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Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01931826
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : August 29, 2013
Sponsor:
Information provided by (Responsible Party):
Celina Maria Costa Lacet, Universidade Estadual de Ciências da Saúde de Alagoas

Tracking Information
First Submitted Date  ICMJE March 15, 2013
First Posted Date  ICMJE August 29, 2013
Last Update Posted Date August 29, 2013
Study Start Date  ICMJE January 2003
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
Endoscopic evaluation of presence and grade of esophageal varices were made in both groups during the follow-up. [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 26, 2013)
No other outcomes were evaluated. [ Time Frame: 24 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery
Official Title  ICMJE Treatment of Schistosomal Portal Hypertension: Assessment of Efficacy of Endoscopic Therapy Alone or in the Combined With Surgical Procedure
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Schistosomiasis Mansoni
  • Portal Hypertension
  • Upper Gastrointestinal Bleeding
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2013)
54
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01931826
Other Study ID Numbers  ICMJE UNCISAL-2012-Treatment PHS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celina Maria Costa Lacet, Universidade Estadual de Ciências da Saúde de Alagoas
Study Sponsor  ICMJE Universidade Estadual de Ciências da Saúde de Alagoas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Celina Lacet, Doctor Universidade Estadual de Ciências da Saúde de Alagoas
PRS Account Universidade Estadual de Ciências da Saúde de Alagoas
Verification Date August 2013

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