Recruiting
A Prospective, Multicenter, Randomized Controlled Trial Investigating the Impact of Fasting Duration on Postoperative Rebleeding Following Esophageal Variceal Ligation.
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.
ClinicalTrials.gov IDNCT07774143
PhaseNA
Enrollment339
SponsorThe First Affiliated Hospital of Zhengzhou University
Age18 Years and older
SexALL
Conditions studied
Esophageal Varices
About this study
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.
Interventions
- Other: fasting periods of 24 hours — Post-balloon occlusion procedure: fasting for 24 hours
- Other: fasting periods of 48 hours — Post-balloon occlusion procedure: fasting for 48 hours
- Other: fasting periods of 6 hours — Post-balloon occlusion procedure: fasting for 6 hours
Primary outcomes
- Rate of early postoperative rebleeding (Week 0-6)
Eligibility information
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.
Study locations
- 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
Showing 10 of 12 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-05.