Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Schistosomal Portal Hypertension: Assessment of Efficacy of Endoscopic Therapy Alone or in the Combined With Surgical Procedure

Conditions
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Schistosomiasis Mansoni, Portal Hypertension, Upper Gastrointestinal Bleeding

Intervention / Treatment
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* Procedure: Endoscopic treatment
* Procedure: Total EGDS+ endoscopy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endoscopic treatment alone<br>3 to 5 sessions of sclerotherapy till eradication of esophageal varices. | Procedure: Endoscopic treatment<br>* 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.<br>|
| Active Comparator: Total EGDS + endoscopy<br>Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively. | Procedure: Endoscopic treatment<br>* 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.<br>Procedure: Total EGDS+ endoscopy<br>* Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic evaluation of presence and grade of esophageal varices were made in both groups during the follow-up. |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schistosomiasis, Surgical treatment, Endoscopic treatment