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出境医 / 临床实验 / The Timing of Emergency Endoscopy for Esophagogastric Variceal Bleeding in Cirrhosis

The Timing of Emergency Endoscopy for Esophagogastric Variceal Bleeding in Cirrhosis

Study Description
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.

Condition or disease
Liver Cirrhosis Portal Hypertension Esophageal Varix Bleeding

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.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 608 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Multicenter Cohort Study on the Timing of Emergency Endoscopy for Esophagogastric Variceal Bleeding in Cirrhosis
Estimated Study Start Date : June 15, 2021
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022
Arms and Interventions
Group/Cohort
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
Outcome Measures
Primary Outcome Measures :
  1. six-week mortality rate [ Time Frame: 6 weeks after treatment ]
    Patients died in six weeks after emergency endoscopy due to rebleeding or other complications associated with cirrhosis.


Secondary Outcome Measures :
  1. Immediate success hemostasis rate [ Time Frame: 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.

  2. five-day rebleeding rate [ Time Frame: 5 days after treatment ]
    Patients rebleeded due to esophageal and gastric varices bleeding in five days after treatment.

  3. detection rate of bleeding site [ Time Frame: during endoscopy ]
    Identify the site of bleeding during endoscopy.

  4. mean operating time [ Time Frame: during endoscopy ]
    The time interval between the beginning and end of endoscopy.

  5. the needs of salvage treatment [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cirrhosis undergoing emergency endoscopy due to EGVB are enrolled this study.
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
Contacts and Locations

Contacts
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Contact: Mingkai Chen, PHD +86 13720330580 kaimingchen@163.com

Locations
Layout table for location information
China, Hubei
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060
Sponsors and Collaborators
Renmin Hospital of Wuhan University
Beijing Friendship Hospital
The First Affiliated Hospital of Nanchang University
Fudan University
The Southwest Hospital of Army Military Medical University
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
Wuhan Hanyang Hospital
The third people's Hospital of Hubei Province
Chibi Renmin Hospital
Investigators
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Principal Investigator: Mingkai Chen, PHD Renmin Hospital of Wuhan University
Tracking Information
First Submitted Date June 11, 2021
First Posted Date June 21, 2021
Last Update Posted Date June 21, 2021
Estimated Study Start Date June 15, 2021
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 12, 2021) 		six-week mortality rate [ Time Frame: 6 weeks after treatment ]
Patients died in six weeks after emergency endoscopy due to rebleeding or other complications associated with cirrhosis.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 12, 2021)
  • Immediate success hemostasis rate [ Time Frame: 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 [ Time Frame: 5 days after treatment ]
    Patients rebleeded due to esophageal and gastric varices bleeding in five days after treatment.
  • detection rate of bleeding site [ Time Frame: during endoscopy ]
    Identify the site of bleeding during endoscopy.
  • mean operating time [ Time Frame: during endoscopy ]
    The time interval between the beginning and end of endoscopy.
  • the needs of salvage treatment [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with cirrhosis undergoing emergency endoscopy due to EGVB are enrolled this study.
Condition
  • Liver Cirrhosis
  • Portal Hypertension
  • Esophageal Varix Bleeding
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *
  • 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. Erratum in: Hepatology. 2017 Jul;66(1):304.
  • 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, Püspök 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, Schöfl 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.
  • European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; 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. Erratum in: J Hepatol. 2018 Nov;69(5):1207.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 12, 2021) 		608
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mingkai Chen, PHD +86 13720330580 kaimingchen@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04932200
Other Study ID Numbers WDRY2021-K061
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party ChenMingkai, Renmin Hospital of Wuhan University
Study Sponsor Renmin Hospital of Wuhan University
Collaborators
  • Beijing Friendship Hospital
  • The First Affiliated Hospital of Nanchang University
  • Fudan University
  • The Southwest Hospital of Army Military Medical University
  • 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
  • Wuhan Hanyang Hospital
  • The third people's Hospital of Hubei Province
  • Chibi Renmin Hospital
Investigators
Principal Investigator: Mingkai Chen, PHD Renmin Hospital of Wuhan University
PRS Account Renmin Hospital of Wuhan University
Verification Date June 2021