Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery
Information source: Universidade Estadual de Ciências da Saúde de Alagoas
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schistosomiasis Mansoni; Portal Hypertension; Upper Gastrointestinal Bleeding
Intervention: Endoscopic treatment (Procedure); Total EGDS+ endoscopy (Procedure)
Phase: N/A
Status: Completed
Sponsored by: Universidade Estadual de Ciências da Saúde de Alagoas Official(s) and/or principal investigator(s): Celina Lacet, Doctor, Principal Investigator, Affiliation: Universidade Estadual de Ciências da Saúde de Alagoas
Summary
Upper gastrointestinal bleeding (UGIB) is a major cause of morbidity and mortality in
patients with portal hypertension secondary to schistosomiasis mansoni. Taking into account
the endemic nature of schistosomiasis mansoni in our region and the high morbidity and
mortality directly associated with rupture of esophageal varices and UGIB in affected
patients, we conducted a prospective randomized trial in patients with schistosomiasis and a
history of bleeding esophageal varices. Its purpose was to assess the efficacy of endoscopic
treatment alone compared with the efficacy of sclerotherapy preceded by a surgical
treatment: Esophagogastric devascularization with splenectomy (EGDS).
Clinical Details
Official title: Treatment of Schistosomal Portal Hypertension: Assessment of Efficacy of Endoscopic Therapy Alone or in the Combined With Surgical Procedure
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Sucess of treatment evaluated clinically by the absence of UGIB in the two years o follow-up.
Secondary outcome: Endoscopic evaluation of presence and grade of esophageal varices were made in both groups during the follow-up.
Detailed description:
This was a prospective, randomized, single-center study carried out at the Department of
Clinical and Surgical Gastroenterology of Hospital Universitário Professor Alberto Antunes,
Universidade Federal de Alagoas (HU/UFAL). It was approved by the local Research Ethics
Committee (protocol #98/0039-3, code 4010000-6) and all patients provided written informed
consent prior to study enrollment. Patients who met relative criteria for exclusion received
the current standard of care and follow-up and were analyzed as a third group in the study.
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.
Eligibility
Minimum age: 15 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- age between 15 and 65 years;
- 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:
- 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.
Locations and Contacts
Universidade Federal de Alagoas, Maceio, Alagoas 57000000, Brazil
Additional Information
Starting date: January 2003
Last updated: August 26, 2013
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