A Prospective, Multicenter, Randomized Controlled Trial Investigating the Impact of Fasting Duration on Postoperative Rebleeding Following Esophageal Variceal Ligation.
Recruiting · NCT07774143 · Interventional (participants receive a specific treatment) · Lead sponsor: The First Affiliated Hospital of Zhengzhou University
View the official record on ClinicalTrials.gov →Interventions studied
fasting periods of 24 hoursfasting periods of 48 hoursfasting periods of 6 hours
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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).
- \. 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.
Where it is running
12 locations listed.
- The Fifth People's Hospital of Anyang - Anyang, China
- The Secend People's Hospital of Jiaozuo - Jiaozuo, China
- Huaihe Hospital of Henan University - Kaifeng, China
- Luohe Central Hospital - Luohe, China
- Luoyang Central Hospital - Luoyang, China
- Nanyang Central Hospital - Nanyang, China
- Sanmenxia Central Hospital - Sanmenxia, China
- Shangqiu Municipal Hospital - Shangqiu, China
- The First Affiliated Hospital of Xinxiang Medical University - Xinxiang, China
- Xuchang Central Hospital - Xuchang, China
- the First Affiliated Hospital of Zhengzhou University - Zhengzhou, China
- Zhoukou Central Hospital - Zhoukou, China