Randomized controlled trial of sclerotherapy versus somatostatin infusion in the prevention of early rebleeding following acute variceal hemorrhage in patients with cirrhosis. Variceal Bleeding Study Group.

BACKGROUND/AIMS: Early rebleeding is a very frequent complication of variceal hemorrhage. Sclerotherapy effectively controls variceal hemorrhage and prevents early rebleeding. Somatostatin infusion is as effective as sclerotherapy in controlling variceal hemorrhage, but no study has evaluated the efficacy of 5-day somatostatin infusion in preventing early rebleeding after the initial control of bleeding. The aim of the study was to compare the efficacy and safety of somatostatin and sclerotherapy in the prevention of early variceal rebleeding in cirrhotic patients. METHODS: The study included 169 patients with acute variceal hemorrhage who were randomized within 24 h of controlling the acute bleeding to receive either sclerotherapy (n=79) or continuous somatostatin infusion for 5 days (250 microg/h after a 250-microg bolus, repeated every 24 h, n=90). Success of therapy was defined by absence of rebleeding during the 5 days following randomization. RESULTS: Early (5 days) rebleeding occurred in 12/79 patients treated with sclerotherapy vs 14/90 of those receiving somatostatin (NS). The treatment was equally effective in Child's C patients (sclerotherapy: 18/20; somatostatin: 17/20; NS) and Child's A+B patients (sclerotherapy: 49/59; somatostatin: 59/70; NS). Complications occurred in 19/79 patients receiving sclerotherapy vs 4/90 in the somatostatin group (p= 0.00019), being severe in 6 vs 0 patients (p=0.0094). There were no differences between the two groups in the incidence of 6-week rebleeding (14% vs 15%, NS) and mortality (9% vs 9%). CONCLUSIONS: Continuous somatostatin infusion is as effective as sclerotherapy in preventing early variceal rebleeding and maintaining low mortality following acute variceal hemorrhage. Somatostatin is associated with a lower rate of complications than sclerotherapy.

[Upper gastrointestinal tract hemorrhage: syndromic diagnosis at a hospital emergency unit]. / Hemorragia digestiva alta: diagnóstico sindrómico en el servicio de urgencias de un hospital.

BACKGROUND: To analyze the assistance requirements generated in a hospital emergency unit by the upper gastrointestinal bleeding (UGIB) syndrome, and to assess some strategies intended to improve its syndromic diagnosis prior to admission. PATIENTS AND METHODS: Prospective study of a cohort including 1,029 consecutive cases assisted because of presumed hematemesis or melenas. At the emergency room UGIB was diagnosed or ruled out according to criteria based on examination of vomits and stools. Those cases not classified were observed before establishing the preadmission diagnosis. Sensitivity (Se), specificity (Sp) and likelihood ratio for a positive or negative test were estimated in each step of the process. The efficacy of the proposed criteria for diagnosis was compared with those accepted by the World Organization of Gastroenterology (WOG). The diagnosis at hospital discharge was used a reference pattern. RESULTS: A final diagnosis of UGIB was established in 718 cases (59%). The emergency room criteria were applied to 848 out of the 1,029 patients assisted, bleeding being discarded in 216 cases (Se = 0.43; Sp = 0.99) and estimated as present in 632 (Se = 0.79%; Sp = 0.87%). By combining these results with those obtained after observation of the remaining 361 patients, the preadmission diagnosis showed a sensitivity of 0.99% and a specificity of 0.86%. Should the WOG criteria were adopted, the same process was equally sensitive but less specific (Sp = 0.55%). CONCLUSIONS: In a high proportion of patients assisted in a hospital for a suspected UGIB, this diagnosis is not confirmed. The examination of vomits and stools by nursing or medical staff, followed if needed by an observation period, improves the accuracy of the syndromic diagnosis prior to admission and may avoid an elevated number of unnecessary hospital staying.

