Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery
NCT ID: NCT01931826
Last Updated: 2013-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2003-01-31
2009-03-31
Brief Summary
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Detailed Description
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Over a two-year period, 79 patients were recruited for elective treatment of SPH. The criteria for selection were: a) an established diagnosis of hepatosplenic schistosomiasis as the cause of portal hypertension; b) a history of UGIB secondary to rupture of esophageal varices, with at least 20 days having elapsed since the most recent episode of bleeding; and c) age between 15 and 65 years.
The exclusion criteria were: chronic alcoholism, defined as an alcohol intake of ≥60 g/EtOH/day in men and ≥40 g/EtOH/day in women; evidence of decompensated liver disease of mixed etiology or of any chronic disease that contraindicated surgery were considered absolute exclusion criteria; the relative criteria for exclusion were altered hemostasis (platelet count \< 50×109/L or INR \> 1.5); presence of fundal varices on endoscopy.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Endoscopic treatment alone
3 to 5 sessions of sclerotherapy till eradication of esophageal varices.
Endoscopic treatment
The presence of gastroesophageal varices was confirmed by fiberoptic esophagogastroduodenoscopy (EGD). In view of the experience of our service and local circumstances at the time of the study, the endoscopic treatment of choice was sclerotherapy, performed with a Teflon-sheathed metal needle. The sclerosing agent was 2.5% monoethanolamine oleate. Esophageal varices visible on EGD in the pre- and post-treatment period were classified as small, medium or large on the basis of criteria proposed by Paquet. All complications attributable to sclerotherapy were recorded.
Total EGDS + endoscopy
Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively.
Endoscopic treatment
The presence of gastroesophageal varices was confirmed by fiberoptic esophagogastroduodenoscopy (EGD). In view of the experience of our service and local circumstances at the time of the study, the endoscopic treatment of choice was sclerotherapy, performed with a Teflon-sheathed metal needle. The sclerosing agent was 2.5% monoethanolamine oleate. Esophageal varices visible on EGD in the pre- and post-treatment period were classified as small, medium or large on the basis of criteria proposed by Paquet. All complications attributable to sclerotherapy were recorded.
Total EGDS+ endoscopy
Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively.
Interventions
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Endoscopic treatment
The presence of gastroesophageal varices was confirmed by fiberoptic esophagogastroduodenoscopy (EGD). In view of the experience of our service and local circumstances at the time of the study, the endoscopic treatment of choice was sclerotherapy, performed with a Teflon-sheathed metal needle. The sclerosing agent was 2.5% monoethanolamine oleate. Esophageal varices visible on EGD in the pre- and post-treatment period were classified as small, medium or large on the basis of criteria proposed by Paquet. All complications attributable to sclerotherapy were recorded.
Total EGDS+ endoscopy
Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively.
Eligibility Criteria
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Inclusion Criteria
* an established diagnosis of hepatosplenic schistosomiasis as the cause of portal hypertension;
* a history of UGIB secondary to rupture of esophageal varices, with at least 20 days having elapsed since the most recent episode of bleeding.
Exclusion Criteria
* the relative criteria for exclusion were altered hemostasis (platelet count \< 50×109/L or INR \> 1.5);
* presence of fundal varices on endoscopy.
15 Years
65 Years
ALL
No
Sponsors
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Universidade Estadual de Ciências da Saúde de Alagoas
OTHER
Responsible Party
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Celina Maria Costa Lacet
Doctor
Principal Investigators
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Celina Lacet, Doctor
Role: PRINCIPAL_INVESTIGATOR
Universidade Estadual de Ciências da Saúde de Alagoas
Locations
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Universidade Federal de Alagoas
Maceió, Alagoas, Brazil
Countries
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Other Identifiers
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UNCISAL-2012-Treatment PHS
Identifier Type: -
Identifier Source: org_study_id