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

March 15, 2013
August 26, 2013
January 2003
March 2005   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01931826 on ClinicalTrials.gov Archive Site
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 ]
Same as current
No other outcomes were evaluated. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
 
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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Schistosomiasis Mansoni
  • Portal Hypertension
  • Upper Gastrointestinal Bleeding
  • 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.
  • Active Comparator: Endoscopic treatment alone
    3 to 5 sessions of sclerotherapy till eradication of esophageal varices.
    Intervention: Procedure: Endoscopic treatment
  • Active Comparator: Total EGDS + endoscopy
    Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively.
    Interventions:
    • Procedure: Endoscopic treatment
    • Procedure: Total EGDS+ endoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
March 2009
March 2005   (final data collection date for primary outcome measure)

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.
Both
15 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01931826
UNCISAL-2012-Treatment PHS
No
Celina Maria Costa Lacet, Universidade Estadual de Ciências da Saúde de Alagoas
Universidade Estadual de Ciências da Saúde de Alagoas
Not Provided
Principal Investigator: Celina Lacet, Doctor Universidade Estadual de Ciências da Saúde de Alagoas
Universidade Estadual de Ciências da Saúde de Alagoas
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP