Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery

Not Applicable

Completed

• Conditions: Schistosomiasis Mansoni; Portal Hypertension; Upper Gastrointestinal Bleeding
• Interventions: Procedure: Endoscopic treatment; Procedure: Total EGDS+ endoscopy

• Registration Number: NCT01931826
• Lead Sponsor: Universidade Estadual de Ciências da Saúde de Alagoas

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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2005-03
• Study Completion: 2009-03
• Study First Submitted: 2013-03-15
• Status Verified: 2013-08
• Study First Submitted QC: 2013-08-26
• Last Update Submitted: 2013-08-26
• Study First Posted: 2013-08-29
• Last Update Posted: 2013-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic treatment alone	Endoscopic treatment	3 to 5 sessions of sclerotherapy till eradication of esophageal varices.
Total EGDS + endoscopy	Endoscopic treatment	Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively.
Total EGDS + endoscopy	Total EGDS+ endoscopy	Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively.

Primary Outcome Measures

Name	Time	Method
Sucess of treatment evaluated clinically by the absence of UGIB in the two years o follow-up.	24 months	Its purpose was to assess the efficacy of endoscopic treatment alone compared with the efficacy of sclerotherapy preceded by EGDS.

Secondary Outcome Measures

Name	Time	Method
Endoscopic evaluation of presence and grade of esophageal varices were made in both groups during the follow-up.	24 months

Trial Locations

Locations (1)

Universidade Federal de Alagoas; 🇧🇷 Maceio, Alagoas, Brazil