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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

Page last updated: August 23, 2015

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