Back to resultsEUS-guided Combined Therapy Versus Beta Blocker Therapy in Primary Prophylaxis o GOV II and IGV I
Primary Purpose
Gastric Varix, Cirrhosis, GastroIntestinal Bleeding
Status
Unknown status
Phase
Not Applicable
Locations
Ecuador
Study Type
Interventional
Intervention
Coils + Cyanoacrylate Group + beta-blocker
beta blocker therapy
Sponsored by
About this trial
This is an interventional prevention trial for Gastric Varix
Eligibility Criteria
Inclusion Criteria:
- Above 18 years old
- Writeen informed consent provided.
- Proven GV (GOV II or IGV I) on esophagogastroduodenoscopy and EUS.
- Gastric varices with high-risk of bleeding (large diameter, high MELD score, presence of portal hypertensive gastropathy)
- Patient preference for EUS-guided therapy.
Exclusion Criteria:
- Under 18 years old.
- Refuse to sign written informed consent.
- Pregnancy or nursing.
- Previous treatment of gastric varices.
- Non-cirrhotic portal hypertension
- Concurrent hepato-renal syndrome and/or multi-organ failure.
- Proven malignancy including hepatocellular carcinoma
- Platelet count less than 50,000/ml or International Normalized Rate (INR) >2.
- Severe ascites that increases the distance between gastric or duodenal and gallbladder walls.
- Esophageal stricture.
- Uncontrolled coagulopathy.
Sites / Locations
- Instituto Ecuatoriano de Enfermedades DigestivasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EUS-guided combined therapy
Beta Blocker (Propranolol)
Arm Description
Patients with endoscopic and EUS documented GOV II and IGV I will be included. Procedure will be performed under general anesthesia using a linear array therapeuthic echoendoscope, coils and cyanoacrylate will be injected within the feeder vessel under EUS and fluroscopic guidance.
o Beta-blocker (propranolol) will be started at dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose will be increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was > 90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure < 90 mm Hg or pulse rate < 55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication will be attempted if cessation of the medication did not result in improvement of the reported side-effect.
Outcomes
Primary Outcome Measures
Bleeding rate secondary to gastric varices
Number of patients with melena or hematemesis accompanied by Hemoglobin drop > 2g/dL
Mortality secondary to gastrointestinal bleeding
mortality rate
Secondary Outcome Measures
Number of reinterventions
number of endoscopic or endoscopic ultrasound procedures requiered for the management of gastri varices
Full Information
NCT ID
NCT04075760
First Posted
August 29, 2019
Last Updated
October 8, 2019
Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas
1. Study Identification
Unique Protocol Identification Number
NCT04075760
Brief Title
EUS-guided Combined Therapy Versus Beta Blocker Therapy in Primary Prophylaxis o GOV II and IGV I
Official Title
EUS-guided Combined Therapy of Coiling and 2-octyl-cyanoacrylate Injection With Beta Blocker Therapy Versus Beta Blocker Alone for the Primary Prophylaxis of GOV II and IGV I
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The EUS-guided combined therapy of coilingand 2-octyl-cyanoacrylate in patients with gastric varices reduced rebleeding and need for reintervention in comparison to EUS-guided coiling alone.The purpose of this study is to determine the efficacy of the primary prophylaxis of GOV II and IGV I with the EUS combined therapy versus beta blocker therapy in patients GOV II and IGV that have never bleed.
Detailed Description
Gastric variceal bleeding is a severe condition associated with a high mortality. Bleeding from varices bleeding will be defined as the occurrence of hematemesis and/or melena requiring >2 U of blood or a decrease of 2 gm/dl of hemoglobin if no blood transfusion is given, with the confirmed endocopic visualization of GOV II and IGV I.
The beta blocker therapy is an effective method for the prevention of the first esophageal variceal bleeding; however, the efficacy in preventing first gastric variceal bleeding is controversial.
