 95%CI {1.496-11.033}, p = 0.006). Postsurgical adverse events were the main reason for the in-hospital mortality (OR 5.167, 95% CI {1.311-20.363}, p = 0.019). CONCLUSION: In this retrospective study, OTSC compared to surgical treatment showed comparable clinical success but was associated with shorter ICU-stay, less severe adverse events and lower in-hospital mortality.

Application of endoscopic purse-string sutures in high-risk peptic ulcer hemorrhage: preliminary experience of 38 cases.

OBJECTIVE: This study is a prospective study to explore the therapeutic effect of endoscopic purse-string sutures in high-risk peptic ulcer hemorrhage. PATIENTS AND METHODS: We prospectively collected and analyzed data from July 2018 to December 2020 from patients in Jinshan hospital, Fudan University, who underwent emergency endoscopy for acute severe high-risk non-variceal upper gastrointestinal hemorrhage (NVUGIB) and were treated with endoscopic purse-string sutures. RESULTS: We included 38 patients whose median age was 64 years (interquartile range: 57.2 - 71.2 years). All patients were high risk gastric ulcer larger than 1 cm, including Forrest Ia (n = 4, 10.5%), Forrest Ib (n = 13, 34.2%) and Forrest IIa (n = 21, 55.3%). All patients were treated with endoscopic purse-string sutures. The clinical success rate reached 89.5%. Three patients suffered from rebleeding within seven days, and were treated with surgery or arterial embolization, respectively, all of which successfully stopped bleeding. One patient died of myocardial infarction. All other patients were followed up for 30 days without bleeding. CONCLUSIONS: We conclude that endoscopic purse-string sutures seem to be safe and effective in the treatment of patients at high risk of ulcer bleeding.

Recurrent Bleeding From a Duodenal Ulcer Halted by Laparoscopic Oversewing Under Endoscopic Guidance.

Peptic ulcers are the most common causes of upper gastrointestinal bleeding. Although most peptic ulcer bleeding can be controlled by medical and endoscopic treatment, a small number of patients with recurrent bleeding eventually require surgical treatment. In recent years, laparoscopy, a minimally invasive surgical method, has gained popularity and acceptance. We, herein, report a case of recurrent duodenal ulcer bleeding. Laparoscopic oversewing of the bleeding ulcer under endoscopic guidance resulted in satisfactory recovery. We suggest that for recurrent bleeding from peptic ulcers, laparoscopic oversewing under endoscopic guidance should be recommended as a possible early option to halt the bleeding. Key Words: Upper gastrointestinal bleeding, Peptic ulcer, Laparoscopy, Treatment.

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 pilot study to evaluate the effectiveness and safety of urgent endoscopy for gastroduodenal perforation.

BACKGROUND: Gastroduodenal perforation is potentially life threatening and requires early diagnosis and treatment. Urgent endoscopy facilitates detecting bleeding sites and achieving hemostasis. However, there is no consensus on urgent endoscopy for gastroduodenal perforation in Japan. METHODS: We evaluated the effectiveness and safety of urgent endoscopy for gastroduodenal perforation. We compared clinical characteristics between 140 patients who underwent urgent endoscopy (urgent endoscopy group) and 16 patients did not (no urgent endoscopy group) at Hiroshima City Asa Citizens Hospital between December 2005 and December 2018. RESULTS: Endoscopic diagnosis was possible in all urgent endoscopy group. In contrast, correct diagnosis of the perforation site was made on CT in 99 cases (63%). Furthermore, the proportion of cases with correct diagnosis of the perforation site by CT findings differed significantly between the urgent endoscopy group and the no urgent endoscopy group (66% vs. 38%, p < 0.05). No complications of urgent endoscopy were observed. Primary perforation site was gastric in 42 cases and duodenal in 114. In the 42 gastric perforation cases, 12 gastric perforation cases (29%) were managed conservatively, successfully in 9 (75%); 2 cases (17%) required delayed emergency surgery for worsening peritonitis. In the 114 duodenal perforation cases (duodenal ulcer in all cases), 52 cases (46%) were managed conservatively, successfully in 48 (92%); 3 cases (6%) required delayed emergency surgery for worsening peritonitis. A significantly higher proportion of gastric perforation cases than duodenal perforation cases required surgical treatment (76% vs. 57%, p < 0.05). Multivariate analysis revealed localized abdominal pain (no peritonism) (OR 0.25; 95% CI 0.08-0.75; p < 0.01) and perforation diameter ≤ 5 mm (OR 0.13; 95% CI 0.04-0.36; p < 0.01) as significant independent clinical factors for successful conservative management of duodenal ulcer perforation. CONCLUSIONS: Urgent endoscopy in gastroduodenal perforation enabled primary diagnosis and perforation site identification, and facilitated deciding the management strategy.

