Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery
Condition: Schistosomiasis Mansoni; Portal Hypertension; Upper Gastrointestinal Bleeding
MeSH terms: Schistosomiasis; Schistosomiasis mansoni; Hypertension, Portal; Gastrointestinal Hemorrhage; Hypertension
Study type: Interventional

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.
    

Intervention name(s): Endoscopic treatment; Total EGDS+ endoscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Schistosomiasis; Surgical treatment; Endoscopic treatment