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DS-MCE vs EGD for Diagnosing Gastroesophageal Varices

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748563
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 6, 2019
Sponsor:
Collaborators:
Ruijin Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
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
Information provided by (Responsible Party):
Zhuan Liao, Changhai Hospital

Brief Summary:
The aim of this study is to assess the accuracy of the detachable string magnetically controlled capsule endoscopy (DS-MCE) in identifying and grading gastroesophageal varices in patients undergoing screening or surveillance for gastroesophageal varices using EGD as the golden standard.

Condition or disease Intervention/treatment Phase
Cirrhosis, Liver Portal Hypertension Device: DS-MCE and EGD Not Applicable

Detailed Description:

The presence of large gastroesophageal varices relates to an increased risk of bleeding, esophagogastroduodenoscopy (EGD) is recognized as the gold standard for the detection gastroesophageal varices of cirrhotic patients. EGD is however an invasive procedure and there is potential for procedure-related complications.

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 not accurate enough to replace EGD in diagnosing or grading gastroesophageal varices.

A new technique, so-called detachable string magnetically controlled capsule endoscopy (DS-MCE) was developed by ANKON. The movement of capsule can be controlled by the hollow string in the esophagus. If attached from the hollow string, the capsule can be controlled manually by a magnet robot or automatically using a default mode.

In this study, the primary aim is to assess the accuracy of the DS-MCE in identifying and grading the presence of gastroesophageal varices using EGD as the golden standard.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 512 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A prospective self-controlled comparative multi-center study.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Detachable String Magnetically Controlled Capsule Endoscopy vs. EGD for Diagnosing Gastroesophageal Varices in Patients With Liver Cirrhosis
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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.
Device: DS-MCE and EGD

Procedure of DS-MCE:

The DS-MCE system mainly consists of two parts: the NaviCam magnetic capsule guidance system and the detachable string part. In the esophagus, the movement of capsule can be controlled by the hollow string as the latex sleeve tightly wrapped around the end of the capsule. If attached from the hollow string, the capsule can be controlled manually by a magnet robot in the stomach or automatically using a default mode in the small bowel.

Procedure of EGD:

Subjects will undergo standard esophagogastroduodenoscopy(EGD) procedure within 48 hours after DS-MCE procedure. The EGD will be performed using conventional standard forward viewing upper gastrointestinal video endoscopes.





Primary Outcome Measures :
  1. the diagnostic yield of the DS-MCE in identifying the presence of gastroesophageal varices [ Time Frame: 4 weeks ]
    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 participant patients, using esophagogastroduodenoscopy (EGD) as the golden standard.


Secondary Outcome Measures :
  1. the diagnostic yield of the DS-MCE in differentiating high-risk gastroesophageal varices compared to EGD [ Time Frame: 4 weeks ]

    assess the diagnostic yield (sensitivity, specificity, PPV, NPV) of the DS-MCE in differentiating high-risk gastroesophageal varices compared to EGD.

    "High risk varices" are defined as small sized varices (diameter < 5 mm) with red color signs or large-sized varices (diameter ≥ 5 mm).


  2. the diagnostic yield of the DS-MCE in identifying portal hypertensive gastropathy (PHG) [ Time Frame: 2 weeks ]
    assess the diagnostic yield (sensitivity, specificity, PPV, NPV) of the DS-MCE in identifying portal hypertensive gastropathy (PHG) using the EGD as gold standard.

  3. the prevalence of portal hypertensive enteropathy (PHE) in the small bowel [ Time Frame: 2 weeks ]
    assess the prevalence of PHE in the small bowel of participant patients. The DS-MCE digital image stream will be reviewed by endoscopists, portal hypertensive enteropathy will be classified as absent or present.

  4. circumferential visualization of the Z line [ Time Frame: 2 weeks ]

    the circumferential visualization of the Z line will be calculated during the DS-MCE procedure.

    Circumferential visualization of the Z line by the DS-MCE will be defined by quadrants as follows: Z line not observed at all; less than 2 quadrants (< 50 %) of the Z line observed; between 2 quadrants and 3 quadrants (50 % ± 75 %) observed; more than 3 quadrants (> 75 %) observed; and entire Z line (100 %) observed.


  5. quality score of Z-line images [ Time Frame: 2 weeks ]

    the quality score of air-bubble and saliva interference on the Z-line view will be calculated during DS-MCE procedure.

    The effect of bubbles/saliva on the appearance of the Z line area will be scored as follows: 0 = no interference by bubbles/saliva on the Z line area;1 = minor interference of bubbles/saliva on the Z line area; 2 = major interference of bubbles/saliva on the Z line area.


  6. transit time of DS-MCE in the gastrointestinal tract [ Time Frame: 2 weeks ]

    assess the transit time of DS-MCE in the gastrointestinal tract (esophagus, stomach, small bowel).

    Esophageal transit time: time from the capsule entering to leaving the esophagus.

    Gastric transit time: time from the capsule entering to leaving the stomach.

    Small bowel transit time: time from the capsule entering to leaving the small bowel.


  7. degree of comfort [ Time Frame: 2 weeks ]
    evaluate patient's degree of comfort throughout the DS-MCE procedure. Patients will be asked to fill in a questionnaire to give scores about degree of comfort throughout the procedure. Overall discomfort was scored on a scale of 0 to 10 (0, no discomfort; 10, the overall discomfort of EGD). Lower scores represent that the examination of DS-MCE is more comfortable.

  8. the presence of adverse events during DS-MCE procedure and EGD procedure [ Time Frame: 4 weeks ]
    The presence of adverse events during DS-MCE procedure and EGD procedure will be recorded.



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. Previous history of variceal bleeding.
  4. Previous endoscopic treatment of gastroesophageal varices (such as: endoscopic variceal ligation, endoscopic injection sclerotherapy).
  5. Patients with cancer on active treatment with chemotherapy and/or radiation therapy.
  6. Pregnancy or suspected pregnancy.
  7. Suspected or known intestinal stenosis or other known risk factors for capsule retention.
  8. Pacemaker or other implanted electromedical devices which could interfere with magnetic resonance.
  9. Patients with dysphagia.
  10. Life-threatening conditions.
  11. Patients who refuse to undergo or do not tolerate EGD.
  12. 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
Changhai Hospital Recruiting
Shanghai, China, 200433
Contact: Zhuan Liao    86-21-31161004    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 Jiao Tong University Affiliated Sixth People’s Hospital
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
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: DS-MCE-GOV
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Liver Cirrhosis
Hypertension, Portal
Hypertension
Fibrosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases