Adding a sclerosant to endoscopic epinephrine injection in actively bleeding ulcers: a randomized trial. Injection therapy of bleeding peptic ulcer. A prospective, randomized trial using epinephrine and thrombin. Comparison of hemostatic efficacy for epinephrine injection alone and injection combined with hemoclip therapy in treating high-risk bleeding ulcers. Role of intravenous omeprazole in patients with high-risk peptic ulcer bleeding after successful endoscopic epinephrine injection: a prospective randomized comparative trial. Oral or intravenous proton pump inhibitor in patients with peptic ulcer bleeding after successful endoscopic epinephrine injection. Is sclerosant injection mandatory after an epinephrine injection for arrest of peptic ulcer haemorrhage? A prospective, randomised, comparative study. Endoscopic injection therapy for bleeding peptic ulcer; a comparison of adrenaline alone with adrenaline plus ethanolamine oleate. Proton pump inhibitors after endoscopic hemostasis in patients with peptic ulcer bleeding. Comparison of the hemostatic efficacy of the endoscopic hemoclip method with hypertonic saline-epinephrine injection and a combination of the two for the management of bleeding peptic ulcers. A prospective, randomized trial comparing mechanical methods of hemostasis plus epinephrine injection to epinephrine injection alone for bleeding peptic ulcer. Endoscopic treatment for bleeding peptic ulcers: randomised comparison of adrenaline injection and adrenaline injection + Nd:YAG laser photocoagulation. Randomised comparison between adrenaline injection alone and adrenaline injection plus heat probe treatment for actively bleeding ulcers. Endoscopic injection for bleeding peptic ulcer: a comparison of adrenaline alone with adrenaline plus human thrombin. Epinephrine versus epinephrine plus fibrin glue injection in peptic ulcer bleeding: a prospective randomized trial.
We compared the efficacy of epinephrine injection and epinephrine injection followed by sodium tetradecyl sulfate in controlling active ulcer bleeding. Out of 2814 patients who underwent endoscopy for gastrointestinal bleeding, 200 patients with actively bleeding ulcers seen at the time of endoscopy were randomized to receive epinephrine injection alone (99 patients) or epinephrine injection followed by 3% sodium tetradecyl sulfate (101 patients). After the procedure the patients were transferred to the surgical gastroenterology ward and were treated by surgeons who were unaware of the mode of treatment. The patients underwent routine endoscopy 24 hours later, and epinephrine injection was repeated if active bleeding was seen again. Emergency surgery was performed for the following: (1) arterial spurting not controlled endoscopically, (2) failure of the blood pressure or pulse to stabilize after 4 units of blood, (3) total transfusion of more than 8 units of blood, or (4) rebleeding as defined by hematemesis with pulse greater than 100 beats/min or blood pressure less than 100 mm Hg after stabilization. The two groups were comparable in age, sex, site of ulcer, and severity of bleeding. Initial hemostasis was obtained at the time of endoscopy in 94% of the epinephrine group and 97% of the epinephrine plus sodium tetradecyl sulfate group. No difference in outcome was seen in the two groups as measured by emergency surgery requirement, blood transfusion, hospital stay, and hospital mortality. Endoscopic epinephrine injection is effective in controlling active ulcer bleeding. The additional injection of sodium tetradecyl sulfate confers no additional advantage. A prospective randomized trial involving 64 patients with bleeding peptic ulcers was performed to assess the efficacy of two modalities of injection therapy. The inclusion criterion was the presence of active bleeding or a visible vessel at emergency endoscopy. Thirty-two patients were treated with epinephrine (Group A) and 32 with epinephrine plus thrombin (Group B). Permanent hemostasis was achieved in 81.3% Group A, and 84.4% Group B patients, and therapy failures occurred in 18.6% and 15.6%, respectively. Mortality was nil in both groups. There were no differences in the requirement for emergency surgery, or in the number of transfusions in the two groups. A second elective endoscopy was performed in 49 patients between the 3rd and the 5th day after admission, proceeding to a second injection therapy if a visible vessel was still seen. There were no failures among re-injected patients. With one exception, none of the failures occurred in patients in whom a second endoscopy was done. Our results suggest that injection therapy, which is a simple technique, should be considered as the initial treatment of choice in bleeding peptic ulcer. The addition of thrombin to epinephrine does not improve the results of the method. An early second endoscopy and local therapy if a visible vessel is still present, may further improve the results. Rebleeding occurs in 10% to 30% of bleeding ulcer patients receiving endoscopic epinephrine injection therapy. It remains unclear whether addition of a secondary clip therapy following epinephrine injection may reduce the rebleeding rate of high-risk bleeding ulcers.
                To compare the efficacies of epinephrine injection alone and epinephrine injection combined with hemoclip therapy in treating high-risk bleeding ulcers.
                Prospective randomized controlled trial.
                A medical center in Taiwan.
                One hundred five bleeding ulcer patients with active spurting, oozing, nonbleeding visible vessels or adherent clots in ulcer bases.
                Endoscopic combination therapy (n = 52) or diluted epinephrine injection alone (n = 53).
                Initial hemostasis rates and recurrent bleeding rates.
                Initial hemostasis was achieved in 51 patients treated with combination therapy and 49 patients with epinephrine injection therapy (98% vs 92%, P = .18). Bleeding recurred in 2 patients in the combination therapy group and 11 patients in the epinephrine injection group (3.8% vs 21%, P = .008). Among the patients with rebleeding, repeated combination therapy was more effective than repeated injection therapy in achieving permanent hemostasis (100% vs 33%, P = .02). No patient required an emergency operation in the combination therapy group. However, 5 patients in the epinephrine injection group underwent emergency surgery to arrest bleeding (0% vs 9%, P = .023).
                Treatment outcome of endoscopic hemoclip therapy is related to the techniques of endoscopists.
                Endoscopic combination therapy is superior to epinephrine injection alone in the treatment of high-risk bleeding ulcers. Epinephrine injection is the most common endoscopic therapy for peptic ulcer bleeding. Controversy exists concerning the optimal dose of proton pump inhibitors (PPI) for patients with bleeding peptic ulcers after successful endoscopic therapy. The objective of this study was to determine the optimal dose of PPI after successful endoscopic epinephrine injection in patients with bleeding peptic ulcers.
                A total of 200 peptic ulcer patients with active bleeding or nonbleeding visible vessels (NBVV) who had obtained initial hemostasis with endoscopic injection of epinephrine were randomized to receive omeprazole 40 mg infusion every 6 h, omeprazole 40 mg infusion every 12 h or cimetidine (CIM) 400 mg infusion every 12 h. Outcomes were checked at 14 days after enrollment.
                Rebleeding episodes were fewer in the group with omeprazole 40 mg infusion every 6 h (6/67, 9%) as compared with that of the CIM infusion group (22/67, 32.8%, p < 0.01). The volume of blood transfusion was less in the group with omeprazole 40 mg every 6 h than in those groups with omepraole 40 mg infusion every 12 h (p= 0.001) and CIM 400 mg infusion every 12 h (p < 0.001). The hospital stay, number of patients requiring urgent operation, and death rate were not statistically different among the three groups.
                A combination of endoscopic epinephrine injection and a large dose of omeprazole infusion is superior to combined endoscopic epinephrine injection with CIM infusion for preventing recurrent bleeding from peptic ulcers with active bleeding or NBVV. We aimed to assess the clinical effectiveness of oral vs. intravenous (i.v.) regular-dose proton pump inhibitor (PPI) after endoscopic injection of epinephrine in patients with peptic ulcer bleeding.
                Peptic ulcer patients with active bleeding, nonbleeding visible vessels, or adherent clots were enrolled after successful endoscopic haemostasis achieved by epinephrine injection. They were randomized to receive either oral rabeprazole (RAB group, 20 mg twice daily for 3 days) or i.v. omeprazole (OME group, 40 mg i.v. infusion every 12 h for 3 days). Subsequently, the enrolled patients receive oral PPI for 2 months (rabeprazole 20 mg or esomeprazole 40 mg once daily). The primary end-point was recurrent bleeding up to 14 days. The hospital stay, blood transfusion, surgery and mortality within 14 days were compared as well.
                A total of 156 patients were enrolled, with 78 patients randomly allocated in each group. The two groups were well matched for factors affecting the clinical outcomes. Primary end-points (recurrent bleeding up to 14 days) were reached in 12 patients (15.4%) in the OME group and 13 patients (16.7%) in the RAB group [95% confidence interval (CI) of difference -12.82, 10.22]. All the rebleeding events occurred within 3 days of enrolment. The two groups were not different in hospital stay, volume of blood transfusion, surgery or mortality rate (1.3% of the OME group and 2.6% of the RAB group died, 95% CI of difference -5.6, 3.0).
