How long to fast after esophageal variceal ligation in cirrhosis
Official title: A Prospective, Multicenter, Randomized Controlled Trial Investigating the Impact of Fasting Duration on Postoperative Rebleeding Following Esophageal Variceal Ligation.
Run by The First Affiliated Hospital of Zhengzhou University · NCT07774143 · Data updated 2026-11-12
This trial tests whether starting oral intake 6 hours after EVL is safer and as effective as waiting 24 or 48 hours in adults with cirrhosis and esophageal varices.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 339 (estimated) |
| Sponsor | The First Affiliated Hospital of Zhengzhou University Academic / other |
| Locations | 12 sites (Anyang and 11 other locations) |
| Status | Recruiting |
| Started | June 20, 2026 |
| Main results expected | June 1, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT07774143 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with cirrhosis and severe esophageal varices who have achieved intraoperative hemostasis during EVL and consent to participate.
✕Probably not a fit
Patients with ongoing uncontrolled bleeding, major organ failure, or swallowing impairment may not benefit and could be excluded for safety.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter randomized trial compares early postoperative oral intake with a 6-hour fast to delayed intake with 24- or 48-hour fasts in patients undergoing esophageal variceal ligation for portal hypertension. Participants are adults with cirrhosis and severe varices who have achieved hemostasis during EVL. The study aims to determine the impact on post-procedure rebleeding and safety outcomes. Patients are randomized to one of the fasting-duration arms and followed for postoperative events. The lead site is The First Affiliated Hospital of Zhengzhou University, with several collaborating centers in Henan Province.
Why it matters
Potential benefit: If successful, patients may be able to resume eating sooner after EVL without increasing the risk of rebleeding, improving recovery.
How similar studies have gone: Prior studies in endoscopic variceal management have explored timing of postoperative care, but this specific fasting-duration comparison is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
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
Show 6 more locations
-
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
Study contacts
- Study coordinator: Hongxia Liang
- Email: hxliang@zzu.edu.cn
- Phone: 18595871806
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using TIPS to treat complicated portal hypertension in porto‑sinusoidal vascular disease
This research tries TIPS (a shunt placed in the liver) for people with porto‑sinusoidal vascular disease who have bleeding, refractory ascites, or portal vein thrombosis from portal hypertension.
-
2D-shear wave spleen elastography to detect clinically significant portal hypertension and high-risk esophageal varices
This study tests whether a 2D-shear wave spleen ultrasound can rule in or rule out clinically significant portal hypertension and high‑risk esophageal varices in adults with advanced chronic liver disease.
-
Improving treatment strategies for bleeding from esophageal varices in portal hypertension
This study is trying to find better ways to treat bleeding from swollen veins in the esophagus for people with portal hypertension by personalizing treatment based on their specific conditions.
-
Using fecal calprotectin to predict esophageal varices in cirrhotic patients
This study is testing if measuring a substance in stool can help predict if people with liver cirrhosis have esophageal varices and how serious they are.
-
Comparing two techniques for treating esophageal varices
This study is testing two different techniques for treating esophageal varices to see which one works better at preventing them from coming back.
-
Evaluating carvedilol with or without endoscopic variceal ligation for preventing bleeding in cirrhotic patients
This study is testing if adding a procedure called endoscopic variceal ligation to the medication carvedilol can better prevent bleeding in people with cirrhosis who aren't helped by carvedilol alone.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.