Cost-effectiveness and clinical outcomes of intermittent/continuous proton pump inhibitors infusion in high bleeding risk of ulcers: A retrospective observational cohort study.

ABSTRACT: The purpose of this study was to evaluate the clinical outcomes, including patient prognosis and medication expense, of proton pump inhibitors administered by high-dose continuous infusion (HDC, 80 mg loading dose, then 8 mg/h for 72 hours) or non-high-dose intermittent infusion (NHDI, 40 mg qd or 40 mg q12 h, for 3 days) regimens in high-risk patients with bleeding peptic ulcers.In this retrospective cohort study, patients with peptic ulcers and endoscopic hemostasis between January, 2013 and December, 2015 were included. The primary endpoints were rebleeding and mortality rates within 7 days. The secondary endpoints were length of stay (LOS), transfusion units of packed red blood cells (PRBCs), and the number needed to treat.A total of 335 patients met the inclusion criteria during the 3-year follow-up period. The cumulative incidence of rebleeding within 7 days was 20.4% and 11.2% in the HDC and NHDI groups, respectively, with a significant difference (P = .021). The mortality rate was 12.1% and 7.3% in the HDC and NHDI groups, respectively, with no significant difference (P = .136). Univariate Cox proportional hazards model analysis showed that the risk of rebleeding within 7 days in the HDC group was higher than that in the NHDI group. The hazard ratio for HDC vs. NHDI was 1.93 (P = .021). There were significant differences in LOS (P = .034) and PRBC units (P = .005) for risk of rebleeding within 7 days, as well as in transfusion units of PRBCs for mortality rate analysis (p < 0.001), between the HDC and NHDI groups. The results showed that the NHDI regimen could reduce the risk of rebleeding within 7 days in 1 of 11 patients (number needed to treat = 11) and could reduce medication cost by US$ 400 to 800.The NHDI regimen showed a lower risk of rebleeding within 7 days, shorter LOS, and fewer PRBC units than that of the HDC regimen. Receiving NHDI has better cost-effective outcomes than that of HDC for patients with high-risk bleeding peptic ulcers.

Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2021.

1: ESGE recommends in patients with acute upper gastrointestinal hemorrhage (UGIH) the use of the Glasgow-Blatchford Score (GBS) for pre-endoscopy risk stratification. Patients with GBS ≤ 1 are at very low risk of rebleeding, mortality within 30 days, or needing hospital-based intervention and can be safely managed as outpatients with outpatient endoscopy.Strong recommendation, moderate quality evidence. 2: ESGE recommends that in patients with acute UGIH who are taking low-dose aspirin as monotherapy for secondary cardiovascular prophylaxis, aspirin should not be interrupted. If for any reason it is interrupted, aspirin should be re-started as soon as possible, preferably within 3-5 days.Strong recommendation, moderate quality evidence. 3: ESGE recommends that following hemodynamic resuscitation, early (≤ 24 hours) upper gastrointestinal (GI) endoscopy should be performed. Strong recommendation, high quality evidence. 4: ESGE does not recommend urgent (≤ 12 hours) upper GI endoscopy since as compared to early endoscopy, patient outcomes are not improved. Strong recommendation, high quality evidence. 5: ESGE recommends for patients with actively bleeding ulcers (FIa, FIb), combination therapy using epinephrine injection plus a second hemostasis modality (contact thermal or mechanical therapy). Strong recommendation, high quality evidence. 6: ESGE recommends for patients with an ulcer with a nonbleeding visible vessel (FIIa), contact or noncontact thermal therapy, mechanical therapy, or injection of a sclerosing agent, each as monotherapy or in combination with epinephrine injection. Strong recommendation, high quality evidence. 7 : ESGE suggests that in patients with persistent bleeding refractory to standard hemostasis modalities, the use of a topical hemostatic spray/powder or cap-mounted clip should be considered. Weak recommendation, low quality evidence. 8: ESGE recommends that for patients with clinical evidence of recurrent peptic ulcer hemorrhage, use of a cap-mounted clip should be considered. In the case of failure of this second attempt at endoscopic hemostasis, transcatheter angiographic embolization (TAE) should be considered. Surgery is indicated when TAE is not locally available or after failed TAE. Strong recommendation, moderate quality evidence. 9: ESGE recommends high dose proton pump inhibitor (PPI) therapy for patients who receive endoscopic hemostasis and for patients with FIIb ulcer stigmata (adherent clot) not treated endoscopically. (A): PPI therapy should be administered as an intravenous bolus followed by continuous infusion (e. g., 80 mg then 8 mg/hour) for 72 hours post endoscopy. (B): High dose PPI therapies given as intravenous bolus dosing (twice-daily) or in oral formulation (twice-daily) can be considered as alternative regimens.Strong recommendation, high quality evidence. 10: ESGE recommends that in patients who require ongoing anticoagulation therapy following acute NVUGIH (e. g., peptic ulcer hemorrhage), anticoagulation should be resumed as soon as the bleeding has been controlled, preferably within or soon after 7 days of the bleeding event, based on thromboembolic risk. The rapid onset of action of direct oral anticoagulants (DOACS), as compared to vitamin K antagonists (VKAs), must be considered in this context.Strong recommendation, low quality evidence.

