Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery

Portal Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01931826
• Other study ID #: UNCISAL-2012-Treatment PHS
• Status: Completed
• Phase: N/A
• First received: March 15, 2013
• Last updated: August 26, 2013
• Start date: January 2003
• Est. completion date: March 2009

Study information

• Verified date: August 2013
• Source: Universidade Estadual de Ciências da Saúde de Alagoas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 2009
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hypertension
• Hypertension, Portal
• Portal Hypertension
• Schistosomiasis
• Schistosomiasis mansoni
• Upper Gastrointestinal Bleeding

Intervention

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.
• Total EGDS+ endoscopy
Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Alagoas	Maceio	Alagoas

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual de Ciências da Saúde de Alagoas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	No other outcomes were evaluated.		24 months	Yes
Primary	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	Yes
Secondary	Endoscopic evaluation of presence and grade of esophageal varices were made in both groups during the follow-up.		24 months	Yes