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MCCE in Assessing Efficacy of Gastro-oesophageal Varices

Primary Purpose

Gastroesophageal Varices

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Magnetically controlled capsule endoscopy
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroesophageal Varices

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-75 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

Exclusion Criteria:

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

Sites / Locations

  • Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

magnetically controlled capsule endoscopy

Arm Description

magnetically controlled capsule endoscopy to evaluate the efficacy of the treatment of gastroesophageal varices

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 31, 2021
Last Updated
July 28, 2021
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04984863
Brief Title
MCCE in Assessing Efficacy of Gastro-oesophageal Varices
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Gastro-esophageal varices is one of the complications of portal hypertension in cirrhosis. For patients with moderate to severe varicose veins, international guidelines recommend active treatment, including endoscopic therapy such as endoscopic band ligation (EBL) and interventional radiotherapy such as balloon-occluded retrograde transvenous obliteration (B-RTO)Electronic gastroscopy is the gold standard for the diagnosis of varicose veins at higher blood risk (varicose veins requiring retreatment). However, it is relatively invasive and uncomfortable in the examination process, so that patients with gain-and-compensation cirrhosis are often unwilling to accept it, which is not conducive to the standardized follow-up after the treatment of gastro-esophageal varices.Magnetically controlled capsule endoscopy (MCE) is a non-invasive detection method independently developed in China that covers the whole digestive tract (except colon) mucosa. Patients only need to swallow a capsule endoscope to make repeated observation for many times, and the examination process is painless. It is an ideal method for diagnosing varicose veins with high blood risk (varicose veins that need treatment). Therefore, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Varices

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
magnetically controlled capsule endoscopy
Arm Type
Experimental
Arm Description
magnetically controlled capsule endoscopy to evaluate the efficacy of the treatment of gastroesophageal varices
Intervention Type
Device
Intervention Name(s)
Magnetically controlled capsule endoscopy
Intervention Description
Magnetically controlled capsule endoscopy (MCE) is a non-invasive detection method independently developed in China that covers the whole digestive tract (except colon) mucosa.
Primary Outcome Measure Information:
Title
Evaluating the clinical usefulness of MCE in assessing the efficacy of gastro-oesophageal varices treated under gastroscopy.
Description
Comparing the value of MCE and gastroscopy in the grading of esophagogastric varices
Time Frame
15-30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-75 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Duowu Zou, M.D.
Phone
+86-13901617608
Email
zdw12125@rjh.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duowu Zou
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao Zhang, M.D.
Phone
+86-18019076695
Email
zyrjxh97@sjtu.edu.cn
First Name & Middle Initial & Last Name & Degree
Duowu Zou, M.D.
Phone
+86-13901617608
Email
zdw12125@rjh.com.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29653741
Citation
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. No abstract available. Erratum In: J Hepatol. 2018 Nov;69(5):1207.
Results Reference
result
PubMed Identifier
25177367
Citation
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.
Results Reference
result
PubMed Identifier
26047908
Citation
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. No abstract available.
Results Reference
result
PubMed Identifier
27786365
Citation
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. No abstract available. Erratum In: Hepatology. 2017 Jul;66(1):304.
Results Reference
result
PubMed Identifier
16306522
Citation
Groszmann 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.
Results Reference
result
PubMed Identifier
12586291
Citation
Merli 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.
Results Reference
result

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MCCE in Assessing Efficacy of Gastro-oesophageal Varices

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