The effect of ankaferd blood stopper used for massive haemoptysis in a patient with mounier-kuhn syndrome: A case report.

Mounier-Kuhn Syndrome (MKS) is a rare disorder derived from the muscular and elastic tissue defects of the trachea and the main bronchial walls, characterized by tracheobronchomegaly. Patients may present with complaints of cough, phlegm, dyspnoea and haemoptysis. Haemoptysis may be minor and mixed with phlegm or it may be massive. Establishment of airway patency is a priority in the management of massive haemoptysis. Cold saline solution, diluted adrenaline or tranexamic acid may be administered via the endobronchial route to stop haemorrhage while establishing the airway patency. Ankaferd Blood Stopper (ABS) has a haemostatic property and can be locally administered to the airway. In this report, we aim to highlight the effects of ABS administered via an endobronchial route for emergency palliation of a patient with MKS presenting with massive haemoptysis.

Low-molecular-weight heparin followed by rivaroxaban for acute occlusive portomesenteric vein thrombosis in a cirrhotic patient treated with multiple endoscopic variceal procedures.

Acute portomesenteric vein thrombosis is potentially lethal. In the present paper, a cirrhotic patient with a previous history of esophageal variceal bleeding presented with acute occlusive portomesenteric vein thrombosis, but achieved complete recanalization by low-molecular-weight heparin followed by rivaroxaban. Notably, no bleeding episode occurred during anticoagulation therapy. This case supported early initiation of anticoagulation in such patients.

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.

SAFETY AND EFFICACY OF EUS-GUIDED COIL PLUS CYANOACRYLATE VERSUS CONVENTIONAL CYANOACRYLATE TECHNIQUE IN THE TREATMENT OF GASTRIC VARICES: A RANDOMIZED CONTROLLED TRIAL.

BACKGROUND: One of the most feared complications with the use of cyanoacrylate for treatment of gastric varices is the occurrence of potentially life-threatening systemic embolism. Thus, endoscopists are turning towards new techniques, including endoscopic coiling, as a potentially safer and more effective treatment option. However, no studies have been performed comparing the two techniques. OBJECTIVE: This study aims to compare the safety and efficacy of endoscopic ultrasound guided coil and cyanoacrylate injection versus the conventional technique of injection of cyanoacrylate alone. DESIGN: A pilot randomized controlled trial. METHODS: Patients randomized into group I were treated with coil and cyanoacrylate, and those in group II with cyanoacrylate alone. Flow within the varix was evaluated immediately after the treatment session and one month following initial treatment. If thrombosis was confirmed, additional follow-up was performed 4 and 10 months following initial treatment. All patients underwent a thoracic computerized tomography scan after the procedure. RESULTS: A total of 32 patients, 16 in each group, were followed for an average of 9.9 months (range 1-26 months). Immediately after the procedure, 6 (37.5%) group-I patients and 8 (50%) group-II patients presented total flow reduction in the treated vessel (P=0.476). After 30 days, 11 (73.3%) group-I patients and 12 (75%) group-II patients were found to have varix thrombosis. In both groups, the majority of patients required only one single session for varix obliteration (73.3% in group I versus 80% in group II). Asymptomatic pulmonary embolism occurred in 4 (25%) group-I patients and 8 (50%) group-II patients (P=0.144). No significant difference between the groups was observed. CONCLUSION: There is no statistical difference between endoscopic ultrasound guided coils plus cyanoacrylate versus conventional cyanoacrylate technique in relation to the incidence of embolism. However, a greater tendency towards embolism was observed in the group treated using the conventional technique. Both techniques have similar efficacy in the obliteration of varices. Given the small sample size of our pilot data, our results are insufficient to prove the clinical benefit of the combined technique, and do not yet justify its use, especially in light of higher cost. Further studies with larger sample size are warranted.

