Clinical trial NCT01931826: Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery
Official title: Treatment of Schistosomal Portal Hypertension: Assessment of Efficacy of Endoscopic Therapy Alone or in the Combined With Surgical Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schistosomiasis Mansoni
Portal Hypertension
Upper Gastrointestinal Bleeding
Keywords: Schistosomiasis
Surgical treatment
Endoscopic treatment
Lead sponsor: Universidade Estadual de Ciências da Saúde de Alagoas
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 54
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

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 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.

Primary outcomes:
measure: Sucess of treatment evaluated clinically by the absence of UGIB in the two years o follow-up.
timeFrame: 24 months
Secondary outcomes:
measure: Endoscopic evaluation of presence and grade of esophageal varices were made in both groups during the follow-up.
timeFrame: 24 months
Other outcomes:
measure: No other outcomes were evaluated.
timeFrame: 24 months
Locations:
city: Maceio
country: Brazil
facility: Universidade Federal de Alagoas
state: Alagoas
Study officials:
affiliation: Universidade Estadual de Ciências da Saúde de Alagoas
name: Celina Lacet, Doctor
role: PRINCIPAL_INVESTIGATOR
References: