Detachable String Magnetically Controlled Capsule Endoscopy for Detecting High-risk Varices in Compensated Cirrhosis
1 other identifier
observational
105
2 countries
13
Brief Summary
Gastroesophageal varices is a serious complication of compensated advanced chronic liver disease (cACLD). Primary prophylaxis to reduce the risk of variceal haemorrhage is recommended if high-risk varices (HRV) are detected. We performed this study to compare the accuracy, patients' satisfaction and safety of detection of HRV by detachable string magnetically controlled capsule endoscopy (DS-MCCE) with esophagogastroduodenoscopy (EGD) as the standard.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2018
Longer than P75 for all trials
13 active sites
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
November 9, 2018
CompletedFirst Submitted
Initial submission to the registry
November 17, 2018
CompletedFirst Posted
Study publicly available on registry
November 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2022
CompletedNovember 17, 2020
November 1, 2020
1.1 years
November 17, 2018
November 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic accuracy of magnetically controlled capsule endoscopy for the risk of variceal bleeding
Diagnostic accuracy of magnetically controlled capsule endoscopy to determine the high-risk or low-risk of variceal bleeding when compared with esophagogastroduodenoscopy as the reference standard
1 day
Secondary Outcomes (3)
Diagnostic accuracy of magnetically controlled capsule endoscopy for decompensation or death
3 year
Diagnostic accuracy of other non-invasive methods for the risk of variceal bleeding
1 day
Diagnostic accuracy of other non-invasive methods for decompensation or death
3 year
Study Arms (1)
Overall eligible participants
Eligible participants will receive standard esophagogastroduodenoscopy and magnetically controlled capsule endoscopy (Ankon Medical Technologies Co. Ltd.).
Interventions
Esophagogastroduodenoscopy is performed 2 hours after the magnetically controlled capsule endoscopy (Ankon Medical Technologies Co. Ltd.).
Eligibility Criteria
Participants with compensated cirrhosis
You may qualify if:
- age 18-75 years;
- confirmed cirrhosis based on liver biopsy or clinical findings;
- compensated cirrhosis;
- scheduled to undergo esophagogastroduodenoscopy;
- estimated survival time\> 24 months, and model for end-stage liver disease (MELD) score\< 19;
- with written informed consent.
You may not qualify if:
- contradictions for capsule endoscopy;
- contradictions for standard magnetic resonance imaging examination such as the presence of surgical metallic devices;
- pregnancy or unknown pregnancy status.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- Beijing 302 Hospitalcollaborator
- Sir Run Run Shaw Hospitalcollaborator
- Zhujiang Hospitalcollaborator
- Shandong Provincial Hospitalcollaborator
- Shanghai Tongji Hospital, Tongji University School of Medicinecollaborator
- Third Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Guangdong Second Provincial General Hospitalcollaborator
- The Fifth Affiliated Hospital of Zunyi Medical Collegecollaborator
- LanZhou Universitycollaborator
- Sheffield Teaching Hospitals NHS Foundation Trustcollaborator
- Changhai Hospitalcollaborator
- The Second Affiliated Hospital of Baotou Medical Collegecollaborator
Study Sites (13)
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The Fifth Affiliated Hospital of Zunyi Medical University
Zhuhai, Guangdong, China
Shandong Provincial Hospital affiliated to Shandong University
Jinan, Shandong, China
Changhai Hospital
Shanghai, Shanghai Municipality, China
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Baotou Medical College
Baotou, China
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
Sheffield Teaching Hospitals NHS Trust
Sheffield, United Kingdom
Related Publications (12)
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.
PMID: 30215362BACKGROUNDLiu F, Ning Z, Liu Y, Liu D, Tian J, Luo H, An W, Huang Y, Zou J, Liu C, Liu C, Wang L, Liu Z, Qi R, Zuo C, Zhang Q, Wang J, Zhao D, Duan Y, Peng B, Qi X, Zhang Y, Yang Y, Hou J, Dong J, Li Z, Ding H, Zhang Y, Qi X. Development and validation of a radiomics signature for clinically significant portal hypertension in cirrhosis (CHESS1701): a prospective multicenter study. EBioMedicine. 2018 Oct;36:151-158. doi: 10.1016/j.ebiom.2018.09.023. Epub 2018 Sep 27.