Avaliação clínica e endoscópica em pacientes com sintomas gastroesofágicos / Clinical and endoscopic evaluation in patients with gastroesophageal symptoms

ABSTRACT BACKGROUND: The gastroesophageal reflux disease (GERD) is the most common esophageal disease in medical practice, and it is suspected according to patients' symptoms. GERD can be classified in erosive esophagitis (EE) according to the presence of upper gastrointestinal endoscopy findings. OBJECTIVE: To evaluate endoscopic findings in patients with symptoms suggestive of GERD comparing epicemiological and risk factors. METHODS: Upper endoscopy reports were examined retrospectively from patients with symptoms of GERD such as heartburn, regurgitation, cough, throat clearing, globus and chest pain. EE was determined based on Los Angeles classification. Comparisons between risk factors in EE and non-EE groups were done with statistical analysis. RESULTS: A total of 984 endoscopic reports were examined and 676 selected for analysis (281 with EE and 395 with non-EE form). Most were female 381 (56.36%) with a mean age of 44.01±15.40 years. Hiatal hernia was present in 47(6.96%) and smoking in 41(6.07%). Univariate logistic regression showed that male (OR=2.24, CI 95%, 1.63-3.06) and hiatal hernia (OR=4.52, CI 95%, 2.30-8.89) were independent predictors of erosions in the EE group. The presence of hiatal hernia (OR=12.04, CI 95%, 3.57-40.62), smoking (OR=8.46, CI 95%, 3.28-31.32) and aged patients (OR=8.01, CI 95%, 2.42-26.49) were also indicated as a risk factor for severe EE (grades C and D of Los Angeles). CONCLUSION Male gender and hiatal hernia were associated with EE. Aged patients, smoking and hiatal hernia were related to severe EE. It is suggested that the risk factors for EE and non-EE types are different. Cohort studies are necessary to identify the exact mechanisms involved in each disease form.

RESUMO CONTEXTO: A doença do refluxo gastroesofágico (DRGE) é uma das doenças digestivas mais comuns na prática médica e deve ser suspeitada de acordo com os seus sintomas clínicos, podendo ser classificada em esofagite erosiva (EE) de acordo com os achados de endoscopia. OBJETIVO: Avaliar os achados endoscópicos em pacientes com sintomas sugestivos de DGRE comparando fatores de risco e epidemiológicos. MÉTODOS: Resultados de endoscopias digestiva foram examinados retrospectivamente de pacientes com sintomas relacionados com DRGE como pirose, regurgitação, tosse, pigarro, globus e dor torácica. EE foi determinada de acordo com a classificação de Los Angeles. Comparação de fatores de risco entre os grupos EE e não-EE foram feitos com análise estatística. RESULTADOS: Um total de 984 endoscopias foram examinadas e 676 endoscopias selecionadas para análise (281 com EE e 395 sem EE). A maioria dos pacientes era do sexo feminino 381 (56,36%) com uma idade média de 44,01±15,40 anos. Hérnia hiatal esteve presente em 47 (6,96%) e tabagismo em 41 (6,07%). Regressão logística uni variada mostrou que sexo masculino (OR=2,24 - IC 95%: 1,63-3,06) e hérnia hiatal (OR=4,52 - CI 95%: 2,30-8,89) foram fatores de risco independentes de EE. A presença de hérnia hiatal (OR=12,04 - CI 95%: 3,57-40,62), tabagismo (OR=8,46 - CI 95%: 3,28-31,32) e pacientes idosos (OR=8,01 - CI 95%, 2,42-26,49) foram fatores de risco no grupo de EE grave (classes C e D de Los Angeles). CONCLUSÃO: Sexo masculino e hérnia hiatal foram associados com EE. Idade avançada, tabagismo e hérnia hiatal foram relacionados à forma grave de EE. É sugerido que os fatores de risco de pacientes com e sem EE sejam diferentes. Estudos de coorte são necessários para identificar os mecanismos exatos envolvidos em cada forma da doença.

