Esophageal VaricesNCT07774143
A Prospective, Multicenter, Randomized Controlled Trial Investigating the Impact of Fasting Duration on Postoperative Rebleeding Following Esophageal Variceal Ligation.
A study testing fasting periods of 24 hours, fasting periods of 48 hours and fasting periods of 6 hours in people with Esophageal Varices, run by The First Affiliated Hospital of Zhengzhou University at 12 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Varices
- What is being tested?
- fasting periods of 24 hours, fasting periods of 48 hours and fasting periods of 6 hours
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 12 sitesChina
- Study dates
- 20 Jun 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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
Who cannot join
- 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 locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
The Fifth People's Hospital of Anyang
Anyang
Yuzhong Wang
- Recruiting
The Secend People's Hospital of Jiaozuo
Jiaozuo
Yuliang Zhao
- Recruiting
Huaihe Hospital of Henan University
Kaifeng
Zhenkun He
- Recruiting
Luohe Central Hospital
Luohe
Yuli Meng
- Recruiting
Luoyang Central Hospital
Luoyang
Guoqiang Zhang
- Recruiting
Nanyang Central Hospital
Nanyang
Xizeng Zhu
- Recruiting
Sanmenxia Central Hospital
Sanmenxia
Xiaoping Dong
- Recruiting
Shangqiu Municipal Hospital
Shangqiu
Shixi Zhang
- Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang
Daokun Yang
- Recruiting
Xuchang Central Hospital
Xuchang
Weihong Li
- Recruiting
the First Affiliated Hospital of Zhengzhou University
Zhengzhou
Hongxia Liang, 18595871806, hxliang@zzu.edu.cn
- Recruiting
Zhoukou Central Hospital
Zhoukou
Jiaqi Zhang
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.
- Conditions
- Esophageal Varices
- Being tested
- fasting periods of 24 hours, fasting periods of 48 hours, fasting periods of 6 hours
- Medical subject headings
- Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fasting periods of 24 hoursOther
Post-balloon occlusion procedure: fasting for 24 hours
fasting periods of 48 hoursOther
Post-balloon occlusion procedure: fasting for 48 hours
fasting periods of 6 hoursOther
Post-balloon occlusion procedure: fasting for 6 hours
| Study group | Role | What they receive |
|---|---|---|
| A Group,Fasting for 6 hours after ligation | Other | 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. Receives: Other: fasting periods of 6 hours |
| B Group,Fasting for 24 hours after ligation | Other | 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. Receives: Other: fasting periods of 24 hours |
| C group ,Fasting for 48 hours after ligation | Other | 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. Receives: Other: fasting periods of 48 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of early postoperative rebleeding
Measured: Week 0-6
Secondary outcomes (3)
Length of hospital stay
Measured: Week 0-4
nutritional status
Measured: Week 0-4
incidence of non-hemorrhagic adverse events
Measured: Week 0-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start20 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal VaricesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 339 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongxia Liang, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774143
- Sponsor's protocol ID
- 2026-KY-1291-001
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Trial Investigating the Impact of Fasting Duration on Postoperative Rebleeding Following Esophageal Variceal Ligation.
- ClinicalTrials.gov ID
- NCT07774143
- Acronym / sponsor ID
- 2026-KY-1291-001
- Conditions
- Esophageal Varices
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 339 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A Group,Fasting for 6 hours after ligation | Other | Other: fasting periods of 6 hoursPost-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. |
| B Group,Fasting for 24 hours after ligation | Other | Other: fasting periods of 24 hoursAfter 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. |
| C group ,Fasting for 48 hours after ligation | Other | Other: fasting periods of 48 hoursPost-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- -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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fasting periods of 24 hoursPost-balloon occlusion procedure: fasting for 24 hours | Other | B Group,Fasting for 24 hours after ligation |
| fasting periods of 48 hoursPost-balloon occlusion procedure: fasting for 48 hours | Other | C group ,Fasting for 48 hours after ligation |
| fasting periods of 6 hoursPost-balloon occlusion procedure: fasting for 6 hours | Other | A Group,Fasting for 6 hours after ligation |
Primary outcome
Rate of early postoperative rebleeding
Time frame: Week 0-6
3 secondary outcomes
Length of hospital stay
Time frame: Week 0-4
nutritional status
Time frame: Week 0-4
incidence of non-hemorrhagic adverse events
Time frame: Week 0-4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fasting periods of 24 hours, fasting periods of 48 hours and fasting periods of 6 hours in people with Esophageal Varices, run by The First Affiliated Hospital of Zhengzhou University at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongxia Liang (18595871806, hxliang@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of early postoperative rebleeding (time frame: Week 0-6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.