Factors for unsuccessful endoscopic hemostasis in patients with severe peptic ulcer bleeding.

OBJECTIVES: Although the first approach for peptic ulcer bleeding is endoscopic hemostasis, quick determination of a hemostatic strategy is important in patients with vitals indicating shock. However, the unsuccessful factors for endoscopic treatment have yet to be sufficiently examined. We aimed to investigate the factors for unsuccessful endoscopic hemostasis in severe peptic ulcer bleeding. MATERIALS AND METHODS: Unsuccessful factors were retrospectively investigated in 150 eligible patients who underwent endoscopic hemostasis for shock-presenting peptic ulcer bleeding at our critical care center between April 2007 and March 2021. RESULTS: There were 123 and 27 cases of successful and unsuccessful endoscopic hemostasis, respectively. Causative diseases included gastric ulcer bleeding in 124 patients (82.7%) and duodenal ulcer bleeding in 26 patients (17.3%). Shock index (SI) (1.46 vs. 1.60) (p = .013), exposed blood vessel diameter (1.4 mm vs. 3.1 mm) (p < .001) identified on contrast-enhanced computed tomography (CE-CT), duodenal ulcer bleeding (p = .012), and Forrest classification Ia (p = .004) were extracted as independent factors for unsuccessful endoscopic hemostasis. In receiving operating curve analysis, when the cut-off value for the SI was set at 1.53, the sensitivity and specificity were 70.4% and 63.4%, respectively. When the cut-off value for the exposed blood vessel diameter was set at 1.9 mm, these were 88.9% and 83.7%, respectively. CONCLUSIONS: When these factors (SI ≥ 1.53, exposed blood vessel diameter ≥1.9 mm identified on CE-CT, duodenal ulcer bleeding, and Forrest Ia) are present in patients with severe peptic ulcer bleeding, non-endoscopic hemostasis, such as interventional radiology (IVR) and surgery, should be considered.

Oral Proton Pump Inhibitors May Be as Effective as Intravenous in Peptic Ulcer Bleeding: A Systematic Review and Meta-analysis.

INTRODUCTION: Current guidelines recommend intravenous (IV) proton pump inhibitor (PPI) therapy in peptic ulcer bleeding (PUB). We aimed to compare the efficacy of oral and IV administration of PPIs in PUB. METHODS: We performed a systematic search in 4 databases for randomized controlled trials, which compared the outcomes of oral PPI therapy with IV PPI therapy for PUB. The primary outcomes were 30-day recurrent bleeding and 30-day mortality. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated for dichotomous outcomes, while weighted mean differences (WMDs) with CI were calculated for continuous outcomes in meta-analysis. The protocol was registered a priori onto PROSPERO (CRD42020155852). RESULTS: A total of 14 randomized controlled trials reported 1,951 peptic ulcer patients, 977 and 974 of which were in the control and intervention groups, respectively. There were no statistically significant differences between oral and IV administration regarding 30-day rebleeding rate (OR = 0.96, CI: 0.65-1.44); 30-day mortality (OR = 0.70, CI: 0.35-1.40); length of hospital stay (WMD = -0.25, CI: -0.93 to -0.42); transfusion requirements (WMD = -0.09, CI: -0.07 to 0.24); need for surgery (OR = 0.91, CI: 0.40-2.07); further endoscopic therapy (OR = 1.04, CI: 0.56-1.93); and need for re-endoscopy (OR = 0.81, CI: 0.52-1.28). Heterogeneity was negligible in all analysis, except for the analysis on the length of hospitalization (I2 = 82.3%, P = 0.001). DISCUSSION: Recent evidence suggests that the oral administration of PPI is not inferior to the IV PPI treatment in PUB after endoscopic management, but further studies are warranted.