Segurança e eficácia do uso de cianoacrilato + coil guiado por ultrassom endoscópico versus técnica convencional de cianoacrilato no tratamento de varizes gástricas: um ensaio clínico randomizado / Safety and efficacy of eus-guided coil plus cyanoacrylate versus conventional cyanoacrylate technique in the treatment of gastric varices: a randomized controlled trial

ABSTRACT BACKGROUND: One of the most feared complications with the use of cyanoacrylate for treatment of gastric varices is the occurrence of potentially life-threatening systemic embolism. Thus, endoscopists are turning towards new techniques, including endoscopic coiling, as a potentially safer and more effective treatment option. However, no studies have been performed comparing the two techniques. OBJECTIVE: This study aims to compare the safety and efficacy of endoscopic ultrasound guided coil and cyanoacrylate injection versus the conventional technique of injection of cyanoacrylate alone. DESIGN: A pilot randomized controlled trial. METHODS: Patients randomized into group I were treated with coil and cyanoacrylate, and those in group II with cyanoacrylate alone. Flow within the varix was evaluated immediately after the treatment session and one month following initial treatment. If thrombosis was confirmed, additional follow-up was performed 4 and 10 months following initial treatment. All patients underwent a thoracic computerized tomography scan after the procedure. RESULTS: A total of 32 patients, 16 in each group, were followed for an average of 9.9 months (range 1-26 months). Immediately after the procedure, 6 (37.5%) group-I patients and 8 (50%) group-II patients presented total flow reduction in the treated vessel (P=0.476). After 30 days, 11 (73.3%) group-I patients and 12 (75%) group-II patients were found to have varix thrombosis. In both groups, the majority of patients required only one single session for varix obliteration (73.3% in group I versus 80% in group II). Asymptomatic pulmonary embolism occurred in 4 (25%) group-I patients and 8 (50%) group-II patients (P=0.144). No significant difference between the groups was observed. CONCLUSION: There is no statistical difference between endoscopic ultrasound guided coils plus cyanoacrylate versus conventional cyanoacrylate technique in relation to the incidence of embolism. However, a greater tendency towards embolism was observed in the group treated using the conventional technique. Both techniques have similar efficacy in the obliteration of varices. Given the small sample size of our pilot data, our results are insufficient to prove the clinical benefit of the combined technique, and do not yet justify its use, especially in light of higher cost. Further studies with larger sample size are warranted.

RESUMO CONTEXTO: Uma das complicações mais temidas com o uso de cianoacrilato para tratamento de varizes gástricas é a ocorrência de embolia sistêmica potencialmente fatal. Assim, os endoscopistas estão se aprimorando com novas técnicas, incluindo o uso de coils endoscópico, como uma opção de tratamento potencialmente mais segura e eficaz. No entanto, nenhum estudo foi realizado comparando as duas técnicas. OBJETIVO: Este estudo tem como objetivo comparar a segurança e eficácia da injeção de coil com cianoacrilato guiados por ultrassom endoscópico versus a técnica convencional de injeção de cianoacrilato. DESIGN: Um ensaio piloto controlado aleatoriamente. MÉTODOS: Os pacientes randomizados para o grupo I foram tratados com coil + cianoacrilato e os do grupo II apenas com cianoacrilato. O fluxo dentro da variz foi avaliado imediatamente após a sessão de tratamento e um mês após o tratamento inicial. Se a trombose foi confirmada, o acompanhamento adicional era realizado em 4 e 10 meses após o tratamento inicial. Todos os pacientes foram submetidos a uma tomografia computadorizada torácica após o procedimento. RESULTADOS: Um total de 32 pacientes, 16 em cada grupo, foram acompanhados por uma média de 9,9 meses (variação de 1-26 meses). Imediatamente após o procedimento, 6 (37,5%) pacientes do grupo I e 8 (50%) pacientes do grupo II apresentaram redução total do fluxo no vaso tratado (P=0,476). Após 30 dias, 11 (73,3%) pacientes do grupo I e 12 (75%) pacientes do grupo II apresentaram trombose da variz. Em ambos os grupos, a maioria dos pacientes necessitou de apenas uma única sessão para obliteração da variz (73,3% no grupo I versus 80% no grupo II). Embolia pulmonar assintomática ocorreu em 4 (25%) pacientes do grupo I e em 8 (50%) pacientes no grupo II (P=0,144). Nenhuma diferença significativa entre os grupos foi observada. CONCLUSÃO Apesar de não haver diferença estatística entre os dois grupos em relação à incidência de embolia neste estudo piloto, observou-se maior tendência de embolia no grupo tratado pela técnica convencional.

