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Accuracy of Magnetically Maneuvered Capsule Endoscopy for Detection of GEV in Patients With Cirrhosis

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ClinicalTrials.gov Identifier: NCT03748563
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : April 1, 2021
Sponsor:
Collaborators:
Ruijin Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Dongfang Hospital Affiliated to Tongji University
Yangpu District Central Hospital Affiliated to Tongji University
Qilu Hospital of Shandong University
The First Affiliated Hospital of Soochow University
The Third Xiangya Hospital of Central South University
First Affiliated Hospital Xi'an Jiaotong University
Wuhan Union Hospital, China
The Fifth Affiliated Hospital of Zunyi Medical College
The First Affiliated Hospital of Zhejiang Chinese Medical University
Zhujiang Hospital
Information provided by (Responsible Party):
Zhuan Liao, Changhai Hospital

Brief Summary:
This is a non-interventional diagnostic accuracy study. Using EGD as the golden standard, to assess the accuracy of the ds-MCE in identifying and grading gastroesophageal varices in patients undergoing screening or surveillance for gastroesophageal varices. And the efficacy of the ds-MCE in detecting various pathological changes of cirrhosis in small bowel will be assessed as well.

Condition or disease Intervention/treatment Phase
Cirrhosis, Liver Portal Hypertension Esophageal Varices Gastric Varix Diagnostic Test: ds-MCE and EGD Not Applicable

Detailed Description:

Cirrhosis is the major cause of liver disease-related morbidity and mortality worldwide. Portal hypertension (PH) is the hemodynamic abnormality in patients with cirrhosis, which is associated with various pathological changes throughout the entire gastrointestinal tract, manifesting as gastroesophageal varices, portal hypertensive gastropathy (PHG), and portal hypertensive enteropathy (PHE). Baveno consensus and other practice guidelines recommended that all patients with cirrhosis undergo endoscopic screening for varices at the time of diagnosis and undergo periodic surveillance endoscopy throughout the whole course of cirrhosis.

Esophagogastroduodenoscopy (EGD) is recognized as the gold standard for detection and follow-up of gastroesophageal varices in cirrhotic patients, allowing for direct mucosal visualization and therapeutic intervention. EGD is however an invasive procedure and there is potential for procedure-related complications, such as perforation and bleeding. The capsule endoscopy (CE) system provides a noninvasive and relatively comfortable approach to visualize the GI tract, and the development of esophageal capsule endoscopy (ECE) makes it possible to capture clear images of esophageal disease without the need for sedation. However, ECE was reported to have variable sensitivity and was not accurate enough to replace EGD in diagnosing or grading esophageal varices. Besides, previous studies presented that the sensitivity of ECE for detecting gastric varices (GVs) and PHG varies from 3% to 69%, which denoted ECE was far from a suitable alternative for diagnosing gastric lesions.

To overcome these limitations, a new technique, so-called detachable string magnetically controlled capsule endoscopy (ds-MCE) was developed. The ds-MCE system consists of two parts: the magnetically controlled capsule endoscopy (MCE) system and a transparent latex sleeve with a hollow string. The magnetically controlled capsule endoscopy (MCE) system (Ankon Technologies, Shanghai, China) detects focal lesions in the stomach with comparable accuracy with conventional EGD. One end of the hollow string is a transparent thin latex sleeve that can be wrapped on the surface of the capsule, and the other end of the string is connected to the syringe. The capsule, which is partially enclosed within the sleeve, can be actively moved in the esophagus through the control of string. In this case, investigator can examine the entire esophageal mucosa several times under real time views. The capsule then could be detached from the string system through injecting air into the hollow string with the syringe after completing the examination of esophagus. The pilot study of ds-MCE confirmed it was a feasible, safe and well-tolerated method for completely viewing esophagus and stomach, without the need for sedation. Besides, the 8-10h battery life of the ds-MCE enables complete examination of the small bowel, which provides the possibility for screening pathological changes in the entire gastrointestinal tract.

Considering all these backgrounds, in the current prospective study, the primary aim is to assess the diagnostic yield of the ds-MCE in identifying the presence of gastroesophageal varices in LC patients using EGD as the golden standard. The secondary aim is to assess the accuracy of ds-MCE in grading esophageal varices (EV), identifying high-risk EVs, gastric varices and portal hypertensive gastropathy (PHG) in LC patients using EGD as the gold standard, and to define the mucosal abnormalities of portal hypertensive enteropathy (PHE).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 591 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Diagnostic accuracy study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Accuracy of Magnetically Maneuvered Capsule Endoscopy for Detection of Gastroesophageal Varices (GEV) in Patients With Cirrhosis: A Multicenter Study
Actual Study Start Date : January 7, 2021
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Experimental: ds-MCE and EGD
All the enrolled participants will undergo the examination of detachable string magnetically controlled capsule endoscopy (ds-MCE) first, followed by EGD within 48 hours.
Diagnostic Test: ds-MCE and EGD

Procedure of ds-MCE:

The ds-MCE system mainly consists of two parts: the NaviCam magnetic capsule endoscopy guidance system and the detachable string part. The capsule, which is partially enclosed within the sleeve, can be actively moved in the esophagus through the control of string. Investigator can examine the entire esophagus several times under real time views. The capsule then could be detached from the string system through injecting air into the hollow string with the syringe after completing the examination of esophagus. Then, the examination of stomach under magnetic control and small bowel under the natural action of peristalsis follows.

Procedure of EGD:

The EGD will be performed using conventional upper gastrointestinal video endoscopy, according to the standard procedure at individual centers. EGD will be performed within 48 hours after ds-MCE procedure and usually during the same endoscopic session.





Primary Outcome Measures :
  1. the diagnostic yield of the ds-MCE in identifying the presence of gastroesophageal varices [ Time Frame: 2 weeks ]
    To assess the diagnostic yield (sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV)) of the ds-MCE in identifying the presence of gastroesophageal varices in cirrhosis patients undergoing screening or surveillance for gastroesophageal varices by EGD.


Secondary Outcome Measures :
  1. the accuracy of the ds-MCE in identifying the presence of esophageal varices [ Time Frame: 2 weeks ]
    To assess the accuracy of the ds-MCE in identifying the presence of esophageal varices, using EGD as the gold standard.

  2. the accuracy of the ds-MCE in differentiating medium/large esophageal varices from small or absent varices [ Time Frame: 2 weeks ]
    To assess the accuracy of the ds-MCE in differentiating medium/large esophageal varices from small or absent varices compared to EGD.

  3. association between the grade (size) of esophageal varices seen on ds-MCE and variceal grade by EGD [ Time Frame: 2 weeks ]
    To identify an association between the grade (size) of esophageal varices seen on ds-MCE (using the circumference grading system) and variceal grade by EGD. And then to select an optimal cutoff value which is sufficient to grade esophageal varices under ds-MCE.

  4. the accuracy of the ds-MCE in differentiating high-risk esophageal varices [ Time Frame: 2 weeks ]
    To assess the accuracy of the ds-MCE in differentiating high-risk esophageal varices compared to EGD.

  5. the accuracy of the ds-MCE in detecting gastric varices [ Time Frame: 2 weeks ]
    To assess the accuracy of the ds-MCE in detecting gastric varices compared to EGD.

  6. the diagnostic accuracy of the ds-MCE in identifying portal hypertensive gastropathy [ Time Frame: 2 weeks ]
    To assess the diagnostic accuracy of the ds-MCE in identifying portal hypertensive gastropathy (PHG) compared to EGD.

  7. the prevalence and classification of the mucosal abnormalities of portal hypertensive enteropathy [ Time Frame: 2 weeks ]
    To assess the prevalence and classification of the mucosal abnormalities of portal hypertensive enteropathy (PHE) under ds-MCE.

  8. the association between the mucosal abnormalities of PHE and other clinical characteristics related to liver disease [ Time Frame: 2 weeks ]
    To determine the association between the mucosal abnormalities of portal hypertensive enteropathy (PHE) and the severity of liver disease, gastroesophageal varices, portal gastropathy, or other clinical characteristics.

  9. the transit time of ds-MCE in the GI tract [ Time Frame: 2 weeks ]
    To evaluate the transit time of ds-MCE in the gastrointestinal tract (esophagus, stomach and small bowel).

  10. the patient satisfaction of the ds-MCE [ Time Frame: 2 weeks ]
    To assess the patient satisfaction of the ds-MCE compared to standard EGD.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Gender is not limited.
  2. Patients aged 18 years or older.
  3. Both inpatients and outpatients.
  4. Clinically evident or biopsy-proven liver cirrhosis, without previous diagnosis of gastroesophageal varices but with clinical indication for screening endoscopy for the detection of varices, or with prior endoscopic diagnosis of gastroesophageal varices and indication for surveillance endoscopy.
  5. Able to provide informed consent.