[Gastric emptying as an etiopathogenic factor in gastroesophageal reflux disease]. / Estudio de la evacuación gástrica como factor etiopatogénico de la enfermedad por reflujo gastroesofágico.

The aim of this study is to evaluate gastric emptying change in patients with gastroesophageal reflux (GER). To this purpose, 36 patients with GER diagnosis and 18 control subjects have been studied. GER diagnosis was achieved by means of endoscopy, biopsy and 24 h continuous pH monitoring. Gastric emptying studies were performed on a two day basis, similar labelling meals were provided to patients and control subjects. Those consisted in a one-egg omelette, chicken (110 gr) and orange juice (200 ml). On first day liquid phase was labelled with 99mTc-diethylenetriamine pentaacetic acid (99mTc-DTPA), and on second day, the solid phase was labelled with 99mTc-sulfur colloid in the omelette (Labelling efficiency was 85.3 +/- 3.2%). The studies were carried out by imaging static anterior and posterior views every 20 minutes for a total of 180 minutes. Images were quantified obtaining solid and liquid gastric emptying curves. No statistical significative difference between patients and control subjects gastric emptying results were found. We can conclude that gastric emptying is not a main factor in the pathogenesis of gastroesophageal reflux.

Prediction of further hemorrhage in bleeding peptic ulcer.

OBJECTIVE: To obtain a simple mathematical model able to estimate early the risk of further hemorrhage in bleeding peptic ulcer. METHODS: A prospective study was conducted on 1567 patients admitted for acutely bleeding peptic ulcer. Ten readily available variables were tested for association with further hemorrhage, and then a logistic regression analysis was carried out. RESULTS: Further hemorrhage occurred in 312 (20%) patients. The univariate analyses showed age over 65 yr, male sex, alcoholism, associated disease, hematemesis, endoscopic bleeding stigmata and shock, and blood urea over 90 mg/dl at admission to be significantly associated with continuous hemorrhage or rebleeding (p < 0.05 to p < 0.001). When these were assessed in a multivariate logistic regression analysis, the best fitted model (likelihood ratio test = 9.9; p = 0.5) included four independent variables. Bleeding stigmata (p < 0.001; odds ratio = 3.1), shock (p < 0.001, odds ratio = 2.5), hematemesis (p < 0.001; odds ratio = 1.6) and age over 65 (p = 0.04); odds ratio = 1.3) were associated with high risk of further hemorrhage. CONCLUSIONS: Bleeding stigmata and changes in hemodynamics are confirmed as the most relevant predictors of further hemorrhage. When they are considered with hematemesis and age altogether, other clinical features loss importance for prognosis. By taking advantage of the joint influences of these variables, accuracy of prognosis improves with respect to that obtained when they are considered as individual risk factors.

Efficacy of the heater probe in peptic ulcer with a non-bleeding visible vessel. A controlled, randomised study.

A controlled, randomised study was performed to evaluate the efficacy of treatment with heater probe in the prevention of rebleeding from peptic ulcer with a non-bleeding visible vessel. One hundred and one patients were randomised into two groups: patients to be treated by heater probe (n = 51) and controls without active treatment (n = 50). In the heater probe group rebleeding occurred in five patients (10%) v 13 (26%) in the control group (p = 0.03), with a comparative risk of 0.38 in favour of the heater probe group. The difference in proportions of successful treatment for each group was 16.2% in favour of the heater probe (95% CI = 2 to 31%). Haemorrhage directly related to heater probe treatment occurred in four patients. In three of them bleeding was easily controlled by further heater probe pulses. There were no other complications and no death in the heater probe group. One patient in the control group died of pulmonary embolism. No significant differences in the length of stay in hospital, blood transfusions, surgical rates, or death were found; the design of the study, however, precluded an adequate assessment of these variables, because the heater probe was an optional rescue treatment when high surgical risk patients rebled. These results suggest that the heater probe is an effective and safe procedure in the prevention of recurrent haemorrhage in peptic ulcer with a non-bleeding visible vessel.