Continuous esomeprazole infusion versus bolus administration and second look endoscopy for the prevention of rebleeding in children with a peptic ulcer.

INTRODUCTION: the majority of studies of acute gastrointestinal bleeding in children are retrospective, focusing on therapeutic endoscopy. Previous studies performed in adult patients have demonstrated that both scheduled second look endoscopy and high dose continuous omeprazole infusion are effective in the prevention of peptic ulcer rebleeding. The aim of this study was to compare the efficacy of these two strategies using esomeprazole for the prevention of rebleeding following primary endoscopic hemostasis in children with peptic ulcers. The main outcome was to assess the rebleeding rate within 30 days after the initial hemostasis. METHODS: consecutive pediatric cases who underwent endoscopic treatment for bleeding peptic ulcers were randomized into two treatment groups following hemostasis. The first group received esomeprazole as an intravenous bolus every 12 hours for 72 hours and a routine second look endoscopy within 12-24 hours with endotherapy retreatment in the case of a persistent stigmata of bleeding. The second group received a continuous high dose esomeprazole infusion for 72 hours without endoscopic reassessment unless required due to rebleeding. RESULTS: a total of 63 children were randomized to the second look endoscopy group and 64 to the esomeprazole infusion group. Rebleeding occurred within 30 days in four patients (6.3%) in the first group and in three patients (4.6%) in the second group (p = 0.7). CONCLUSIONS: a pharmaceutical approach using a high dose continuous esomeprazole infusion in children after an initial endoscopic hemostasis has a similar efficacy compared to second look endoscopy and bolus esomeprazole administration for the prevention of peptic ulcer rebleeding. Thus, the discomfort of a second endoscopy in children can be avoided and is only recommended for selected high risk cases.

High-dose omeprazole infusion compared with scheduled second-look endoscopy for prevention of peptic ulcer rebleeding: a randomized controlled trial.

BACKGROUND AND STUDY AIM: Previous studies have shown that both scheduled second-look endoscopy and high-dose continuous omeprazole infusion are effective in preventing peptic ulcer rebleeding. The aim of this noninferiority trial was to compare the efficacy of these two strategies for the prevention of rebleeding following primary endoscopic hemostasis. PATIENTS AND METHODS: Consecutive patients who received endoscopic treatment for bleeding peptic ulcers (actively bleeding, with nonbleeding visible vessels) were randomized to two treatment groups following hemostasis. One group (second-look endoscopy group) received the proton pump inhibitor (PPI) omeprazole as an intravenous bolus every 12 hours for 72 hours and a second endoscopy within 16 - 24 hours with retreatment for persistent stigmata of bleeding. The other group (PPI infusion group) received continuous high-dose omeprazole infusion for 72 hours. Patients who developed rebleeding underwent surgery if repeat endoscopic therapy failed. The primary outcome was the rebleeding rate within 30 days after initial hemostasis. The margin for noninferiority was set at 5 %. RESULTS: A total of 153 patients were randomized to the PPI infusion group and 152 to the second-look endoscopy group. Rebleeding occurred within 30 days in 10 patients (6.5 %) in the PPI infusion group and in 12 patients (7.9 %) in the second-look endoscopy group (P = 0.646). Surgery was required for rebleeding in six patients from the PPI infusion group and three patients in the second-look endoscopy group (P = 0.32). Intensive care unit stay, transfusion requirements, and mortality were not different between the groups. Patients in the second-look endoscopy group were discharged 1 day earlier than those in the PPI infusion group (P < 0.001). CONCLUSIONS: After endoscopic hemostasis, high-dose PPI infusion was not inferior to second-look endoscopy with bolus PPI in preventing peptic ulcer rebleeding. TRIAL REGISTRATION: ClinicalTrials.gov (NCT: 00164931).

Cyanoacrylate therapy for the treatment of gastric varices: a new method.