                Oral rabeprazole and i.v. regular-dose omeprazole are equally effective in preventing rebleeding in patients with high-risk bleeding peptic ulcers after successful endoscopic injection with epinephrine. A prospective, randomised, comparative study was performed to assess the need for a pure alcohol injection after an epinephrine injection in the arrest of active peptic ulcer bleeding. Sixty four patients with active ulcer bleeding were enrolled in the study. The two groups (epinephrine and epinephrine plus pure alcohol) were matched for sex, age, site of bleed, endoscopic findings, shock, haemoglobin, and concomitant illness at randomisation. The volume of injected epinephrine in the epinephrine and the epinephrine plus pure alcohol groups mean (SD) was 6.0 (3.0) ml and 5.5 (3.0) ml respectively (p > 0.05). The volume of injected pure alcohol in the epinephrine plus pure alcohol group was 1.9 (1.1) ml. Bleeding was initially controlled in 31 (97%) of the epinephrine group and all of the epinephrine plus pure alcohol group. Rebleeding occurred in 11 (36%) of the epinephrine group and in five (16%) of the epinephrine plus pure alcohol group (p > 0.05). Rebleeding was successfully controlled in some patients with treatment by a second injection. Other patients had heat probe thermocoagulation or surgery. Ultimate haemostatic rates were 69% (22/32) and 88% (28/32) for the epinephrine and the epinephrine plus pure alcohol groups respectively (p > 0.05). The epinephrine plus pure alcohol group achieved a better haemostatic effect for spurting haemorrhage (9/10 v 5/11, p < 0.05). The need for emergency operations and blood transfusions were comparable in both groups. The stay in hospital were less in the epinephrine plus pure alcohol group (mean 4.3 v 7.1, p < 0.05). It is concluded that pure alcohol injection after an epinephrine injection can improve the haemostatic rate in patients with spurting haemorrhage and shorten the hospital stay for patients with active bleeding. One hundred and seven consecutive patients presenting with significant peptic ulcer haemorrhage were randomised to endoscopic injection with 3-10 ml of 1:100,000 adrenaline (55 patients, group 1) or to a combination of adrenaline and 5% ethanolamine (52 patients, group 2). All had major stigmata of haemorrhage and endoscopic injection was undertaken by a single endoscopist. The groups were well matched with regard to risk factors. Rebleeding occurred in eight of the group 1 patients and seven in the group 2 patients; surgical operation rates, median blood transfusion requirements, and hospital stay were similar in both groups. The efficacy of either form of injection was similar whether patients presented with active bleeding or a non-bleeding visible vessel. No complications occurred. In patients presenting with significant peptic ulcer bleeding, the addition of a sclerosant confers no advantage over injection with adrenaline alone. Peptic ulcer bleeding is a common and potentially fatal condition. For patients with bleeding peptic ulcers that display major endoscopic stigmata of recent hemorrhage, a combination of endoscopic and pharmacologic therapy is the current standard management.
                To show our experience with management of peptic ulcer bleeding.
                Patients who presented with gastrointestinal bleeding caused by peptic ulcer or recent history (< 24 h before presentation) of hematemesis and/or melena admitted to our hospital emergency departments, and patients whose ulcer hemorrhage started after hospitalization for an unrelated medical or surgical condition.
                Patients with actively bleeding ulcers and those with nonbleeding visible vessel or adherent clot were treated with epinephrine injection and/or endoscopic hemoclips, and randomized to receive intravenous pantoprasole according to the continuous regimen (dose of 5 x 40 mg in continuous infusion of 8 mg/h for 72 h) or the standard regimen (40 mg bolus of PPI twice daily for 3 days). After the infusion, all patients were given 40 mg PPI twice daily orally. The primary end point was the in-hospital rebleeding rate, as discovered by the repeated endoscopy.
                Bleeding recurred in 5 of 34 patients (14.7%) receiving the intensive regimen, and in 8 of 35 (22.8%) patients receiving the standard regimen. Hemoglobin (g/l) rate in standard regimen group was 93.5 +/- 23.8, and in intensive regimen group 106.6 +/- 22.4 (P = 0.042). Mean units of blood transfused for all patients in group were 71.8 +/- 45.8 in the intensive and 45.3 +/- 50.2 in the standard regimen group (P = 0.0257). The duration of hospital stay was 6.4 +/- 2.8 in standard group and 5.8 +/- 2.8 in the intensive group (P = 0.40).
