About this trial
To evaluate the efficacy and safety of early postoperative oral intake (with a fasting period of 6 hours) versus delayed postoperative oral intake (with fasting periods of 24 hours or 48 hours) in patients with cirrhosis undergoing esophageal variceal ligation therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
1. Uncontrolled active bleeding or concurrent bleeding from gastric fundal varices; 2.History of prior TIPS, EVL, or surgical shunt procedures; 3. Presence of severe systemic diseases, such as sepsis, uremia, or advanced hepatocellular carcinoma (HCC); 4.Mechanical ventilation with retained catheter, inability to take oral intake, or significant dysphagia, or a history of major esophageal/gastric surgery that has impaired swallowing function; 5. Severe hepatic failure: Child-Pugh score>13; profound jaundice (serum bilirubin>10 mg/dL) accompanied by altered consciousness beyond Stage II or massive ascites; 6.Pregnancy or lactation; 7. Inability to provide informed consent.
Trial design
Parallel
Treatments tested in this trial
fasting periods of 24 hours
Other interventionPost-balloon occlusion procedure: fasting for 24 hours
fasting periods of 48 hours
Other interventionPost-balloon occlusion procedure: fasting for 48 hours
fasting periods of 6 hours
Other interventionPost-balloon occlusion procedure: fasting for 6 hours
Treatment groups
Trial outcomes
Primary outcomes
Rate of early postoperative rebleeding
Secondary outcomes
Length of hospital stay
nutritional status
incidence of non-hemorrhagic adverse events
Sponsors and contacts
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