Exclusion Criteria:

  1. Patients aged less than 18 years.
  2. Patients with active upper gastrointestinal bleeding.
  3. Patients who have participated in or are participating in other clinical trials within three months.
  4. Patients with cancer on active treatment with chemotherapy and/or radiation therapy.
  5. Pregnancy or suspected pregnancy.
  6. Suspected or known intestinal stenosis or other known risk factors for capsule retention.
  7. Pacemaker or other implanted electromedical devices which could interfere with magnetic resonance.
  8. Patients with dysphagia.
  9. Life-threatening conditions.
  10. Patients who refuse to undergo or can't tolerate EGD.
  11. Patients whose consents for removal of remained ds-MCE are unable to be obtained.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748563


Contacts
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Contact: Zhuan Liao, M.D. 86-21-31161004 liaozhuan@smmu.edu.cn

Locations
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China, Guangdong
Zhujiang Hospital Not yet recruiting
Guangzhou, Guangdong, China, 510000
Contact: Hua Mao       1109663087@qq.com   
the Fifth Affiliated Hospital of Zunyi Medical University Not yet recruiting
Zhuhai, Guangdong, China, 519000
Contact: Chaohui He       zhaohui0415@163.com   
China, Hubei
Wuhan Union Hospital, China Not yet recruiting
Wuhan, Hubei, China, 430000
Contact: Jun Liu       liujun0129@hust.edu.cn   
China, Hunan
The Third Xiangya Hospital of Central South University Not yet recruiting
Changsha, Hunan, China, 410000
Contact: Xiaoyan Wang       wxy220011@163.com   
China, Jiangxi
The First Affiliated Hospital of Soochow University Not yet recruiting
Suzhou, Jiangxi, China, 215000
Contact: Rui Li       sdfyylirui@126.com   
China, Shandong
Qilu Hospital of Shandong University Not yet recruiting
Jinan, Shandong, China, 250000
Contact: Xiuli Zuo       zuoxiuli_s@163.com   
China, Shanghai
Dongfang Hospital Affiliated to Tongji University Not yet recruiting
Shanghai, Shanghai, China, 200000
Contact: Meidong Xu       xumeidongeh@126.com   
Ruijin Hospital Not yet recruiting
Shanghai, Shanghai, China, 200000
Contact: Duowu Zou       zdw_pi@163.com   
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200000
Contact: Xinjian Wan       slwanxj2019@163.com   
Shanghai Tongji Hospital, Tongji University School of Medicine Not yet recruiting
Shanghai, Shanghai, China, 200000
Contact: Changqing Yang       cqyang@tongji.edu.cn   
Yangpu District Central Hospital Affiliated to Tongji University Not yet recruiting
Shanghai, Shanghai, China, 200433
Contact: Li Li       11i10437@sina.com   
China, Shanxi
First Affiliated Hospital Xi'an Jiaotong University Not yet recruiting
Xi'an, Shanxi, China, 710000
Contact: Shuixiang He       hesx123@126.com   
China, Zhejiang
The First Affiliated Hospital of Zhejiang Chinese Medical University Not yet recruiting
Hanzhou, Zhejiang, China, 310000
Contact: Shuo Zhang       zhangshuotcm@163.com   
China
Changhai Hospital Recruiting
Shanghai, China, 200433
Contact: Zhuan Liao, professor    86-021-31161004    liaozhuan@smmu.edu.cn   
Sub-Investigator: Xi Jiang         
Sub-Investigator: Jun Pan         
Sponsors and Collaborators
Changhai Hospital
Ruijin Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Dongfang Hospital Affiliated to Tongji University
Yangpu District Central Hospital Affiliated to Tongji University
Qilu Hospital of Shandong University
The First Affiliated Hospital of Soochow University
The Third Xiangya Hospital of Central South University
First Affiliated Hospital Xi'an Jiaotong University
Wuhan Union Hospital, China
The Fifth Affiliated Hospital of Zunyi Medical College
The First Affiliated Hospital of Zhejiang Chinese Medical University
Zhujiang Hospital
Investigators
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Principal Investigator: Zhuan Liao Changhai Hospital
Publications:

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Responsible Party: Zhuan Liao, Professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03748563    
Other Study ID Numbers: CENTERS
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After finishing this study, we will make the data available to other researchers: including study protocol, statistical analysis plan (SAP), informed consent form (ICF), clinical study report (CSR)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 3 years.
Access Criteria: The website of the journal where the results published, and ClinicalTrials.gov web site.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhuan Liao, Changhai Hospital:
Capsule Endoscopy
Portal Hypertension
Cirrhosis
Esophageal Varices
Gastric Varix
Portal hypertensive enteropathy
Additional relevant MeSH terms:
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Liver Cirrhosis
Hypertension, Portal
Esophageal and Gastric Varices
Hypertension
Varicose Veins
Fibrosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases