A Prospective, Multicenter, Randomized Controlled Trial Investigating the Impact of Fasting Duration on Postoperative Rebleeding Following Esophageal Variceal Ligation.
The First Affiliated Hospital of Zhengzhou University
Phase
Not applicable
Started
2026-06-20
Last updated
2026-08-19
Condition(s) studied
Esophageal Varices
Investigational drug(s) / intervention(s)
fasting periods of 24 hoursfasting periods of 48 hoursfasting periods of 6 hours
fasting periods of 24 hours: Post-balloon occlusion procedure: fasting for 24 hours
fasting periods of 48 hours: Post-balloon occlusion procedure: fasting for 48 hours
fasting periods of 6 hours: Post-balloon occlusion procedure: fasting for 6 hours
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Rate of early postoperative rebleeding — Week 0-6
Trial sites (12)
Facility
City
Region
Status
The Fifth People's Hospital of Anyang
Anyang
China
Recruiting
The Secend People's Hospital of Jiaozuo
Jiaozuo
China
Recruiting
Huaihe Hospital of Henan University
Kaifeng
China
Recruiting
Luohe Central Hospital
Luohe
China
Recruiting
Luoyang Central Hospital
Luoyang
China
Recruiting
Nanyang Central Hospital
Nanyang
China
Recruiting
Sanmenxia Central Hospital
Sanmenxia
China
Recruiting
Shangqiu Municipal Hospital
Shangqiu
China
Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang
China
Recruiting
Xuchang Central Hospital
Xuchang
China
Recruiting
the First Affiliated Hospital of Zhengzhou University
Zhengzhou
China
Recruiting
Zhoukou Central Hospital
Zhoukou
China
Recruiting
More The First Affiliated Hospital of Zhengzhou University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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