Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery

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

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).

Study Overview

• Status: Completed
• Conditions: Portal Hypertension; Upper Gastrointestinal Bleeding; Schistosomiasis Mansoni
• Intervention / Treatment: Procedure: Endoscopic treatment; Procedure: Total EGDS+ endoscopy

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Alagoas
    • Maceio, Alagoas, Brazil, 57000000
      • Universidade Federal de Alagoas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
No other outcomes were evaluated.	24 months

Collaborators and Investigators

• Sponsor: Universidade Estadual de Ciências da Saúde de Alagoas
• Investigators: Principal Investigator: Celina Lacet, Doctor, Universidade Estadual de Ciências da Saúde de Alagoas

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): March 1, 2005
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: March 15, 2013
• First Submitted That Met QC Criteria: August 26, 2013
• First Posted (Estimate): August 29, 2013

Study Record Updates

• Last Update Posted (Estimate): August 29, 2013
• Last Update Submitted That Met QC Criteria: August 26, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Endoscopic treatment; Schistosomiasis; Surgical treatment
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Infections; Gastrointestinal Diseases; Hemorrhage; Liver Diseases; Vector Borne Diseases; Parasitic Diseases; Helminthiasis; Trematode Infections; Hypertension; Hypertension, Portal; Gastrointestinal Hemorrhage; Schistosomiasis; Schistosomiasis mansoni
• Other Study ID Numbers: UNCISAL-2012-Treatment PHS