MCCE in Assessing Efficacy of Gastro-oesophageal Varices

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastroesophageal Varices

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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magnetically controlled capsule endoscopy

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

Group Type EXPERIMENTAL

Magnetically controlled capsule endoscopy

Intervention Type DEVICE

Magnetically controlled capsule endoscopy (MCE) is a non-invasive detection method independently developed in China that covers the whole digestive tract (except colon) mucosa.

Interventions

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Magnetically controlled capsule endoscopy

Magnetically controlled capsule endoscopy (MCE) is a non-invasive detection method independently developed in China that covers the whole digestive tract (except colon) mucosa.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No