The investigators aimed to compare the efficacy in preventing the first gastric variceal bleeding in patients with documented GOV II and IGV I.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Varix, Cirrhosis, GastroIntestinal Bleeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial, parallel location , 1:1 allocation
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Endoscopic performing EUS evaluation on follow-up will be masked to initial patient allocation
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EUS-guided combined therapy
Arm Type
Experimental
Arm Description
Patients with endoscopic and EUS documented GOV II and IGV I will be included. Procedure will be performed under general anesthesia using a linear array therapeuthic echoendoscope, coils and cyanoacrylate will be injected within the feeder vessel under EUS and fluroscopic guidance.
Arm Title
Beta Blocker (Propranolol)
Arm Type
Placebo Comparator
Arm Description
o Beta-blocker (propranolol) will be started at dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose will be increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was > 90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure < 90 mm Hg or pulse rate < 55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication will be attempted if cessation of the medication did not result in improvement of the reported side-effect.
Intervention Type
Procedure
Intervention Name(s)
Coils + Cyanoacrylate Group + beta-blocker
Intervention Description
EUS-combined coiling and cyanoacrylate injection into the feeder vessel of GOV II and IGV I
Patients with Gastric Varices GOV II or IGV I that have never bleed and are of high-risk GV according to Baveno VI consensus will be prophylactically obliterated via the EUS-guided coiling and cyanoacrylate injection. Patients will also be on beta-blocker therapy as indicated in the other group.
Intervention Type
Drug
Intervention Name(s)
beta blocker therapy
Intervention Description
A beta-blocker (propranolol) was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was > 90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure < 90 mm Hg or pulse rate < 55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.
Primary Outcome Measure Information:
Title
Bleeding rate secondary to gastric varices
Description
Number of patients with melena or hematemesis accompanied by Hemoglobin drop > 2g/dL
Time Frame
12 months
Title
Mortality secondary to gastrointestinal bleeding
Description
mortality rate
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of reinterventions
Description
number of endoscopic or endoscopic ultrasound procedures requiered for the management of gastri varices
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Above 18 years old
Writeen informed consent provided.
Proven GV (GOV II or IGV I) on esophagogastroduodenoscopy and EUS.
Gastric varices with high-risk of bleeding (large diameter, high MELD score, presence of portal hypertensive gastropathy)
Patient preference for EUS-guided therapy.
Exclusion Criteria:
Under 18 years old.
Refuse to sign written informed consent.
Pregnancy or nursing.
Previous treatment of gastric varices.
Non-cirrhotic portal hypertension
Concurrent hepato-renal syndrome and/or multi-organ failure.
Proven malignancy including hepatocellular carcinoma
Platelet count less than 50,000/ml or International Normalized Rate (INR) >2.
Severe ascites that increases the distance between gastric or duodenal and gallbladder walls.
Esophageal stricture.
Uncontrolled coagulopathy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Robles-Medranda, M.D.
Phone
+593-042109180
Email
carlosoakm@yahoo.es
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Oleas, M.D.
Phone
+593-042109180
Email
robertoleas@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Robles-Medranda, M.D.
Organizational Affiliation
Instituto Ecuatoriano de Enfermedades Digestivas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Ecuatoriano de Enfermedades Digestivas
City
Guayaquil
State/Province
Guayas
ZIP/Postal Code
090505
Country
Ecuador
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Robles-Medranda, M.D.
Phone
593-042109180
Email
carlosoakm@yahoo.es
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21145834
Citation
Mishra SR, Sharma BC, Kumar A, Sarin SK. Primary prophylaxis of gastric variceal bleeding comparing cyanoacrylate injection and beta-blockers: a randomized controlled trial. J Hepatol. 2011 Jun;54(6):1161-7. doi: 10.1016/j.jhep.2010.09.031. Epub 2010 Nov 5.
Results Reference
result
Learn more about this trial
EUS-guided Combined Therapy Versus Beta Blocker Therapy in Primary Prophylaxis o GOV II and IGV I
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