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Primary Prophylaxis of Gastric Variceal Bleed

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ClinicalTrials.gov Identifier: NCT02468180
Recruitment Status : Recruiting
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 bleeding.

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)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Primary Prophylaxis of Gastric Variceal Bleed: Endoscopic Cyanoacrylate Injection Versus Balloon-occluded Retrograde Transvenous Obliteration
Actual Study Start Date : June 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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
Procedure: Endoscopic cyanoacrylate injection
Endoscopic cyanoacrylate injection

Drug: N-butyl-2-cyanoacrylate



Primary Outcome Measures :
  1. Bleeding 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 ]


Information from the National Library of Medicine

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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 with high risk gastric varices (GOV2 or IGV1)
  3. Presence of gastrorenal shunt

Exclusion Criteria:

  1. Acute bleed or past history of bleed from gastric varices
  2. Previous treatment of gastric varices.
  3. Non-cirrhotic portal hypertension
  4. Contraindications to cyanoacrylate injection or BRTO
  5. Portal cavernoma
  6. Hepatorenal syndrome
  7. Proven malignancy including hepatocellular carcinoma
  8. End-stage renal disease under renal replacement therapy;
  9. Cardiorespiratory failure
  10. 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): NCT02468180


Contacts
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Contact: Xufeng Luo, MD luo_xuefeng@yeah.net

Locations
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China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Xuefeng Luo, MD    862885422389      
Sponsors and Collaborators
West China Hospital
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Responsible Party: luo xuefeng, MD, West China Hospital
ClinicalTrials.gov Identifier: NCT02468180    
Other Study ID Numbers: BRTO-NBCA-PP
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