Duodenal perforation in a SARS-CoV-2-positive patient with negative PCR results for SARS-CoV-2 in the peritoneal fluid.

OBJECTIVE: The coronavirus disease 2019 (COVID-19) pandemic has significantly affected health care organizations globally. Many aspects of this disease, as well as the risks for patients treated with multiple drug regimens to control severe COVID-19, are unclear. During emergency surgery for SARS-CoV-2-positive patients, the risk of SARS-CoV-2 exposure and transmission to the surgical staff has yet to be determined. PATIENTS AND METHODS: In this report, we describe a SARS-CoV-2-positive patient with severe respiratory syndrome treated with multiple doses of IL-6 inhibitors who presented with a perforated duodenal ulcer and underwent emergency surgery. During and after surgery, we tested for SARS-CoV-2 at the ulcer site and in the peritoneal fluid. RESULTS: The history of the patient allows for two possible interpretations of the pathogenesis of the duodenal ulcer, which could have been a stress ulcer, or a gastrointestinal ulcer associated to the use of IL-6 inhibitors. We also noticed that the ulcer site and peritoneal fluid repeatedly tested negative for SARS-CoV-2. Therefore, we reviewed the pertinent literature on gastrointestinal bleeding in patients with COVID-19 and on SARS-CoV-2 detection in the peritoneal fluid of surgical patients and discussed possible prevention strategies for bleeding and the actual risk of infection for the surgical staff. CONCLUSIONS: The first implication of this case is that the relation between repeated administration of IL-6 inhibitors and upper gastrointestinal bleeding and perforation must be investigated, and that the threshold for administering prophylactic proton pump inhibitors therapy should be carefully considered for patients with severe COVID-19. The second implication is that further testing should be performed on the peritoneal fluid of COVID-19 patients undergoing emergency surgical procedures to clarify the discordant results for the presence of SARS-CoV-2 in the peritoneal cavity and the possible risk of transmission to the surgical staff.

Risk factors of perioperative mortality from complicated peptic ulcer disease in Africa: systematic review and meta-analysis.

Introduction: In 2013, peptic ulcer disease (PUD) caused over 300 000 deaths globally. Low-income and middle-income countries are disproportionately affected. However, there is limited information regarding risk factors of perioperative mortality rates in these countries. Objective: To assess perioperative mortality rates from complicated PUD in Africa and associated risk factors. Design: We performed a systematic review and a random-effect meta-analysis of literature describing surgical management of complicated PUD in Africa. We used subgroup analysis and meta-regression analyses to investigate sources of variations in the mortality rates and to assess the risk factors contributing to mortality. Results: From 95 published reports, 10 037 patients underwent surgery for complicated PUD. The majority of the ulcers (78%) were duodenal, followed by gastric (14%). Forty-one per cent of operations were for perforation, 22% for obstruction and 9% for bleeding. The operations consisted of vagotomy (38%), primary repair (34%), resection and reconstruction (12%), and drainage procedures (6%). The overall PUD mortality rate was 6.6% (95% CI 5.4% to 8.1%). It increased to 9.7% (95% CI 7.1 to 13.0) when we limited the analysis to studies published after the year 2000. The correlation was higher between perforated PUD and mortality rates (r=0.41, p<0.0001) than for bleeding PUD and mortality rates (r=0.32, p=0.001). Non-significant differences in mortality rates existed between sub-Saharan Africa (SSA) and North Africa and within SSA. Conclusion: Perioperative mortality rates from complicated PUD in Africa are substantially high and could be increasing over time, and there are possible regional differences.