OBJECTIVE: Cyanoacrylate (CYA) injection is recommended for bleeding gastric varices (GV) but with significant adverse effects. Transesophageal endoscopic ultrasound-guided therapy of large GV with a combined coil and CYA injection has shown promising results. However, it is expensive and requires technical expertise. In this study, we aimed to compare the safety and efficacy of a new method with UCYA [undiluated CYA (UCYA) followed by lipiodol-diluated CYA (DCYA)] in the management of large bleeding GV. METHODS: Fifteen consecutive patients with bleeding from large GV (>1 cm) were prospectively treated with DCYA and another 15 patients treated with UCYA retrospectively. All patients in the DCYA group underwent thoracic computed tomography scan to identify glue embolism. RESULTS: Baseline characteristics were similar between the two groups. Rates of GV obliteration and rebleeding were 100% vs 93.3% (P = 0.309) and 6.7% vs 33.3% (P = 0.06) in the DCYA and UCYA groups, respectively. One patient in the UCYA group had needle fixation which led to fatal bleeding after forceful needle extraction. In DCYA group none had glue embolism. CONCLUSIONS: Both UCYA and DCYA are effective in treating bleeding from large GV. DCYA has lower rebleeding rates and tends to have fewer adverse events than UCYA injection, although the differences are not statistically significant. Large-sample-sized prospective randomized trials are required.

Intravenous Esomeprazole for Prevention of Peptic Ulcer Rebleeding: A Randomized Trial in Chinese Patients.

INTRODUCTION: High-dose intravenous esomeprazole is the only approved pharmacological treatment for the prevention of peptic ulcer rebleeding (currently approved in over 100 countries worldwide), but has not yet been approved in China. This study aimed to evaluate a high-dose esomeprazole intravenous regimen vs. an active control (cimetidine) for the prevention of rebleeding in Chinese patients with a high risk of peptic ulcer rebleeding who had undergone primary endoscopic hemostatic treatment. METHODS: This was a parallel-group study conducted at 20 centers in China. The study comprised a randomized, double-blind, intravenous treatment phase of 72 h in which 215 patients received either high-dose esomeprazole (80 mg + 8 mg/h) or cimetidine (200 mg + 60 mg/h), followed by an open-label oral treatment phase in which all patients received esomeprazole 40 mg tablets once daily for 27 days. The primary outcome was the rate of clinically significant rebleeding within the first 72 h after initial endoscopic hemostatic therapy. Secondary outcomes included the rates of clinically significant rebleeding within 7 and 30 days; proportions of patients who had endoscopic retreatment and other surgery due to rebleeding; and number of blood units transfused. RESULTS: The rate of clinically significant rebleeding within 72 h was low overall (3.3%) and numerically lower in patients treated with esomeprazole compared with cimetidine (0.9% vs. 5.6%). Overall, the results of the secondary outcomes also showed a numerical trend towards superiority of esomeprazole over cimetidine. All treatments were well tolerated. CONCLUSION: In this phase 3, multicenter, randomized trial conducted in China, esomeprazole showed a numerical trend towards superior clinical benefit over cimetidine in the prevention of rebleeding in patients who had successfully undergone initial hemostatic therapy of a bleeding peptic ulcer, with a similar safety and tolerability profile. These findings suggest that esomeprazole may be an alternative treatment option to cimetidine for this indication in China. FUNDING: AstraZeneca. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01757275.

Endoscopic injection of autologous blood versus diluted epinephrine for control of actively bleeding gastroduodenal ulcers: a randomized-controlled study.

INTRODUCTION: A preliminary report showed that autologous blood is an effective and easily applicable technique that can control actively bleeding gastroduodenal ulcers. The aim of this study was to test whether an endoscopic injection of autologous blood is comparable to an endoscopic injection of diluted epinephrine in controlling bleeding from gastroduodenal ulcers. PATIENTS AND METHODS: A total of 100 patients with actively bleeding gastroduodenal ulcers were assigned randomly to either an autologous blood injection (group A, n=50) or a diluted epinephrine injection (group B, n=50) along the edges of the ulcers. Groups were compared for rates of initial hemostasis, rebleeding, and complications. RESULTS: All patients initially achieved hemostasis (100%). Rebleeding occurred in four patients from group A (8%) and five patients from group B (10%). Two patients in group B developed cardiovascular complications (arrhythmia and ischemic heart attack), whereas none in group A developed complications. CONCLUSION: Autologous blood is effective, comparable to diluted epinephrine in achieving initial hemostasis from actively bleeding gastroduodenal ulcers, associated with an 8% rebleeding rate, and led to no complications.

Comparison of clinical effectiveness of the emergent colonoscopy in patients with hematochezia according to the type of bowel preparation.

