Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery

• ClinicalTrials.gov Identifier: NCT01931826
• Recruitment Status: Completed
• First Posted: August 29, 2013
• Last Update Posted: August 29, 2013
• Sponsor: Universidade Estadual de Ciências da Saúde de Alagoas
• Information provided by (Responsible Party): Celina Maria Costa Lacet, Universidade Estadual de Ciências da Saúde de Alagoas

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Schistosomiasis Mansoni; Portal Hypertension; Upper Gastrointestinal Bleeding	Procedure: Endoscopic treatment; Procedure: Total EGDS+ endoscopy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Treatment of Schistosomal Portal Hypertension: Assessment of Efficacy of Endoscopic Therapy Alone or in the Combined With Surgical Procedure
• Study Start Date: January 2003
• Actual Primary Completion Date: March 2005
• Actual Study Completion Date: March 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Other Outcome Measures:

1. No other outcomes were evaluated. [ Time Frame: 24 months ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Brazil

Universidade Federal de Alagoas

Maceio, Alagoas, Brazil, 57000000

Sponsors and Collaborators

Universidade Estadual de Ciências da Saúde de Alagoas

Investigators

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

More Information

• Responsible Party: Celina Maria Costa Lacet, Doctor, Universidade Estadual de Ciências da Saúde de Alagoas
• ClinicalTrials.gov Identifier: NCT01931826
• Other Study ID Numbers: UNCISAL-2012-Treatment PHS
• First Posted: August 29, 2013
• Last Update Posted: August 29, 2013
• Last Verified: August 2013

Keywords provided by Celina Maria Costa Lacet, Universidade Estadual de Ciências da Saúde de Alagoas:

Schistosomiasis; Surgical treatment; Endoscopic treatment

Additional relevant MeSH terms:

Schistosomiasis; Schistosomiasis mansoni; Hypertension, Portal; Gastrointestinal Hemorrhage; Hypertension; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Liver Diseases; Digestive System Diseases; Gastrointestinal Diseases; Trematode Infections; Helminthiasis; Parasitic Diseases