Persisting bleeding from the duodenal ulcer in patients with occlusion of the celiac trunk: a case report.

INTRODUCTION: Endoscopic measures have continued to be the primary procedures in the management of ulcer bleeding. Nevertheless, in cases of failed endoscopic hemostasis and re-bleedings, endovascular techniques have gradually gained increased acceptance as an alternative to surgery, allowing to avoid surgical intervention in some cases. <br/> Case report: A case of a 42-year-old patient presenting to the authors' institution with massive bleeding from the duodenal ulcer, sprang from a pathologically enlarged gastroduodenal artery is reported. This vascular anomaly was a consequence of occlusion of the coeliac trunk (Dunbar syndrome), which was shown on an angio-CT scan. In spite of several endoscopic and endovascular measures, as well as three operations, the bleeding persistently recurred (a total of 6 episodes) and the patient eventually died. The article presents details of operative and endovascular treatments. Contemporary trends in management in cases of failed endoscopic interventions and re-bleedings form peptic ulcers are shown in the discussion.

Clipping Over the Scope for Recurrent Peptic Ulcer Bleeding is Cost-Effective as Compared to Standard Therapy: An Initial Assessment.

Clipping over the scope (C-OTS) is a novel closure technique used for the treatment of nonvariceal gastrointestinal bleeding, especially for high-risk lesions. C-OTS devices cost more than clipping through the scope and thermal devices. The high upfront cost of C-OTS may pose a barrier to its use and the cost-effectiveness of C-OTS for peptic ulcer disease bleeding is unknown. Cost-effectiveness studies of C-OTS for peptic ulcer bleeding as both first-line and second-line therapy can provide the current estimate of the conditions in which the use of C-OTS is cost-effective and give insights of the determinants to the cost-effectiveness of C-OTS.

The recurrent bleeding risk of a Forrest IIc lesion at the second-look endoscopy can be indicated by high Rockall scores ≥ 6.

BACKGROUND: The Forrest classification is widely applied to guide endoscopic hemostasis for peptic ulcer bleeding. Accordingly, practice guidelines suggest medical treatment only for ulcer with a Forrest IIc lesion because it has low rebleeding risk even without endoscopic therapy, ranging from 0 to 13%. However, the risk ranges widely and it is unclear who is at risk of rebleeding with such a lesion. This study assessed whether the Rockall score, which evaluates patients holistically, could indicate the risk of recurrent bleeding among patients with a Forrest IIc lesion at the second-look endoscopy. METHODS: Patients who had peptic ulcer bleeding with Ia-IIb lesions received endoscopic hemostasis at the primary endoscopy, and they were enrolled if their Ia-IIb lesions had been fading to IIc at the second-look endoscopy after 48- to 72-h intravenous proton pump inhibitor (PPI) infusion. Primary outcomes were rebleeding during the 4th-14th day and 4th-28th day after the first bleeding episode. RESULTS: The prospective cohort study enrolled 140 patients, who were divided into a Rockall scores ≥ 6 group or a Rockall scores < 6 group. The rebleeding rates in the Rockall scores ≥ 6 group and the Rockall scores < 6 group during the 4th-14th day and the 4th-28th day were 13/70 (18.6%) versus 2/70 (2.9%), p = 0.003 and 17/70 (24.3%) versus 3/70 (4.3%), p = 0.001, respectively, based on an intention-to-treat analysis and 5/62 (8.1%) versus 0/68 (0%), p = 0.023 and 6/59 (10.2%) versus 0/67 (0%), p = 0.009, respectively, based on a per-protocol analysis. The Kaplan-Meier curves showed that the Rockall scores ≥ 6 group had a significantly lower cumulative rebleeding-free proportion than the Rockall scores < 6 group (p = 0.01). CONCLUSIONS: Combined Rockall scores ≥ 6 on arrival with a Forrest IIc lesion at the second-look endoscopy can identify patients at risk of recurrent peptic ulcer bleeding following initial endoscopic and intravenous PPI treatment. Trial registration Trial registration identifier: NCT01591083.

