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NCT07774143
A Prospective, Multicenter, Randomized Controlled Trial Investigating the Impact of Fasting Duration on Postoperative Rebleeding Following Esophageal Variceal Ligation.
Conditions: Esophageal Varices
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 339
Sponsor: The First Affiliated Hospital of Zhengzhou University
Location: The Fifth People's Hospital of Anyang Anyang
Summary
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
Inclusion Criteria:
-1. The patient must be aged\>18 years; 2. The diagnosis of portal hypertension must be confirmed, with gastroscopy revealing severe esophageal varices and a positive red sign; 3. For patients undergoing endoscopic variceal ligation (EVL) due to esophageal varices (including those with hemorrhage or those eligible for elective ligation), successful intraoperative ligation is achieved (achieving hemostasis or completing the predetermined ligation procedure).
4\. Sign the informed consent form
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07774143). StuddyBuddy aggregates publicly available trial information.