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PubMedDate not supplied

A prospective randomized study of two sclerotherapy techniques for esophageal varices.

In a study designed to compare the efficacy and safety of two techniques of injection sclerotherapy, 40 patients (30 with cirrhosis and 10 with portal vein block) were randomly allocated to the sheath or free-hand technique. Although the former was associated with significantly less bleeding within the first 24 hr of injection (p less than 0.05) but more postinjection pain (p less than 0.05) and esophageal stricture, there was a trend toward earlier obliteration of varices. This was most marked over the first three courses of injection, and although frequency of rebleeding was not significantly less, none of the 11 episodes in the sheath group were fatal, compared to 5 of 15 bleeds in those injected by the free-hand technique (p less than 0.05).

Clinical Trials as Topic↗
PubMedDate not supplied

Sclerotherapy of esophageal varices: an endoscopic and portographic study.

A prospective series of 26 patients with portal hypertension and recent bleeding from esophageal varices was investigated with percutaneous transhepatic selective portography (PTP). PTP was performed immediately prior to and, in 23 patients, just after the initial endoscopic injection sclerotherapy (ST) session to study the acute effects of ST on the mediastinal portal-systemic collaterals. Late follow-up PTP was performed after a median of 8 months in 21 of 26 patients considered endoscopically to be free from esophageal varices after a median of 6 ST sessions. Five patients rebled from esophageal or gastric varices during the follow-up period of 15 months, but there were no fatalities due to variceal hemorrhage. In all patients, the initial PTP showed portal-systemic mediastinal collaterals. Immediately after ST, it was not possible to opacify esophageal varices at all (10 patients) or only partially (7 patients). Five patients died prior to late follow-up PTP. Endoscopic judgment of complete eradication of esophageal varices after repeated ST was in agreement with the late PTP results in 18 of 21 patients. In one patient, PTP showed residual esophageal varices subsequently confirmed by endoscopy. The results were uncertain in two patients for technical reasons. This study supports the opinion that submucosal esophageal varicose veins, as visualized by PTP, can be efficiently eradicated by serial ST, leaving the other mediastinal collaterals unaffected.

Endoscopy↗
PubMedDate not supplied

Spinal cord paralysis following sclerotherapy for esophageal varices.

A child with cryptogenic cirrhosis underwent a third session of elective sclerotherapy. Endoscopic therapy consisted of intravascular injection of ethanolamine oleate in varices newly developed at the midesophagus level. Irreversible paraplegia was documented within 8 hr postoperatively. Two years later she eventually died from gastrointestinal bleeding. Autopsy findings were compatible with an infarct of the spinal cord secondary to an occlusion of the anterior spinal artery. Various hypotheses which might explain the passage of the sclerosing material from the esophagus to the anterior spinal artery include: arterial occlusion secondary to venous thrombosis and spinal cord necrosis, accidental injection in an intercostal artery or azygous vein through the esophageal wall, the presence of a congenital arteriovenous fistula or the opening of arteriovenous shunt. Paravasal injection of dilute sclerosing agent might protect against this unusual but dramatic complication.

Arteries↗
PubMedDate not supplied

Endoscopic sclerosis and esophageal balloon tamponade in acute hemorrhage from esophagogastric varices: a prospective controlled randomized trial.

A prospective randomized controlled clinical trial was performed in 43 consecutive histologically proved cirrhotic patients with endoscopically proved actively bleeding esophageal varices. Twenty-two were randomly selected to have esophageal tamponade with the Sengstaken-Blakemore tube, and 21 were selected to have endoscopic sclerosis of the esophageal wall. The two groups were similar in demographic, clinical and laboratory data. Bleeding was controlled by the Sengstaken-Blakemore tube in 16 of 22 patients (73%) and by endoscopic sclerosis in 20 of 21 (95%). Among those controlled by the Sengstaken-Blakemore tube, seven (44%) rebled and three (43%) were again controlled by the Sengstaken-Blakemore tube; in the endoscopic sclerosis group, four (20%) rebled and three (75%) were controlled. Thus, hemorrhage was definitively controlled in 52% of patients and 66% of bleeding episodes in the Sengstaken-Blakemore tube group and in 90% of patients and 92% of bleeding episodes in the endoscopic sclerosis group. The definite control of hemorrhage was significantly better in the endoscopic sclerosis group (p less than 0.01). The Sengstaken-Blakemore tube patients received no definitive therapy after bleeding had been controlled. Within 30 days, six patients (27%) in the Sengstaken-Blakemore tube group had died compared to 2 (10%) in the endoscopic sclerosis group which is statistically significant (p less than 0.01) in favor of endoscopic sclerosis. The frequency of complications was similar in the two groups. Endoscopic sclerosis patients received serial endoscopic sclerosis after bleeding had been stopped during the whole period of follow-up.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Trials as Topic↗
PubMedDate not supplied

A prospective, randomized controlled trial of chronic esophageal variceal sclerotherapy.