Randomized controlled trial of hemostatic powder versus endoscopic clipping for non-variceal upper gastrointestinal bleeding.

BACKGROUND AND AIMS: Despite advances in pharmacological and endoscopic management of non-variceal upper gastrointestinal bleeding (NVUGIB), mortality is still relevant. TC-325 (Hemospray-Cook Medical) is a mineral powder with adsorptive properties, designed for endoscopic hemostasis. There are still no comparative trials studying this new hemostatic modality. The objective of this research was to compare the use of TC-325 (associated with epinephrine injection) with the combined technique of endoscopic clipping and epinephrine injection for the treatment of patients with NVUGIB. METHODS: We conducted a pilot randomized controlled trial with patients that presented NVUGIB with an actively bleeding lesion at the endoscopic evaluation. Patients were randomized either to the Hemospray or Hemoclip group. The randomization list was generated by a computer program and remained unknown throughout the entire trial. All patients underwent second-look endoscopy. RESULTS: Thirty-nine patients were enrolled. Peptic ulcer was the most frequent etiology. Primary hemostasis was achieved in all Hemospray cases and in 90% of Hemoclip group (p = 0.487). Five patients in Hemospray group underwent an additional hemostatic procedure during second-look endoscopy, while no patient in the Hemoclip group needed it (p = 0.04). Rebleeding, emergency surgery and mortality rates were similar in both groups. No toxicity, allergy events, or gastrointestinal obstruction signs were observed in Hemospray group. CONCLUSIONS: TC-325 presents similar hemostatic results when compared with conventional dual therapy for patients with NVUGIB. Hemospray's excellent primary hemostasis rate certifies it as a valuable tool in arduous situations of severe bleeding or difficult location site.

Over-the-scope clips are cost-effective in recurrent peptic ulcer bleeding.

Background: A recent prospective randomised controlled trial ('STING') showed superiority of over-the-scope clips compared to standard treatment in recurrent peptic ulcer bleeding. Cost-effectiveness studies on haemostasis with over-the-scope clips have not been reported so far. Objective: The aim of this study was to investigate whether the higher efficacy of the over-the-scope clips treatment outweighs the higher costs of the device compared to standard clips. Methods: For the analysis, the study population of the STING trial was used. Costs for the hospital stay in total as well as treatment-related costs were obtained. The average cost-effectiveness ratio, representing the mean costs per designated outcome, and the incremental cost-effectiveness ratio, expressing the additional costs of a new treatment strategy per difference in outcome were calculated. The designated outcome was defined as successful haemostasis without rebleeding within seven days, which was the primary endpoint of the STING trial. Average cost-effectiveness ratio and incremental cost-effectiveness ratio were calculated for total costs of the hospital stay as well as the haemostasis treatment alone. The cost-effectiveness analysis is taken from the perspective of the care provider.Results: Total costs and treatment-related costs per patient were 13,007.07 € in the standard group vs 12,808.56 € in the over-the-scope clip group (p = 0.812) and 2084.98 € vs 1984.71 € respectively (p = 0.663). The difference was not statistically significant. Total costs per successful haemostasis (average cost-effectiveness ratio) were 30,677.05 € vs 15,104.43 € and 4917.41 € vs 2340.46 € for the haemostasis treatment. The additional costs per successful haemostasis with over-the-scope clip treatment (incremental cost-effectiveness ratio) is -468.18 € for the whole treatment and -236.49€ for the haemostasis treatment. Conclusions: Over-the-scope clip treatment is cost-effective in recurrent peptic ulcer bleeding.