Liver Cirrhosis Clinical Trial
Official title:
Comparison of Efficacy and Safety of Gastric Variceal Ligation Versus Gastric Variceal Obturation for Secondary Prophylaxis of Gastric Varices
Verified date | November 2018 |
Source | Shanghai Zhongshan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators establish a randomized controlled clinical trial, comparing the efficacy
and prognosis of GVL and GVO in secondary prevention of GVs, especially in patients with
portosystemic shunting, and exploring the endoscopic treatment selection of different types
of GVs.
Outcome expectations: Compared with glue injection, endoscopic ligation for secondary
prevention of gastric varices is safe and effective, especially in patients with
portosystemic shunting.
Status | Not yet recruiting |
Enrollment | 166 |
Est. completion date | June 2020 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients over 18 years of age;Past history of gastroesophageal variceal hemorrhage confirmed by an endoscopic examination Exclusion Criteria: - Patients who are not suitable for endoscopic treatment judged by the clinician; Patients who are not suitable for the ligation treatment because of scar change by repeated glue injection; Patients with acute hemorrhage |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of rebleeding | New onset of hematemesis, coffee-ground vomitus, hematochezia,or melena,with an increasing pulse rate over 100 beats/min and decreasing blood pressure below 90 mmHg after a 24-hour period of stable vital signs and hemoglobin after endoscopic treatment. | 6 months | |
Secondary | Rate of GV eradication | non-visualization of patent GV | 6 months | |
Secondary | Incidence of complications | Huge ulcer on GV, spontaneous bacterial peritonitis, bacteremia | 6 months | |
Secondary | mortality | Survival situation of patience | 6 months |
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