EUS-guided Combined Therapy Versus Beta Blocker Therapy in Primary Prophylaxis o GOV II and IGV I
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
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 29, 2019
CompletedFirst Posted
Study publicly available on registry
September 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedOctober 10, 2019
October 1, 2019
1 year
August 29, 2019
October 8, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Bleeding rate secondary to gastric varices
Number of patients with melena or hematemesis accompanied by Hemoglobin drop \> 2g/dL
12 months
Mortality secondary to gastrointestinal bleeding
mortality rate
12 months
Secondary Outcomes (1)
Number of reinterventions
12 months
Study Arms (2)
EUS-guided combined therapy
EXPERIMENTALPatients 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.
Beta Blocker (Propranolol)
PLACEBO COMPARATORo 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Ecuatoriano de Enfermedades Digestivas
Guayaquil, Guayas, 090505, Ecuador
Related Publications (1)
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.
PMID: 21145834RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Robles-Medranda, M.D.
Instituto Ecuatoriano de Enfermedades Digestivas
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Endoscopic performing EUS evaluation on follow-up will be masked to initial patient allocation
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2019
First Posted
September 3, 2019
Study Start
August 1, 2019
Primary Completion
August 1, 2020
Study Completion
October 1, 2020
Last Updated
October 10, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share