CHESS1801

  • Research type

    Research Study

  • Full title

    Magnetically Controlled Capsule Endoscopy for Assessing Risk of Gastroesophageal Varices Bleeding in Compensated Liver Cirrhosis (CHESS1801): A Prospective Multicenter Study

  • IRAS ID

    262624

  • Contact name

    Mark McAlindon

  • Contact email

    Mark.McAlindon@sth.nhs.uk

  • Sponsor organisation

    Sheffield Teaching Hospitals NHS FT

  • Clinicaltrials.gov Identifier

    NCT03749954

  • Duration of Study in the UK

    2 years, 4 months, 8 days

  • Research summary

    Gastroesophageal varices occurs in approximately half of the patients with liver cirrhosis. Variceal bleeding is the most common lethal complication directly from cirrhotic portal hypertension. The gold standard for diagnosing gastroesophageal varices and evaluating the risk of variceal bleeding is the esophagogastroduodenoscopy. According to the Baveno VI consensus, for those with high-risk varices (varies needing treatment), either non-selective beta blockers or endoscopic band ligation is recommended for the prevention of the first variceal bleeding. However, the invasiveness and uncomfortableness during the esophagogastroduodenoscopy procedure has hindered its use in clinical practice, especially in patients with compensated liver cirrhosis.

    Magnetically controlled capsule endoscopy, as an emerging non-invasive technique, has been well established and shown the comparable accuracy for detection of focal lesions in the stomach compared with conventional esophagogastroduodenoscopy. In the present study, the investigators aim to conduct a prospective, multi-center diagnostic trial with 18 sites in China and 1 in the UK to further evaluate the diagnostic performance of magnetically controlled capsule endoscopy (Ankon Medical Technologies Co. Ltd.) for assessing risk of gastroesophageal varices bleeding in compensated liver cirrhosis.

  • REC name

    South Central - Hampshire B Research Ethics Committee

  • REC reference

    19/SC/0260

  • Date of REC Opinion

    2 Jul 2019

  • REC opinion

    Further Information Favourable Opinion