Endoscopic Ruler for the Assessment of Variceal Bleeding Risks (CHESS2005)

Overview

The presence of varices is a serious complication of portal hypertension in liver disease. To prevent variceal haemorrhage, screening and surveillance aims to detect high-risk varices related to varices size and determine the need for primary prophylaxis. Varices size evaluated by endoscopists might not be perfect reference, influenced by experience and machine. Endoscopic ruler is a novel tool to measure the varices size under the endoscopy. The investigators aim to evaluate the bias of varices size between endoscopists and endoscopic ruler as the reference.

Full Title of Study: “Endoscopic Ruler for the Assessment of Variceal Bleeding Risks in Portal Hypertension (CHESS2005): A Prospective Multicenter Trial”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 13, 2021

Interventions

  • Diagnostic Test: Endoscopic ruler
    • Endoscopic ruler for varices in portal hypertension Product uses: measuring the diameter of the veins under the endoscopy for the assessment of the risk of variceal haemorrhage in patients with portal hypertension Black and white measuring rule is highly recognizable under the endoscopy The width of each cell is 1 mm, and the measuring range is 0-10 mm With smooth edge, safe and reliable

Arms, Groups and Cohorts

  • Overall eligible participants
    • Eligible participants whose varix size will be measured by endoscopists and endoscopic ruler will receive standard esophagogastroduodenoscopy

Clinical Trial Outcome Measures

Primary Measures

  • The intraclass correlation coefficient (ICC) of the varix size and the kappa value of the varices bleeding risk between endoscopists and endoscopic ruler
    • Time Frame: 2020/11/13-2022/11/13

Secondary Measures

  • The ICC value of the varix size and the kappa value of the varices bleeding risk among endoscopists
    • Time Frame: 2020/11/13-2022/11/13
  • The bleeding rate of endoscopic ruler
    • Time Frame: 2020/11/13-2022/11/13
  • The timing of endoscopic ruler
    • Time Frame: 2020/11/13-2022/11/13
  • The correlation coefficient between varices size and hepatic venous pressure gradient
    • Time Frame: 2020/11/13-2022/11/13
  • The correlation coefficient between varices size and decompensated events
    • Time Frame: 2020/11/13-2022/11/13

Participating in This Clinical Trial

Inclusion Criteria

  • age between 18 and 75 years – clinically evident or biopsy-confirmed cirrhosis – Varices diagnosed by endoscopy – written informed consent Exclusion Criteria:
  • red sign – Active upper gastrointestinal bleeding
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 75 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Hepatopancreatobiliary Surgery Institute of Gansu Province
    • Collaborator
      • LanZhou University
    • Provider of Information About this Clinical Study
      • Principal Investigator: Xiaolong Qi, Director, Institute of Portal Hypertension – Hepatopancreatobiliary Surgery Institute of Gansu Province
    • Overall Official(s)
      • Xiaolong Qi, M.D., Study Chair, LanZhou University
      • Fengmei Wang, M.D., Principal Investigator, Tianjin Second People’s Hospital
      • Guoxin Zhang, M.D., Principal Investigator, The First Affiliated Hospital with Nanjing Medical University
      • Shengjuan Hu, M.D., Principal Investigator, People’s Hospital of Ningxia Hui Autonomous Region
      • Xianmei Meng, M.D., Principal Investigator, The Second Affiliated Hospital of Baotou Medical College
      • Xiaoyan Wang, M.D., Principal Investigator, The Third Xiangya Hospital of Central South University
      • Zhijie Feng, M.D., Principal Investigator, The Second Hospital of Hebei Medical University
      • Muhan Lv, M.D., Principal Investigator, The Affiliated Hospital Of Southwest Medical University
      • Yiling Li, M.D., Principal Investigator, First Hospital of China Medical University
    • Overall Contact(s)
      • Xiaolong Qi, M.D., +86 18588602600, qixiaolong@vip.163.com

    References

    Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2. Review.

    Cremers I, Ribeiro S. Management of variceal and nonvariceal upper gastrointestinal bleeding in patients with cirrhosis. Therap Adv Gastroenterol. 2014 Sep;7(5):206-16. doi: 10.1177/1756283X14538688. Review.

    Bendtsen F, Skovgaard LT, Sørensen TI, Matzen P. Agreement among multiple observers on endoscopic diagnosis of esophageal varices before bleeding. Hepatology. 1990 Mar;11(3):341-7.

    Cales P, Pascal JP. Gastroesophageal endoscopic features in cirrhosis: comparison of intracenter and intercenter observer variability. Gastroenterology. 1990 Oct;99(4):1189.

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