                In patients with bleeding peptic ulcers with successful endoscopic hemostasis the standard PPI regimen had advantage on transfusion requirements, but no advantage with respect to in-hospital rates of rebleeding rates, need for surgery, length of hospital stay, or death, which corresponds with recent studies. The endoscopic hemoclip method is a safe and effective hemostatic method for managing bleeding peptic ulcers. We compared the hemostatic efficacy of the endoscopic hemoclip method with that of hypertonic saline-epinephrine (HSE) injection and a combined method in the management of bleeding peptic ulcers.
                From July 1994 to July 1997, we conducted a randomized clinical trial of endoscopic hemostasis involving 124 patients with actively bleeding or visible vessels at endoscopic inspection.
                Patients were randomly assigned to hemoclip (41 patients), HSE (41 patients), and combined treatment groups (42 patients). Initial hemostasis was achieved in 97.6%, 95.1%, and 97.6% of cases, respectively. Recurrent bleeding developed in 2.4%, 14.6%, and 9.5% of cases. Emergency operations were performed in 4.9%, 14.6%, and 2.3% of cases. The hemostasis rate was 71.4%, 50%, and 66.7% for spurting hemorrhage in each group. Permanent hemostasis was achieved in 95.1%, 85.4%, and 95.2% of cases. Three patients had complications, all in the HSE group.
                The hemoclip method is an effective hemostatic procedure and is safer than HSE injection. The combined method does not provide substantial advantage over use of the hemoclip method alone in the hemostatic management of bleeding peptic ulcers. The hemostatic efficacy of mechanical methods of hemostasis, together with epinephrine injection, was compared with that of epinephrine injection alone in bleeding peptic ulcer.
                Ninety patients with a peptic ulcer with active bleeding or a non-bleeding visible vessel were randomly assigned to undergo a mechanical method of hemostasis (23 hemoclip application, 22 band ligation) plus epinephrine injection, or epinephrine injection alone.
                The two groups were similar with respect to all background variables. Initial hemostasis was achieved in 44/45 (97.8%) patients in both groups. The mean number of hemoclips and elastic bands applied were 2.8: 95% CI[2.5, 3.1] and 1.1: 95% CI[1.0, 1.2], respectively, and the mean volume of epinephrine injected was 19.9 mL: 95% CI[19.3 mL, 20.5 mL]. The rate of recurrent bleeding in the combination group (2/44, 4.5%) was significantly lower in comparison with the injection group (9/44, 20.5%, p < 0.05). The mean number of therapeutic endoscopic sessions needed to achieve permanent hemostasis in the combination group (1.04: 95% CI[1.01, 1.07]) was significantly lower vs. the injection group (1.22: 95% CI[1.15, 1.30]).
                The combination of an endoscopic mechanical method of hemostasis plus epinephrine injection is more effective than epinephrine injection alone for the treatment of bleeding peptic ulcer. Forty two patients with haemorrhage from peptic ulcers with visible vessels were enrolled in a randomised study comparing endoscopic haemostasis with adrenaline (1:10,000) injections (adrenaline group) and adrenaline injection + neodymium yttrium-aluminium-garnet (Nd:YAG) laser photocoagulation (adrenaline + laser group). The two groups (21 patients each) were well matched for factors affecting outcome. Surgery was performed for continued haemorrhage uncontrolled by endoscopic treatment or rebleeding after two endoscopic treatments. Haemostasis after one treatment was similar in the two groups: adrenaline 16/21 (76%), adrenaline + laser 18/21 (86%). Haemostasis after two treatments was numerically (0.05 less than p less than 0.10) greater in the adrenaline + laser group: 21/21 (100%) v 18/21 (86%). Three patients (14%) in the adrenaline group underwent uneventful emergency surgery. There were no deaths or procedure related complications in either group. Most bleeds from peptic ulcers with visible vessels can be controlled endoscopically without the need for surgery. Both treatments in this study proved highly efficacious in securing haemostasis. Adrenaline injection treatment seems to be the treatment of choice in view of its simplicity, low cost, and availability. Additional Nd:YAG laser treatment may provide a marginal improvement in efficacy, although a much larger trial would be required to prove this. To compare endoscopic adrenaline injection alone and adrenaline injection plus heat probe for the treatment of actively bleeding peptic ulcers.
                Randomised prospective study of patients admitted with actively bleeding peptic ulcers.
                One university hospital.
                276 patients with actively bleeding ulcers detected by endoscopy within 24 hours of admission: 136 patients were randomised to endoscopic adrenaline injection alone and 140 to adrenaline injection plus heat probe treatment.
                Initial endoscopic haemostasis; clinical rebleeding; requirement for operation; requirement for blood transfusion; hospital stay, ulcer healing at four weeks; and mortality in hospital.
                Initial haemostasis was achieved in 131/134 patients (98%) who received adrenaline injection alone and 135/136 patients (99%) who received additional heat probe treatment (P = 0.33). Outcome as measured by clinical rebleeding (12 v 5), requirement for emergency operation (14 v 8), blood transfusion (2 v 3 units), hospital stay (4 v 4 days), ulcer healing at four weeks (79.1% v 74%), and in hospital mortality (7 v 8) were not significantly different in the two groups. In the subgroup of patients with spurting haemorrhage 8/27 (29.6%; 14.5% to 50.3%) patients from the adrenaline injection alone group and 2/31 (6.5%; 1.1% to 22.9%) patients from the dual treatment group required operative intervention. The relative risk of this was lower in the dual treatment group (0.17; 0.03 to 0.87). Hospital stay was significantly shorter in the dual treatment group than the adrenaline injection alone group (4 v 6 days, P = 0.01).
                The addition of heat probe treatment after endoscopic adrenaline injection confers an advantage in ulcers with spurting haemorrhage. Endoscopic injection therapy improves outcome in bleeding peptic ulcer, but the optimum regimen is unknown. The aim of this study was to compare the efficacy of endoscopic therapy with dilute adrenaline alone vs. adrenaline plus human thrombin in the treatment of patients with major peptic ulcer hemorrhage.
                One hundred forty patients with significant peptic ulcer hemorrhage and active arterial bleeding or a nonbleeding visible vessel were randomized to endoscopic injection with 1:100,000 adrenaline (70 patients; group 1) or to adrenaline plus 600-1000 IU of human thrombin (70 patients; group 2). The two groups were well matched for age, shock, hemoglobin concentration, comorbid disease, endoscopic findings, and consumption of nonsteroidal anti-inflammatory drugs.
                Fourteen patients from group 1 (20%) and 3 patients from group 2 (4.5%) rebled (P < 0.005). Seven patients from group 1 (10%) but no patients from group 2 died within 30 days of admission (P < 0.013). Patients from group 1 were administered a total of 297 units of blood compared with 219 units in group 2 (P < 0.041).
                Endoscopic injection using adrenaline plus human thrombin is superior to injection with dilute adrenaline alone and may represent the best treatment for bleeding peptic ulcers. Peptic ulcer bleeding remains a disease with considerable morbidity and mortality. Epinephrine is the most widely used endoscopic injection agent, but bleeding recurs in 20% of high-risk cases. Fibrin glue might be an ideal injection agent, based on its physiologic properties, despite its demanding injection technique and high cost. The aim of this study was to determine whether the injection of fibrin glue in combination with epinephrine improves outcome for patients at high risk of recurrent bleeding.
                Patients were prospectively randomized to injection of epinephrine alone (n = 70) or epinephrine plus fibrin glue (n = 65). Endoscopy was repeated daily until the ulcer base was clean. All patients were treated with high-dose omeprazole.
                Initial hemostasis was 100% in both groups. There was no significant overall difference in rates of recurrent bleeding (24.3% and 21.5%, respectively, for epinephrine and epinephrine plus fibrin). When patients were stratified according to Forrest criteria, no significant difference could be found, although there was a trend toward less recurrent bleeding after fibrin injection of actively bleeding ulcers. There was no significant difference in the proportions of patients who required surgery (10% and 6%, respectively, for epinephrine and epinephrine plus fibrin). Mortality was the same (3%) in each group.
                Adding fibrin glue to epinephrine for injection treatment of bleeding peptic ulcers does not improve outcome. Fibrin glue might be of some value in selected cases.
Additional endoscopic treatment after epinephrine injection reduces further bleeding and the need for surgery in patients with high bleeding peptic ulcer.