The results of a prospective, randomized controlled trial of chronic esophageal variceal sclerotherapy conducted over a 38-month period are presented. One-hundred twenty patients were randomized following variceal bleeding, 63 to esophageal variceal sclerotherapy and 57 to control. Mean follow-up was similar in both groups (esophageal variceal sclerotherapy, 12.5 +/- 8.8 months; control, 14.9 +/- 6.6 months). Twenty-one percent of the patients in each group were lost to follow-up. Esophageal variceal sclerotherapy decreased rebleeding as evidenced by a decrease in the mean bleeding risk factor, transfusion requirement and by an increase in bleeding free interval; differences between the treated and control groups in these parameters were especially significant after variceal obliteration. A high incidence of asymptomatic ulceration and low frequency of strictures were notable effects of esophageal variceal sclerotherapy. Cumulative life table analysis revealed no differences in survival between esophageal variceal sclerotherapy and control groups. However, when patients who received portal-systemic shunt surgery (esophageal variceal sclerotherapy, 6%; control, 28%) were removed from the analysis at the time the shunt surgery was performed (defining the shunt as an endpoint, a significant difference in survival (p less than 0.05, F ratios) in favor of esophageal variceal sclerotherapy was observed.

Adult↗
PubMedDate not supplied

Improved survival following injection sclerotherapy for esophageal varices: final analysis of a controlled trial.

Long-term follow-up (median: 37 months; range: 19 to 68) of the 116 patients (56 sclerotherapy, 60 control group) entered into a controlled trial of endoscopic variceal sclerotherapy has shown a total of 18 deaths in the sclerotherapy group, including five from variceal bleeding compared with 32 deaths in the control group (p less than 0.01), of which 25 were from variceal hemorrhage (p less than 0.001). Survival as assessed by cumulative life analysis was significantly better in those treated by sclerotherapy (p less than 0.001). Both the cumulative proportion of patients rebleeding and the total number of episodes of variceal hemorrhage were also significantly less in the sclerotherapy group (p less than 0.01). Recurrence of varices was observed in 27 of 45 patients in whom variceal obliteration was initially observed at a median of 11 months (range: 2 to 27) later, although in only 12 of these did bleeding recur and was the cause of death in one.

Adolescent↗
PubMedDate not supplied

Noninvasive measurement of the pressure of esophageal varices using an endoscopic gauge: comparison with measurements by variceal puncture in patients undergoing endoscopic sclerotherapy.

Measurements of variceal pressure with a noninvasive endoscopic pressure gauge and by direct variceal puncture were performed in 20 cirrhotic patients with portal hypertension in the course of the first session of therapeutic sclerotherapy following an episode of variceal bleeding. Endoscopic gauge measurements of the pressure of esophageal varices gave similar values (15.5 +/- 2.7 mm Hg) than measurements by variceal puncture (15.4 +/- 2.4 mm Hg; not statistically significant), and there was a highly significant linear correlation between both measurements (r = 0.9, p less than 0.001). Azygos blood flow, that was markedly increased in these patients (852 +/- 399 ml per min), was directly related to variceal pressure (r = 0.73, p less than 0.01). Variceal pressure was significantly lower than portal pressure (18.8 +/- 5.0 mm Hg) (p less than 0.05), indicating that measurements of variceal pressure cannot substitute measurements of portal pressure. The study demonstrates that the noninvasive endoscopic gauge technique allows an accurate estimation of variceal pressure in patients with portal hypertension. This technique may provide additional useful information in the evaluation of portal hypertension as well as on the mechanism of variceal bleeding.

Adult↗
PubMedDate not supplied

Use of propranolol to reduce the rebleeding rate during injection sclerotherapy prior to variceal obliteration.

In a prospective, randomized controlled trial, 53 patients with variceal hemorrhage from portal hypertension, including 44 with cirrhosis, were allocated, after initial control of the bleeding, to treatment by sclerotherapy alone, or by this together with oral propranolol in a dose sufficient to reduce resting pulse rate by 25% during the period up to the time when varices were obliterated. Eight of the 27 patients undergoing sclerotherapy alone rebled during this period as compared to 7 of the 26 patients in the additional propranolol group (p greater than 0.80), two patients from each group dying from uncontrollable variceal hemorrhage. Propranolol precipitated encephalopathy in one patient and complicated resuscitation following bleeding in a second, and as there was no evidence in this study that use of the drug reduced the frequency or severity of the variceal bleeding, its administration cannot be recommended during the period prior to obliteration of varices by sclerotherapy.