[The cost effectiveness of hemorrhage units]. / Rentabilidad de las unidades de sangrantes.

Gastrointestinal bleeding units appear as an alternative to intensive care units in the management of patients with gastrointestinal bleeding. Their hospitalization advantages and economic impact, however, are poorly evaluated. A survey was done among 176 Spanish general hospitals over 100 beds. Forty-four percent of the 176 hospitals answering the questionnaire had a protocol for the management of patients with gastrointestinal bleeding. Results from our survey show that gastrointestinal bleeding units are regarded as either useful (53%) or necessary (41%) by most hospitals, and should be equipped to provide intermediate-type care (88%). To the vast majority of hospitals, patient care is paramount to evaluate the yield of gastrointestinal bleeding units; in contrast, cost-efficiency analysis is relevant to only 31%, whereas the combination of cost efficiency and research is relevant to 61% of hospitals. Mean hospital charges for patients in our gastrointestinal bleeding unit, which has an occupancy rate of 95%, are 53% higher than those for regular inpatients, and 64% lower than those for patients in the intensive care unit.

[Digestive hemorrhage units. A national survey]. / Las unidades de hemorragias digestivas. Encuesta nacional.

The results of a national survey carried out on two hundred and five Spanish hospitals, on the treatment of upper gastrointestinal bleeding (UGIB) and special units for gastrointestinal haemorrhages, are reported in this paper. Questionnaires were sent to the chief of every Surgery, Gastroenterology and Internal Medicine Service. We received three hundred and twenty six answered questionnaires from 179 hospitals out of a total number of 582 mailed all over Spain. The Gastroenterology Units manage the UGIB in most hospitals, and in 45% of these, a protocol elaborated by gastroenterologists and surgeons is followed. In general, 94% of answers agree in the convenience or even need of Gastrointestinal Haemorrhage Units. However, when asked about this point in the setting of their own hospital, this figure comes down to 83%. On the other hand, only 46% consider the units to be warranted from the medical care and economical points of view. Most doctors think that to assess the yield of these units, medical care, economical and research criteria should be kept in mind. The general opinion is that should they exist in a given hospital, they should work as intermediate care units (87%), and be dependent of both Gastroenterology and Surgery units (71%). Currently, there are in Spain ten Gastrointestinal Haemorrhage Units, with a mean number of 6 beds, located in large hospitals, most of them run by the Gastroenterology Service. All of them are involved in some research project. In these units, overall mortality rates for UGIB, and mortality rate in bleeding peptic ulcers range close to 7% and 3%, respectively.

Somatostatin versus Sengstaken balloon tamponade for primary haemostasia of bleeding esophageal varices. A randomized pilot study.

In this study we evaluate the efficacy of somatostatin (ST) versus balloon tamponade (BT) in controlling bleeding from esophageal varices. Forty-four consecutive patients with active variceal bleeding were randomly assigned to treatment with a continuous infusion of ST at 250 micrograms/h after an initial bolus of 50 micrograms (group A) or to treatment with BT (group B). Five cases were excluded from the final analysis because of methodological issues. Nineteen patients were allocated to group A and twenty to group B. No differences in age, sex, alcohol intake, severity of bleeding or liver failure were found between the groups. Initial haemostasia within the first 4 h of treatment was obtained in 14 (74%) of the patients receiving ST and in 12 (60%) of those receiving BT. Three patients in group A and two in group B had early rebleeding. Bleeding was controlled over a 24-h period or until elective sclerotherapy could be performed in 11 (58%) and 10 (50%) of the patients, in groups A and B, respectively. One BT-treated patient developed aspiration pneumonia. No complications were observed in patients treated with ST. No significant differences in initial haemostasia, definite control of bleeding or complications were found between the two groups. In this study, somatostatin infusion was found to be as effective as Sengstaken BT in controlling acute variceal bleeding until an elective session of endoscopic sclerotherapy could be performed. However, larger studies are still needed to confirm this theory.