Clinical trial NCT04932200: The Timing of Emergency Endoscopy for Esophagogastric Variceal Bleeding in Cirrhosis
Official title: A Prospective Multicenter Cohort Study on the Timing of Emergency Endoscopy for Esophagogastric Variceal Bleeding in Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Portal Hypertension
Esophageal Varix Bleeding
Keywords: esophagogastric variceal bleeding
emergency endoscopy
timing
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
Collaborators: name: Beijing Friendship Hospital
name: The First Affiliated Hospital of Nanchang University
name: Fudan University
name: Southwest Hospital, China
name: Beijing Shijitan Hospital, Capital Medical University
name: Fuyang NO.2 Renmin Hospital
name: Hubei Hospital of Traditional Chinese Medicine
name: Wuhan No.1 Hospital
name: Wuhan Puren Hospital
name: Tianyou Hospital Affiliated to Wuhan University of Science and Technology
name: The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
name: Yichang Central People's Hospital
name: Shiyan Renmin Hospital
name: Hanyang University
name: The Third People's Hospital of Hubei Province
name: Chibi Renmin Hospital
First posted: 2021-06-21
Enrollment: 608
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cirrhosis undergoing emergency endoscopy due to EGVB are enrolled this study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: six-week mortality rate
timeFrame: 6 weeks after treatment
Secondary outcomes:
measure: Immediate success hemostasis rate
timeFrame: within 24 hours after traetment
measure: five-day rebleeding rate
timeFrame: 5 days after treatment
measure: detection rate of bleeding site
timeFrame: during endoscopy
measure: mean operating time
timeFrame: during endoscopy
measure: the needs of salvage treatment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Mingkai Chen, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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