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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Zhengzhou University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • fasting periods of 24 hours

    Other intervention

    Post-balloon occlusion procedure: fasting for 24 hours

  • fasting periods of 48 hours

    Other intervention

    Post-balloon occlusion procedure: fasting for 48 hours

  • fasting periods of 6 hours

    Other intervention

    Post-balloon occlusion procedure: fasting for 6 hours

Treatment groups

339 Participants
are divided into 3 treatment groups
Group A: A Group,Fasting for 6 hours after ligationOther 1 intervention
Group B: B Group,Fasting for 24 hours after ligationOther 1 intervention
Group C: C group ,Fasting for 48 hours after ligationOther 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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