Clinical Trials as Topic↗
PubMedDate not supplied

Prevention of recurrent bleeding in cirrhotics with recent variceal hemorrhage: prospective, randomized comparison of propranolol and sclerotherapy.

To compare the efficacy of endoscopic paravariceal sclerotherapy and oral propranolol in the prevention of recurrent upper gastrointestinal bleeding, 78 cirrhotic patients were randomly assigned to either treatment after an endoscopically proven bleed from esophageal varices. After randomization, but before treatment had been started, a total of eight patients had to be withdrawn from the study due to early rebleeding (requiring emergency sclerotherapy) or violations of the protocol. Among the 70 patients analyzed (36 sclerotherapy, 34 propranolol), both treatment groups were comparable with respect to demographic, clinical and laboratory data. The groups also did not differ with respect to continued alcohol intake. Sclerotherapy was performed twice weekly using 1% polidocanol as the sclerosing agent until the varices were eradicated or well-covered by fibrous tissue. Propranolol was given twice daily at a dose reducing the resting heart rate by 25% (60 to 320 mg per day; mean +/- SD = 161 +/- 80 mg per day). Patients were followed for up to 2 years with visits at 3 monthly intervals (mean follow-up = sclerotherapy, 14 months; propranolol, 9.2 months). Life table analysis of patients without rebleeding from nonvariceal sites revealed a tendency in favor of propranolol; however, the difference did not reach statistical significance. No significant difference was observed between sclerotherapy and propranolol in the proportion of patients rebleeding from esophageal varices or from all sources of upper gastrointestinal bleeding. Furthermore, survival was similar in both treatment groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMedDate not supplied

Sclerotherapy vs. distal splenorenal shunt in the elective treatment of variceal hemorrhage: a randomized controlled trial.

One hundred and twelve consecutive Child Class A and B cirrhotic patients were included in a prospective controlled trial aimed at investigating the efficacy and safety of endoscopic sclerotherapy vs. distal splenorenal shunt in the elective treatment of hemorrhage from esophagogastric varices. Fifty-seven patients were randomly allocated to splenorenal shunt and 55 to endoscopic sclerotherapy. Since only 4 of the 55 patients assigned to endoscopic sclerotherapy had to be excluded after randomization and before treatment as compared to 14 of the 57 patients assigned to splenorenal shunt, it is suggested that the applicability of endoscopic sclerotherapy is greater than that of splenorenal shunt. One patient in each group died within 30 days of the procedure and two in the endoscopic sclerotherapy group were lost to follow-up just after discharge. Variceal rebleeding during follow-up occurred in 37.5% (18/48) of patients in the endoscopic sclerotherapy group and in 14.3% of those in the splenorenal shunt group (6/42) (p less than 0.02), whereas hepatic encephalopathy was more frequent in patients submitted to splenorenal shunt (10/42, 24%) than in those treated by endoscopic sclerotherapy (4/48, 8%) (p less than 0.05). The therapeutic modality was the only variable with independent predictive value for rebleeding during follow-up, whereas for hepatic encephalopathy, the therapeutic modality, and the presence of encephalopathy related to the bleeding episode each showed independent predictive value. Early and long-term mortality, did not differ between the two therapeutic groups, being the 2-year survival was 71% for splenorenal shunt and 68% for endoscopic sclerotherapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Trials as Topic↗
PubMedDate not supplied

Prevention of recurrence of esophageal varices after endoscopic injection sclerotherapy with ethanolamine oleate.

Endoscopic injection sclerotherapy was given to 155 patients with esophageal varices mainly related to non-alcoholic liver cirrhosis. The formation of a superficial ulcer in the lower esophagus was achieved in 141 (91.0%) of the 155 patients, with an average of 4.1 sessions of endoscopic injection sclerotherapy during an average time of 4.9 weeks. The average volume of 5% ethanolamine oleate sclerosant used was 24.8, 19.2, 12.3 and 6.5 ml for the initial to fourth sessions of endoscopic injection sclerotherapy, respectively. For 14 patients, a sufficient number of sessions of endoscopic injection sclerotherapy could not be given: 10 early deaths (5 hepatoma, 4 liver failure and 1 gastric bleeding), and 4 refused further sessions. When the esophageal mucosa had been eliminated and a superficial ulcer had formed, episodes of recurrent bleeding or recurrence of esophageal varices were nil over a median follow-up of 14.6 months, with a range of 1 to 27 months. In seven patients, bleeding recurred before elimination of the mucosa could be achieved, but these bleeding episodes were well controlled with an additional session of endoscopic injection sclerotherapy. At the time of analysis, there were 36 deaths (20 hepatoma, 14 liver failure and 2 gastric bleeding) among these 155 patients. Thus, the mean follow-up was 16.3 months (range: 7 to 27 months) in the 119 survivors, with no recurrence of the varices. We propose that removal of the esophageal mucosa may well be the endpoint of repeated endoscopic injection sclerotherapy in the management of patients on injection sclerotherapy.

