Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
512

Summary

Conditions
  • Cirrhosis, Liver
  • Esophageal Varices
  • Gastric Varix
  • Portal Hypertension
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Diagnostic accuracy studyMasking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 gastroesopha...

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).

Tracking Information

NCT #
NCT03748563
Collaborators
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Ruijin Hospital
  • Shanghai Tongji Hospital, Tongji 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
  • Zhujiang Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • Wuhan Union Hospital, China
  • The First Affiliated Hospital of Zhejiang Chinese Medical University
  • The Fifth Affiliated Hospital of Zunyi Medical College
Investigators
Principal Investigator: Zhuan Liao Changhai Hospital