Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery
Primary Purpose
Schistosomiasis Mansoni, Portal Hypertension, Upper Gastrointestinal Bleeding
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Endoscopic treatment
Total EGDS+ endoscopy
Sponsored by
About this trial
This is an interventional prevention trial for Schistosomiasis Mansoni focused on measuring Schistosomiasis, Surgical treatment, Endoscopic treatment
Eligibility 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.
Sites / Locations
- Universidade Federal de Alagoas
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Endoscopic treatment alone
Total EGDS + endoscopy
Arm Description
3 to 5 sessions of sclerotherapy till eradication of esophageal varices.
Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Endoscopic evaluation of presence and grade of esophageal varices were made in both groups during the follow-up.
Full Information
NCT ID
NCT01931826
First Posted
March 15, 2013
Last Updated
August 26, 2013
Sponsor
Universidade Estadual de Ciências da Saúde de Alagoas
1. Study Identification
Unique Protocol Identification Number
NCT01931826
Brief Title
Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery
Official Title
Treatment of Schistosomal Portal Hypertension: Assessment of Efficacy of Endoscopic Therapy Alone or in the Combined With Surgical Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual de Ciências da Saúde de Alagoas
4. Oversight
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schistosomiasis Mansoni, Portal Hypertension, Upper Gastrointestinal Bleeding
Keywords
Schistosomiasis, Surgical treatment, Endoscopic treatment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic treatment alone
Arm Type
Active Comparator
Arm Description
3 to 5 sessions of sclerotherapy till eradication of esophageal varices.
Arm Title
Total EGDS + endoscopy
Arm Type
Active Comparator
Arm Description
Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic treatment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Total EGDS+ endoscopy
Intervention Description
Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively.
Primary Outcome Measure Information:
Title
Sucess of treatment evaluated clinically by the absence of UGIB in the two years o follow-up.
Description
Its purpose was to assess the efficacy of endoscopic treatment alone compared with the efficacy of sclerotherapy preceded by EGDS.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Endoscopic evaluation of presence and grade of esophageal varices were made in both groups during the follow-up.
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
No other outcomes were evaluated.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celina Lacet, Doctor
Organizational Affiliation
Universidade Estadual de Ciências da Saúde de Alagoas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Alagoas
City
Maceio
State/Province
Alagoas
ZIP/Postal Code
57000000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery
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