Endoscopy↗
PubMedDate not supplied

Prophylactic sclerotherapy of high-risk esophageal varices: results of a multicentric prospective controlled trial.

In this prospective, multicenter trial, 140 cirrhotic patients with no previous upper gastrointestinal bleeding and with esophageal varices endoscopically judged to be at high risk of hemorrhage were randomized to receive either sclerotherapy or conservative treatment for the prevention of first variceal bleeding. The end-points of the study were bleeding and death. Life table curves showed that prophylactic sclerotherapy significantly diminished the incidence of variceal hemorrhage (p less than 0.001) and overall mortality (p less than 0.01). Two-year cumulative bleeding rate was 18% in the sclerosis group (95% confidence interval = 10 and 31) and 57% (95% confidence interval = 40 and 72) in the control group. Two-year cumulative mortality rate was 30% (95% confidence interval = 19 and 45) in the sclerotherapy group and 56% (95% confidence interval = 39 and 72) in the controls. One patient died after hemorrhage from an ulcer secondary to sclerotherapy. Analysis by the Cox model of the factors potentially confounding or interacting with the effect of sclerotherapy suggested that sclerotherapy was more efficient in preventing first bleeding in patients with decompensated disease (Child B and C) than in those in good condition (Child A). However, the 2-year cumulative bleeding rate of untreated Child A patients was only 19%, showing how in this group the endoscopic findings were unreliable in selecting high-risk varices and explaining why after a 2-year follow-up prophylactic sclerosis did not show any benefit in such patients. We conclude that sclerotherapy can decrease the incidence of first variceal bleeding and death for a period of 2 years in cirrhotic patients with high-risk varices.

Adult↗
PubMed1989

Controlled clinical trial of injection sclerotherapy for active variceal bleeding.

In a prospective, randomized clinical trial, immediate injection sclerotherapy was compared with treatment by a combined infusion of vasopressin (0.4 unit per min) and nitroglycerin (40 to 400 micrograms per min) in 50 consecutive patients with 64 episodes of endoscopy-proven variceal hemorrhage. Control of bleeding was assessed over a 12-hr period following entry into the trial. Patients in the vasopressin + nitroglycerin group were then treated by sclerotherapy, as were those in the sclerotherapy group who continued to bleed. At 12 hr, bleeding was controlled in 29 (88%) of the 33 episodes treated by sclerotherapy compared with 20 (65%) of 31 episodes treated by vasopressin + nitroglycerin (p less than 0.05). Recurrence of variceal bleeding occurred at the same frequency (31%). Although admission mortality was less in those initially treated by sclerotherapy compared to those managed by vasopressin + nitroglycerin, this did not reach statistical significance (27 and 39%, respectively, p greater than 0.20). Sclerotherapy carried out as the first treatment of the active variceal hemorrhage proved both safe and effective, even in the presence of major hemorrhage, and as compared to combined vasopressin and nitroglycerin it proved superior.

Clinical Trials as Topic↗
PubMed1989

Sucralfate for the prevention of early rebleeding following injection sclerotherapy for esophageal varices.

One hundred eighty patients with variceal bleeding and treated by long-term sclerotherapy were randomized into a prospective randomized controlled clinical trial to assess the efficacy of sucralfate in reducing the frequency of rebleeding from esophageal ulceration prior to variceal obliteration. Overall, 29 (32%) of the 92 patients treated with the addition of sucralfate rebled, compared to 37 (42%) of 88 patients managed by sclerotherapy alone (p less than 0.10), but when patients with well-compensated liver disease were considered, the respective figures were 14 (24%) and 25 (42%)--a statistically significant difference (p less than 0.05). The frequency (approximately 70%), number (per patient) and extent of sclerotherapy-induced esophageal mucosal ulceration were not different for the two groups, although proven rebleeding from the ulceration occurred less frequently in those receiving sucralfate (10 and 20 occasions, respectively, p less than 0.05). Mortality was not different for the two groups. Thus, use of sucralfate will reduce the frequency of rebleeding during long-term treatment by sclerotherapy, although benefit appears to be restricted to well-compensated patients and without an endoscopic overt effect upon esophageal mucosal ulceration.

Combined Modality Therapy↗