Esophageal Varix Bleeding, Liver Cirrhosis, Portal Hypertension
Conditions
Keywords
esophagogastric variceal bleeding, emergency endoscopy, timing
Brief summary
This study is a prospective, multi-center and observational clinical study. Investigators would like to explore the optimal emergency endoscopy timing in cirrhosis patients with esophagogastric variceal bleeding (EGVB) by evaluating and comparing the efficacy and safety of emergency endoscopy performed at different times ( within 6 hours or between 6 and 24 hours after gastroenterologic consultation ) and its impact on the short-term prognosis.
Detailed description
Between July 2021 and April 2022, patients with cirrhosis undergoing emergency endoscopy due to EGVB are enrolled consecutively according to the following criteria: (1) age≥18 years; (2) A definite diagnosis of cirrhosis (confirmed by medical history, laboratory examination and imaging examination); (3) The cause of bleeding was identified as esophageal and/or gastric vein rupture. Exclusion criteria are as follows: (1) End-stage diseases of major organs (such as heart failure, chronic obstructive pulmonary disease, end-stage renal disease, and malignancies other than hepatocellular carcinoma); (2) The subject (or legal representative/guardian) refused to sign the informed consent. Patients were divided into urgent-endoscopy group (\< 6h) and early-endoscopy group (6h-24h) according to the time interval from gastroenterologic consultation to the start of emergency endoscopy. Investigators will collect patients' data of baseline character, treatment, postoperative and follow-up. All patients will be followed up until death or the end of the study.
Interventions
None listed
Sponsors
Beijing Friendship Hospital
The First Affiliated Hospital of Nanchang University
Fudan University
Southwest Hospital, China
Beijing Shijitan Hospital, Capital Medical University
Fuyang NO.2 Renmin Hospital
Hubei Hospital of Traditional Chinese Medicine
Wuhan No.1 Hospital
Wuhan Puren Hospital
Tianyou Hospital Affiliated to Wuhan University of Science and Technology
The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
Yichang Central People's Hospital
Shiyan Renmin Hospital
Hanyang University
The Third People's Hospital of Hubei Province
Chibi Renmin Hospital
Renmin Hospital of Wuhan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age≥18 years * A definite diagnosis of cirrhosis (confirmed by medical history, laboratory examination and imaging examination) * The cause of bleeding was identified as esophageal and/or gastric vein rupture
Exclusion criteria
* End-stage diseases of major organs (such as heart failure, chronic obstructive pulmonary disease, end-stage renal disease, and malignancies other than hepatocellular carcinoma) * The subject (or legal representative/guardian) refused to sign the informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| six-week mortality rate | 6 weeks after treatment | Patients died in six weeks after emergency endoscopy due to rebleeding or other complications associated with cirrhosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate success hemostasis rate | within 24 hours after traetment | Successful immediate hemostasis refers to successful hemostasis under endoscopy, and no active bleeding manifestations such as hematemesis, hemorrhagic shock and progressive decline of hemoglobin within 24 hours. |
| five-day rebleeding rate | 5 days after treatment | Patients rebleeded due to esophageal and gastric varices bleeding in five days after treatment. |
| detection rate of bleeding site | during endoscopy | Identify the site of bleeding during endoscopy. |
| mean operating time | during endoscopy | The time interval between the beginning and end of endoscopy. |
| the needs of salvage treatment | 6 weeks | Salvage treatment refers to the additional three-chamber and two-capsule compression hemostasis, re-endoscopic therapy, interventional therapy or surgical treatment due to failure of hemostasis by emergency endoscopy or re-bleeding after successful hemostasis. |
Countries
China
Contacts
Primary ContactMingkai Chen, PHD
Outcome results
None listed