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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07774143

Enrollment

339

Registered

2026-08-19

Start date

2026-06-20

Completion date

2027-06-30

Last updated

2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Varices

Brief 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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Rate of early postoperative rebleeding	Week 0-6

Secondary

Measure	Time frame
Length of hospital stay	Week 0-4
nutritional status	Week 0-4
incidence of non-hemorrhagic adverse events	Week 0-4

Countries

China

Contacts

CONTACTHongxia Liang

hxliang@zzu.edu.cn18595871806

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026