Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery

NCT01931826 | Completed

• 1 other identifier: UNCISAL-2012-Treatment PHS
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Schistosomiasis Mansoni; Portal Hypertension; Upper Gastrointestinal Bleeding

Keywords

Schistosomiasis; Surgical treatment; Endoscopic treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Endoscopic evaluation of presence and grade of esophageal varices were made in both groups during the follow-up.

  24 months

Other Outcomes (1)

• No other outcomes were evaluated.

  24 months

Study Arms (2)

Endoscopic treatment alone

ACTIVE COMPARATOR

3 to 5 sessions of sclerotherapy till eradication of esophageal varices.

Procedure: Endoscopic treatment

Total EGDS + endoscopy

ACTIVE COMPARATOR

Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively.

Procedure: Endoscopic treatment; Procedure: Total EGDS+ endoscopy

Interventions

Endoscopic treatment PROCEDURE

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.

Endoscopic treatment alone; Total EGDS + endoscopy

Total EGDS+ endoscopy PROCEDURE

Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively.

Total EGDS + endoscopy

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Chronic alcoholism, defined as an alcohol intake of ≥60 g/EtOH/day in men and ≥40 g/EtOH/day in women;
• presence of fundal varices on endoscopy.

Sponsors & Collaborators

• Universidade Estadual de Ciências da Saúde de Alagoas: lead

Study Sites (1)

Universidade Federal de Alagoas

Maceió, Alagoas, 57000000, Brazil

Location

MeSH Terms

Conditions

Schistosomiasis mansoni; Hypertension, Portal; Gastrointestinal Hemorrhage; Schistosomiasis

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases; Liver Diseases; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Celina Lacet, Doctor

  Universidade Estadual de Ciências da Saúde de Alagoas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: August 29, 2013
• Study Start: January 1, 2003
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2009
• Last Updated: August 29, 2013

Record last verified: 2013-08

Locations

BR (1)