The Timing of Emergency Endoscopy for Esophagogastric Variceal Bleeding in Cirrhosis
NCT ID: NCT04932200
Last Updated: 2021-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
608 participants
OBSERVATIONAL
2021-06-15
2022-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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urgent-endoscopy group
the time interval from gastroenterologic consultation to the start of emergency endoscopy \< 6 hours
No interventions assigned to this group
early-endoscopy group
the time interval from gastroenterologic consultation to the start of emergency endoscopy between 6 and 24 hours
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* The subject (or legal representative/guardian) refused to sign the informed consent
18 Years
ALL
No
Sponsors
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Beijing Friendship Hospital
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
Fudan University
OTHER
Southwest Hospital, China
OTHER
Beijing Shijitan Hospital, Capital Medical University
OTHER
Fuyang NO.2 Renmin Hospital
UNKNOWN
Hubei Hospital of Traditional Chinese Medicine
OTHER
Wuhan No.1 Hospital
OTHER
Wuhan Puren Hospital
OTHER
Tianyou Hospital Affiliated to Wuhan University of Science and Technology
OTHER
The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
OTHER
Yichang Central People's Hospital
OTHER
Shiyan Renmin Hospital
UNKNOWN
Hanyang University
OTHER
The Third People's Hospital of Hubei Province
OTHER
Chibi Renmin Hospital
UNKNOWN
Renmin Hospital of Wuhan University
OTHER
Responsible Party
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ChenMingkai
Professor
Principal Investigators
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Mingkai Chen, PHD
Role: PRINCIPAL_INVESTIGATOR
Renmin Hospital of Wuhan University
Locations
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Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Countries
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Central Contacts
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References
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Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.
Tripathi D, Stanley AJ, Hayes PC, Patch D, Millson C, Mehrzad H, Austin A, Ferguson JW, Olliff SP, Hudson M, Christie JM; Clinical Services and Standards Committee of the British Society of Gastroenterology. U.K. guidelines on the management of variceal haemorrhage in cirrhotic patients. Gut. 2015 Nov;64(11):1680-704. doi: 10.1136/gutjnl-2015-309262. Epub 2015 Apr 17.
Reiberger T, Puspok A, Schoder M, Baumann-Durchschein F, Bucsics T, Datz C, Dolak W, Ferlitsch A, Finkenstedt A, Graziadei I, Hametner S, Karnel F, Krones E, Maieron A, Mandorfer M, Peck-Radosavljevic M, Rainer F, Schwabl P, Stadlbauer V, Stauber R, Tilg H, Trauner M, Zoller H, Schofl R, Fickert P. Austrian consensus guidelines on the management and treatment of portal hypertension (Billroth III). Wien Klin Wochenschr. 2017 Nov;129(Suppl 3):135-158. doi: 10.1007/s00508-017-1262-3. Epub 2017 Oct 23.
de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.
European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018 Aug;69(2):406-460. doi: 10.1016/j.jhep.2018.03.024. Epub 2018 Apr 10. No abstract available.
Cheung J, Soo I, Bastiampillai R, Zhu Q, Ma M. Urgent vs. non-urgent endoscopy in stable acute variceal bleeding. Am J Gastroenterol. 2009 May;104(5):1125-9. doi: 10.1038/ajg.2009.78. Epub 2009 Mar 31.
Hsu YC, Chung CS, Tseng CH, Lin TL, Liou JM, Wu MS, Hu FC, Wang HP. Delayed endoscopy as a risk factor for in-hospital mortality in cirrhotic patients with acute variceal hemorrhage. J Gastroenterol Hepatol. 2009 Jul;24(7):1294-9. doi: 10.1111/j.1440-1746.2009.05903.x.
Chen PH, Chen WC, Hou MC, Liu TT, Chang CJ, Liao WC, Su CW, Wang HM, Lin HC, Lee FY, Lee SD. Delayed endoscopy increases re-bleeding and mortality in patients with hematemesis and active esophageal variceal bleeding: a cohort study. J Hepatol. 2012 Dec;57(6):1207-13. doi: 10.1016/j.jhep.2012.07.038. Epub 2012 Aug 8.
Jung DH, Huh CW, Kim NJ, Kim BW. Optimal endoscopy timing in patients with acute variceal bleeding: A systematic review and meta-analysis. Sci Rep. 2020 Mar 4;10(1):4046. doi: 10.1038/s41598-020-60866-x.
Lau JYW, Yu Y, Tang RSY, Chan HCH, Yip HC, Chan SM, Luk SWY, Wong SH, Lau LHS, Lui RN, Chan TT, Mak JWY, Chan FKL, Sung JJY. Timing of Endoscopy for Acute Upper Gastrointestinal Bleeding. N Engl J Med. 2020 Apr 2;382(14):1299-1308. doi: 10.1056/NEJMoa1912484.
Huh CW, Kim JS, Jung DH, Yang JD, Nam SW, Kwon JH, Kim BW. Optimal endoscopy timing according to the severity of underlying liver disease in patients with acute variceal bleeding. Dig Liver Dis. 2019 Jul;51(7):993-998. doi: 10.1016/j.dld.2019.01.013. Epub 2019 Jan 29.
Other Identifiers
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WDRY2021-K061
Identifier Type: -
Identifier Source: org_study_id
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