PMID: 30268833BACKGROUNDQi X, Li Z, Huang J, Zhu Y, Liu H, Zhou F, Liu C, Xiao C, Dong J, Zhao Y, Xu M, Xing S, Xu W, Yang C. Virtual portal pressure gradient from anatomic CT angiography. Gut. 2015 Jun;64(6):1004-5. doi: 10.1136/gutjnl-2014-308543. Epub 2014 Nov 14. No abstract available.
PMID: 25398771BACKGROUNDWang FS, Fan JG, Zhang Z, Gao B, Wang HY. The global burden of liver disease: the major impact of China. Hepatology. 2014 Dec;60(6):2099-108. doi: 10.1002/hep.27406. Epub 2014 Oct 29.
PMID: 25164003BACKGROUNDZou WB, Hou XH, Xin L, Liu J, Bo LM, Yu GY, Liao Z, Li ZS. Magnetic-controlled capsule endoscopy vs. gastroscopy for gastric diseases: a two-center self-controlled comparative trial. Endoscopy. 2015 Jun;47(6):525-8. doi: 10.1055/s-0034-1391123. Epub 2015 Jan 15.
PMID: 25590177BACKGROUNDLiao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.
PMID: 27211503BACKGROUNDde 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: 26047908BACKGROUNDBerzigotti A, Seijo S, Arena U, Abraldes JG, Vizzutti F, Garcia-Pagan JC, Pinzani M, Bosch J. Elastography, spleen size, and platelet count identify portal hypertension in patients with compensated cirrhosis. Gastroenterology. 2013 Jan;144(1):102-111.e1. doi: 10.1053/j.gastro.2012.10.001. Epub 2012 Oct 8.
PMID: 23058320BACKGROUNDBhardwaj A, Kedarisetty CK, Vashishtha C, Bhadoria AS, Jindal A, Kumar G, Choudhary A, Shasthry SM, Maiwall R, Kumar M, Bhatia V, Sarin SK. Carvedilol delays the progression of small oesophageal varices in patients with cirrhosis: a randomised placebo-controlled trial. Gut. 2017 Oct;66(10):1838-1843. doi: 10.1136/gutjnl-2016-311735. Epub 2016 Jun 13.
PMID: 27298379BACKGROUNDRey JF, Ogata H, Hosoe N, Ohtsuka K, Ogata N, Ikeda K, Aihara H, Pangtay I, Hibi T, Kudo SE, Tajiri H. Blinded nonrandomized comparative study of gastric examination with a magnetically guided capsule endoscope and standard videoendoscope. Gastrointest Endosc. 2012 Feb;75(2):373-81. doi: 10.1016/j.gie.2011.09.030. Epub 2011 Dec 9.
PMID: 22154417BACKGROUNDWang S, Huang Y, Hu W, Mao H, McAlindon ME, Liu Y, Yang L, Zhang C, Xu M, He C, Dang T, Wu B, Ji D, Zhang L, Mao X, Zhang L, Liu C, Xu D, Li Y, Li G, Han J, Lv F, Liang X, Jin S, Zhang S, Tai FWD, Xu Q, Yang C, Wang G, Wang L, Li B, Yang H, Xie P, Deng L, Ren L, Chang Z, Wang X, Wang S, Gao X, Li J, Zhu L, Wang F, Zhang L, Zhang G, Jiang X, Pan J, Meng W, Li X, Hou J, Dray X, Liao Z, Qi X. Detachable string magnetically controlled capsule endoscopy for detecting high-risk varices in compensated advanced chronic liver disease (CHESS1801): A prospective multicenter study. Lancet Reg Health West Pac. 2020 Dec 11;6:100072. doi: 10.1016/j.lanwpc.2020.100072. eCollection 2021 Jan.
PMID: 34327406DERIVEDHuang Y, Huang F, Yang L, Hu W, Liu Y, Lin Z, Meng X, Zeng M, He C, Xu Q, Xie G, Liu C, Liang M, Li X, Kang N, Xu D, Wang J, Zhang L, Mao X, Yang C, Xu M, Qi X, Mao H. Development and validation of a radiomics signature as a non-invasive complementary predictor of gastroesophageal varices and high-risk varices in compensated advanced chronic liver disease: A multicenter study. J Gastroenterol Hepatol. 2021 Jun;36(6):1562-1570. doi: 10.1111/jgh.15306. Epub 2020 Nov 18.
PMID: 33074566DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaolong Qi, M.D.
LanZhou University
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
November 17, 2018
First Posted
November 21, 2018
Study Start
November 9, 2018
Primary Completion
December 3, 2019
Study Completion
November 8, 2022
Last Updated
November 17, 2020
Record last verified: 2020-11