MCCE in Assessing Efficacy of Gastro-oesophageal Varices
Clinical Usefulness of Magnetically Controlled Capsule Endoscopy in Assessing Efficacy of Gastro-oesophageal Varices in Patients With Liver Cirrhosis Treated Under Gastroscopy: a Prospective, Multicenter Trial
1 other identifier
interventional
96
1 country
1
Brief Summary
This study proposed for the first time the use of MCE to evaluate the efficacy of the treatment of gastroesophageal varices, and compared the examination results with the gold standard to explore whether MCE could replace the electronic gastroscopy as the preferred non-invasive evaluation method for the treatment of gastroesophageal varices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 31, 2021
CompletedFirst Posted
Study publicly available on registry
August 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedAugust 2, 2021
January 1, 2021
2.1 years
January 31, 2021
July 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluating the clinical usefulness of MCE in assessing the efficacy of gastro-oesophageal varices treated under gastroscopy.
Comparing the value of MCE and gastroscopy in the grading of esophagogastric varices
15-30 minutes
Study Arms (1)
magnetically controlled capsule endoscopy
EXPERIMENTALmagnetically controlled capsule endoscopy to evaluate the efficacy of the treatment of gastroesophageal varices
Interventions
Magnetically controlled capsule endoscopy (MCE) is a non-invasive detection method independently developed in China that covers the whole digestive tract (except colon) mucosa.
Eligibility Criteria
You may qualify if:
- years old
- Confirmed cirrhosis by clinical or pathological biopsy
- Previous endoscopic treatment of esophageal and gastric varices, including but not limited to sclerotherapy, injection of tissue adhesives, skin entrapment, etc
- Electronic gastroscopy is to be performed
- Voluntary informed consent
You may not qualify if:
- Absolute contraindications:
- Patients without surgical conditions or refusing any abdominal surgery (once the capsule is stranded, it cannot be removed by surgery)
- There is a pacemaker in the body, except that the pacemaker is a new MRI compatible product
- Electronic devices such as cochlear implants, magnetic metal drug infusion pumps, nerve stimulators and magnetic metal foreign bodies are implanted in the body;
- Women during pregnancy
- Relative contraindication:
- Gastrointestinal obstruction, stenosis, and fistula are known or suspected
- Dysphagia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (1)
Ruijin Hospital
Shanghai, Shanghai Municipality, 200433, China
Related Publications (6)
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: 29653741RESULTCremers 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.
PMID: 25177367RESULTde 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: 26047908RESULTGarcia-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: 27786365RESULTGroszmann RJ, Garcia-Tsao G, Bosch J, Grace ND, Burroughs AK, Planas R, Escorsell A, Garcia-Pagan JC, Patch D, Matloff DS, Gao H, Makuch R; Portal Hypertension Collaborative Group. Beta-blockers to prevent gastroesophageal varices in patients with cirrhosis. N Engl J Med. 2005 Nov 24;353(21):2254-61. doi: 10.1056/NEJMoa044456.
PMID: 16306522RESULTMerli M, Nicolini G, Angeloni S, Rinaldi V, De Santis A, Merkel C, Attili AF, Riggio O. Incidence and natural history of small esophageal varices in cirrhotic patients. J Hepatol. 2003 Mar;38(3):266-72. doi: 10.1016/s0168-8278(02)00420-8.
PMID: 12586291RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Duowu Zou
Ruijin Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2021
First Posted
August 2, 2021
Study Start
January 1, 2020
Primary Completion
January 30, 2022
Study Completion
June 30, 2022
Last Updated
August 2, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share