Acute Upper Gastrointestinal BleedingNCT06031402
Timing of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding
A study testing Endoscopy in people with Acute Upper Gastrointestinal Bleeding and Acute Variceal Bleeding, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
Endoscopy is important for the diagnosis and treatment of acute upper gastrointestinal bleeding (AUGIB), especially acute variceal bleeding (AVB), in patients with liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Upper Gastrointestinal Bleeding, Acute Variceal Bleeding
- What is being tested?
- Endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2024to Dec 2026
- Phase
- Interventional
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
- patients with AUGIB which is highly suspected to be caused by gastroesophageal variceal rupture;
- patients with a diagnosis of liver cirrhosis based on imaging and pathology;
- patients and/or their relatives who sign informed consents;
- patients' age ≥18 years.
Who cannot join
- patients who have undergone endoscopy at other hospitals before admissions;
- patients' hemodynamics are unstable after resuscitation;
- patients with severe cardiovascular or cerebrovascular diseases or renal injury;
- patients who have taken anticoagulants or antiplatelet drugs within 2 weeks before admissions, or are diagnosed with severe hematological diseases;
- patients with human immunodeficiency virus or other acquired or congenital immune deficiency diseases;
- patients with mental illness;
- pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning
About this study
Endoscopy is important for the diagnosis and treatment of acute upper gastrointestinal bleeding (AUGIB), especially acute variceal bleeding (AVB), in patients with liver cirrhosis. However, the optimal timing of endoscopy remains controversial, primarily because the currently available evidence is of poor quality, and the definition of early endoscopy is also very heterogeneous among studies. Herein, a multicenter randomized controlled trial (RCT) is performed to explore the impact of timing of endoscopy on the outcomes of cirrhotic patients with AVB.
Read the detailed description
A total of 368 cirrhotic patients presenting with AUGIB that is highly suspected to be from AVB will be enrolled. They will be stratified according to the severity of liver function and hemodynamic status at admission, and randomly assigned at a 1:1 ratio into early (within 12 hours after admission) and delayed (within 12-24 hours after admission) endoscopy groups within each stratum. The primary outcomes include the rates of 5-day failure to control bleeding after admission and 6-week rebleeding. The secondary outcomes include 6-week mortality and incidence of adverse events.
- Being tested
- Endoscopy
- Keywords
- liver cirrhosis, variceal bleeding, gastrointestinal bleeding, endoscopy, survival, randomized controlled trial
- Medical subject headings
- Liver Cirrhosis, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyProcedure or surgery
Endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Early endoscopy group | Experimental | Intervention of endoscopy is within 12 hours after admission Receives: Procedure: Endoscopy |
| Delayed endoscopy group | Active comparator | Intervention of endoscopy is within 12-24 hours after admission Receives: Procedure: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The failure to control bleeding after admissions
Failure to control bleeding is defined as any one of the three following conditions within 5 days admission: 1) vomiting of fresh blood; 2) suction of more than 100ml of fresh blood from the nasogastric tube; 3) a decrease in hemoglobin concentration of 30g/L in the absence of blood transfusion; or 4) death.
Measured: within 5 days admission
6-week rebleeding
Rebleeding is defined as new onset of hematemesis or melena after successful treatment.
Measured: 6-week
Secondary outcomes (2)
6-week all-cause mortality
Death.
Measured: 6-week
Adverse events
Adverse events include fever, chest pain, dysphagia, and perforation or pneumonia caused by endoscopy or anesthesia.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start4 Sep 2024
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- 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
- Model description
- Before enrollment, all patients and/or their relatives will be informed about the study protocol, and sign the written informed consent forms. Eligible patients are randomly assigned at a ratio of 1:1 to early endoscopy group (within 12 hours after admission) and delayed endoscopy group (within 12-24 hours after admission)
- Masking
- None (open label)
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingshun Qi, General Hospital of Shenyang Military Region
- Investigators
- Xingshun Qi, MD, Principal investigator, General Hospital of Shenyang Military AreaYiling Li, MD, Principal investigator, First Hospital of China Medical UniversityBimin Li, MD, Principal investigator, The First Affiliated Hospital of Nanchang UniversityXuefeng Luo, MD, Principal investigator, West China HospitalXiaofeng Liu, MD, Principal investigator, The 960th Hospital of the Chinese People's Liberation ArmyChunqing Zhang, MD, Principal investigator, Affiliated Provincial Hospital of Shandong First Medical UniversityMingkai Chen, MD, Principal investigator, People's Hospital of Wuhan UniversityDerun Kong, MD, Principal investigator, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031402
- Sponsor's protocol ID
- XHNKKY-ENDO-AVB
- Status last verified
- Sep 2026
- First submitted
- 30 Aug 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bai Z, Wang R, Cheng G, Ma D, Ibrahim M, Chawla S, Qi X. Outcomes of early versus delayed endoscopy in cirrhotic patients with acute variceal bleeding: a systematic review with meta-analysis. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e868-e876. doi: 10.1097/MEG.0000000000002282.
PubMed 35048654Peng Y, Qi X, Dai J, Li H, Guo X. Child-Pugh versus MELD score for predicting the in-hospital mortality of acute upper gastrointestinal bleeding in liver cirrhosis. Int J Clin Exp Med. 2015 Jan 15;8(1):751-7. eCollection 2015.
PubMed 25785053Peng Y, Qi X, Guo X. Child-Pugh Versus MELD Score for the Assessment of Prognosis in Liver Cirrhosis: A Systematic Review and Meta-Analysis of Observational Studies. Medicine (Baltimore). 2016 Feb;95(8):e2877. doi: 10.1097/MD.0000000000002877.
PubMed 26937922Li Y, Li H, Zhu Q, Tsochatzis E, Wang R, Guo X, Qi X. Effect of acute upper gastrointestinal bleeding manifestations at admission on the in-hospital outcomes of liver cirrhosis: hematemesis versus melena without hematemesis. Eur J Gastroenterol Hepatol. 2019 Nov;31(11):1334-1341. doi: 10.1097/MEG.0000000000001524.
PubMed 31524777Qi X, Li Y, Li B, Luo X, Liu X, Zhang C, Chen M, Kong D, Wu Y, Romeiro FG, Basaranoglu M, Zhang J, Li Q, Wang R, Shao X, Guan L, Wang N, You Y, He M, Wang X, Huang J, Wu W, Li Q, Zhang M, Wang G, Zhang C, Cheng D, Zhang Q, Mei X, Sun N, Ban Y, Marcondes MB, Yamashiro FDS, Mutlu E, Zheng Z, Peng M, Xu W, Li Z, Chai L, Linghu E. Timing of endoscopy in cirrhotic patients with acute variceal bleeding: protocol of a multicenter randomized controlled trial. Ther Adv Gastroenterol. 2024 Nov 13;17:17562848241295452. doi: 10.1177/17562848241295452. eCollection 2024.
PubMed 39539489