BACKGROUND AND AIMS: Colonoscopy (CFS) is a valuable diagnostic tool in patients with hematochezia. However, the optimal preparation method of emergent CFS for hematochezia has not been defined. We investigated the clinical effectiveness of bowel preparation of patients with hematochezia using polyethylene glycol (PEG) solution and glycerin or water enemas. METHODS: The medical records of the past 7 years were reviewed. Patients presenting with hematochezia that occurred within 24 h before admission were eligible for the study. All patients underwent CFS within 24 h after visiting the emergency room for hematochezia. Patients were classified into two groups according to the preparation method used (enema vs. PEG). RESULTS: Overall, 194 patients (125 enema vs. 69 PEG) were enrolled. The diagnostic rate of bleeding focus was lower in the enema group than in the PEG group (84% vs. 97.1%, P = 0.008). Performance of endoscopic hemostasis at the initial CFS was more frequent in the enema group than in the PEG group (40.8% vs. 10.1%, P < 0.001). The rate of repeated CFS was higher in the enema group than in the PEG group (44.0% vs. 18.8%, P < 0.001). Post-polypectomy bleeding (n = 33) was diagnosed during the initial study and was treated endoscopically. In cases of post-polypectomy bleeding, CFS (93.9%) was performed after an enema in all but two cases. CONCLUSIONS: In hematochezia patients, the PEG group showed a higher diagnostic rate and lower rate of repeated CFS. However, emergent CFS after an enema only seems to be useful in patients with severe hematochezia or if the bleeding focus can be presumed.

Efficacy and safety of over-the-scope clip: including complications after endoscopic submucosal dissection.

AIM: To retrospectively review the results of over-the-scope clip (OTSC) use in our hospital and to examine the feasibility of using the OTSC to treat perforations after endoscopic submucosal dissection (ESD). METHODS: We enrolled 23 patients who presented with gastrointestinal (GI) bleeding, fistulae and perforations and were treated with OTSCs (Ovesco Endoscopy GmbH, Tuebingen, Germany) between November 2011 and September 2012. Maximum lesion size was defined as lesion diameter. The number of OTSCs to be used per patient was not decided until the lesion was completely closed. We used a twin grasper (Ovesco Endoscopy GmbH, Tuebingen, Germany) as a grasping device for all the patients. A 9 mm OTSC was chosen for use in the esophagus and colon, and a 10 mm device was used for the stomach, duodenum and rectum. The overall success rate and complications were evaluated, with a particular emphasis on patients who had undergone ESD due to adenocarcinoma. In technical successful cases we included not only complete closing by using OTSCs, but also partial closing where complete closure with OTSCs is almost difficult. In overall clinical successful cases we included only complete closing by using only OTSCs perfectly. All the OTSCs were placed by 2 experienced endoscopists. The sites closed after ESD included not only the perforation site but also all defective ulcers sites. RESULTS: A total of 23 patients [mean age 77 years (range 64-98 years)] underwent OTSC placement during the study period. The indications for OTSC placement were GI bleeding (n = 9), perforation (n = 10), fistula (n = 4) and the prevention of post-ESD duodenal artificial ulcer perforation (n = 1). One patient had a perforation caused by a glycerin enema, after which a fistula formed. Lesion closure using the OTSC alone was successful in 19 out of 23 patients, and overall success rate was 82.6%. A large lesion size (greater than 20 mm) and a delayed diagnosis (more than 1 wk) were the major contributing factors for the overall unsuccessful clinical cases. The location of the unsuccessful lesion was in the stomach. The median operation time in the successful cases was 18 min, and the average observation time was 67 d. During the observation period, none of the patients experienced any complications associated with OTSC placement. In addition, we successfully used the OTSC to close the perforation site after ESD in 6 patients. This was a single-center, retrospective study with a small sample size. CONCLUSION: The OTSC is effective for treating GI bleeding, fistulae as well as perforations, and the OTSC technique proofed effective treatment for perforation after ESD.

Novel predictors for immediate puncture site bleed during endoscopic glue injection for gastric varices without using lipiodol.

Endoscopic obturation of gastric varices using tissue adhesive glues like cyanoacrylate is an accepted modality for the treatment of gastric varices. This study was undertaken to determine whether it was possible to predict immediate puncture site bleed on withdrawal of needle catheter during endoscopic glue injection without lipiodol. We prospectively analyzed 100 consecutive patients with cirrhosis who underwent glue injection. Glue injection was successful in all the patients. Immediate puncture site bleed was observed in only four cases and all of them correlated with negative catheter pull sign and positive red catheter sign. Catheter pull sign and red catheter sign were excellent predictors of immediate puncture site bleed during endoscopic glue injection and should be routinely tested.