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Secondary Prophylaxis of Gastric Variceal Bleed

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ClinicalTrials.gov Identifier: NCT02468206
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
luo xuefeng, West China Hospital

Brief Summary:
The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric variceal rebleeding and improvement in survival.

Condition or disease Intervention/treatment Phase
Gastric Varices Procedure: Balloon-occluded retrograde transvenous obliteration Procedure: Endoscopic cyanoacrylate injection Drug: N-butyl-2-cyanoacrylate Drug: Lauromacrogol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endoscopic Cyanoacrylate Injection vs. Balloon-occluded Retrograde Transvenous Obliteration in the Prevention of Gastric Variceal Rebleeding
Actual Study Start Date : June 2015
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : January 7, 2019

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Arm Intervention/treatment
Active Comparator: BRTO
Balloon-occluded retrograde transvenous obliteration
Procedure: Balloon-occluded retrograde transvenous obliteration
Balloon-occluded retrograde transvenous obliteration

Drug: Lauromacrogol
Active Comparator: NBCA
Endoscopic Cyanoacrylate injection in the gastric varix
Procedure: Endoscopic cyanoacrylate injection
Endoscopic cyanoacrylate injection

Drug: N-butyl-2-cyanoacrylate



Primary Outcome Measures :
  1. Rebleeding rate from gastric varices [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Eradication rate of gastric varices [ Time Frame: 3 years ]
  2. Number of participants with increase or decrease in the size of gastric varices [ Time Frame: 3 years ]
  3. Number of participants with appearance or worsening of new oesophageal varices [ Time Frame: 3 years ]
  4. Number of participants with appearance or worsening of portal hypertensive gastropathy [ Time Frame: 3 years ]
  5. Number of participants with appearance or worsening of ascites [ Time Frame: 3 years ]
  6. Number of participants with complication [ Time Frame: 3 years ]
  7. Average in-hospital stay [ Time Frame: 3 years ]
  8. Cost of treatment [ Time Frame: 3 years ]
  9. Mortality rate [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Cirrhosis
  2. Patients who had bled from GOV2 or IGV1(≥5 days and ≤ 28days)
  3. Presence of gastrorenal shunt

Exclusion Criteria:

  1. Previous treatment of gastric varices, including endoscopic therapy, NSBB, TIPS, or surgery
  2. Non-cirrhotic portal hypertension
  3. Contraindications to cyanoacrylate injection or BRTO
  4. Portal cavernoma
  5. Hepatorenal syndrome
  6. Proven malignancy including hepatocellular carcinoma
  7. End-stage renal disease under renal replacement therapy;
  8. Cardiorespiratory failure
  9. Pregnancy or patients not giving informed consent for endoscopic procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468206


Locations
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China, Sichuan
West China Hospital
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
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Responsible Party: luo xuefeng, MD, West China Hospital
ClinicalTrials.gov Identifier: NCT02468206    
Other Study ID Numbers: BRTO-NBCA-SP
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Esophageal and Gastric Varices
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Polidocanol
Sclerosing Solutions
Pharmaceutical Solutions