The Timing of Emergency Endoscopy for Esophagogastric Variceal Bleeding in Cirrhosis

NCT04932200 | Unknown

• 1 other identifier: WDRY2021-K061
• Study Type: observational
• Target: 608
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Portal Hypertension; Esophageal Varix Bleeding

Keywords

esophagogastric variceal bleeding; emergency endoscopy; timing

Outcome Measures

Primary Outcomes (1)

• six-week mortality rate

  Patients died in six weeks after emergency endoscopy due to rebleeding or other complications associated with cirrhosis.

  6 weeks after treatment

Secondary Outcomes (5)

• Immediate success hemostasis rate

  within 24 hours after traetment

• five-day rebleeding rate

  5 days after treatment

• detection rate of bleeding site

  during endoscopy

• mean operating time

  during endoscopy

• the needs of salvage treatment

  6 weeks

Study Arms (2)

urgent-endoscopy group

the time interval from gastroenterologic consultation to the start of emergency endoscopy \< 6 hours

early-endoscopy group

the time interval from gastroenterologic consultation to the start of emergency endoscopy between 6 and 24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cirrhosis undergoing emergency endoscopy due to EGVB are enrolled this study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead
• Beijing Friendship Hospital: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Fudan University: collaborator
• Southwest Hospital, China: collaborator
• Beijing Shijitan Hospital, Capital Medical University: collaborator
• Fuyang NO.2 Renmin Hospital: collaborator
• Hubei Hospital of Traditional Chinese Medicine: collaborator
• Wuhan No.1 Hospital: collaborator
• Wuhan Puren Hospital: collaborator
• Tianyou Hospital Affiliated to Wuhan University of Science and Technology: collaborator
• The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture: collaborator
• Yichang Central People's Hospital: collaborator
• Shiyan Renmin Hospital: collaborator
• Hanyang University: collaborator
• The Third People's Hospital of Hubei Province: collaborator
• Chibi Renmin Hospital: collaborator

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Related Publications (11)

• 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.

  PMID: 27786365 BACKGROUND

• 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.

  PMID: 25887380 BACKGROUND

• 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.

  PMID: 29063233 BACKGROUND

• 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.

  PMID: 26047908 BACKGROUND

• 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.

  PMID: 29653741 BACKGROUND

• 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.

  PMID: 19337243 BACKGROUND

• 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.

  PMID: 19682197 BACKGROUND

• 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.

  PMID: 22885718 BACKGROUND

• 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.

  PMID: 32132589 BACKGROUND

• 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.

  PMID: 32242355 BACKGROUND

• 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.

  PMID: 30803858 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mingkai Chen, PHD

  Renmin Hospital of Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingkai Chen, PHD

CONTACT

+86 13720330580; kaimingchen@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 21, 2021
• Study Start: June 15, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

CN (1)