Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celina Maria Costa Lacet, Universidade Estadual de Ciências da Saúde de Alagoas
ClinicalTrials.gov Identifier:
NCT01931826
First received: March 15, 2013
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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 Intervention
Schistosomiasis Mansoni
Portal Hypertension
Upper Gastrointestinal Bleeding
Procedure: Endoscopic treatment
Procedure: Total EGDS+ endoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Universidade Estadual de Ciências da Saúde de Alagoas:

Primary Outcome Measures:
  • Sucess of treatment evaluated clinically by the absence of UGIB in the two years o follow-up. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Its purpose was to assess the efficacy of endoscopic treatment alone compared with the efficacy of sclerotherapy preceded by EGDS.


Secondary Outcome Measures:
  • Endoscopic evaluation of presence and grade of esophageal varices were made in both groups during the follow-up. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • No other outcomes were evaluated. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: January 2003
Study Completion Date: March 2009
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01931826

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

No publications provided

Responsible Party: Celina Maria Costa Lacet, Doctor, Universidade Estadual de Ciências da Saúde de Alagoas
ClinicalTrials.gov Identifier: NCT01931826     History of Changes
Other Study ID Numbers: UNCISAL-2012-Treatment PHS
Study First Received: March 15, 2013
Last Updated: August 26, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Estadual de Ciências da Saúde de Alagoas:
Schistosomiasis
Surgical treatment
Endoscopic treatment

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Hypertension
Hypertension, Portal
Schistosomiasis
Schistosomiasis mansoni
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Trematode Infections
Helminthiasis
Parasitic Diseases

ClinicalTrials.gov processed this record on August 20, 2014