ClinicalTrials.gg
RecruitingNCT07774143Updated Aug 19, 2026

A Prospective, Multicenter, Randomized Controlled Trial Investigating the Impact of Fasting Duration on Postoperative Rebleeding Following Esophageal Variceal Ligation.

An interventional study of fasting periods of 24 hours and fasting periods of 48 hours in Esophageal Varices, sponsored by The First Affiliated Hospital of Zhengzhou University. Recruiting at 12 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by The First Affiliated Hospital of Zhengzhou University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
339
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Esophageal Varices
03

In context

Esophageal and Gastric Varices

150 studies on the registry are indexed under Esophageal and Gastric Varices; 39 are open to participants now.

This study's planned enrollment of 339 is above the median of 110 across 96 interventional studies indexed under Esophageal and Gastric Varices.

Browse Esophageal and Gastric Varices studies →

Lead sponsor

The First Affiliated Hospital of Zhengzhou University is the lead sponsor of 126 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form

Exclusion criteria

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: score>13; profound jaundice (serum >10 mg/dL) accompanied by altered consciousness beyond Stage II or massive ascites; 6.Pregnancy or lactation; 7. Inability to provide .
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
339 participants (estimated)

Study arms

  • Other
    A Group,Fasting for 6 hours after ligation

    Post-banding surgery: fasting for 6 hours. Postoperatively, during the first 6-24 hours: liquid diet; initial dose: 10-50 mL; subsequent doses: 50-250 mL each time, administered every 3 hours; total fluid intake over 24 hours should not exceed 1,000 mL; intravenous fluid replacement should be 1,000-1,500 mL. On postoperative days 2-3: liquid diet with small, frequent meals (if no adverse events occur within the first day postoperatively, such as hematemesis, vomiting, dysphagia, or fever); on postoperative days 4-7: semi-liquid or soft diet; starting from postoperative day 8: gradual transition to a regular diet.

    Other: fasting periods of 6 hours

  • Other
    B Group,Fasting for 24 hours after ligation

    After ligation surgery, fasting for 24 hours is required, with only intravenous fluid support (2,000-2,500 mL/day); Days 2-3 postoperatively: liquid diet; Days 4-7 postoperatively: semi-liquid or soft diet; Starting from day 8 postoperatively: gradual transition to a regular diet.

    Other: fasting periods of 24 hours

  • Other
    C group ,Fasting for 48 hours after ligation

    Post-balloon occlusion procedure: fasting for 48 hours; intravenous fluid support only (2,000-2,500 mL/day); Day 3 post-procedure: liquid diet; Days 4-7 post-procedure: semi-liquid or soft diet; Starting from Day 8 post-procedure: gradual transition to a regular diet.

    Other: fasting periods of 48 hours

Interventions

  • Otherfasting periods of 24 hours

    Post-balloon occlusion procedure: fasting for 24 hours

  • Otherfasting periods of 48 hours

    Post-balloon occlusion procedure: fasting for 48 hours

  • Otherfasting periods of 6 hours

    Post-balloon occlusion procedure: fasting for 6 hours

06

What researchers measure

Primary outcomes

  1. Rate of early postoperative rebleeding

    Time frame: Week 0-6

Secondary outcomes

  1. Length of hospital stay

    Time frame: Week 0-4

  2. nutritional status

    Time frame: Week 0-4

  3. incidence of non-hemorrhagic adverse events

    Time frame: Week 0-4

07

Study locations

12 of 12 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07774143
Responsible party
Hongxia Liang (Chief physician, The First Affiliated Hospital of Zhengzhou University) — Principal investigator
First posted
Aug 19, 2026
Start date
Jun 20, 2026
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Aug 19, 2026

Study contacts

Hongxia Liang
Contact
hxliang@zzu.edu.cn
18595871806

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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