Clinical trial NCT03748563: Accuracy of Magnetically Maneuvered Capsule Endoscopy for Detection of EGV in Patients With Cirrhosis
Official title: Accuracy of Magnetically Maneuvered Capsule Endoscopy for Detection of Esophagogastric Varices in Patients With Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhosis
Portal Hypertension
Esophageal Varices
Gastric Varix
Keywords: Capsule Endoscopy
Liver Cirrhosis
Esophageal Varices
Gastric Varices
Portal hypertensive gastropathy
Portal hypertensive enteropathy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Shanghai East Hospital of Tongji University
name: Yangpu District Central Hospital Affiliated to Tongji University
name: Zhujiang Hospital
name: Qilu Hospital of Shandong University
name: The Third Xiangya Hospital of Central South University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Wuhan Union Hospital, China
name: The Fifth Affiliated Hospital of Zunyi Medical College
name: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: Shanghai Pudong New Area Gongli Hospital
First posted: 2018-11-21
Enrollment: 607
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Diagnostic accuracy study
Primary purpose: DIAGNOSTIC

Brief summary: This is a diagnostic accuracy study. Eligible individuals will be enrolled and asked to undergo ds-MCE and EGD examinations. EGD is the reference standard against which ds-MCE is compared, and it will be performed within 48 hours after ds-MCE examination. The primary outcome is the sensitivity and specificity of ds-MCE in identifying the presence of esophagogastric (EGV) in patients with cirrhosis, using detection by EGD as the reference. The diagnostic accuracy of ds-MCE in detection of high-risk EV, high-risk EGV, EV, large EV, red signs of EV, GV, cardiofundal GV and PHG compared with the EGD will also be assessed. The incidence of PHE in small bowel under ds-MCE, the examination time of ds-MCE and EGD procedures, patient satisfaction assessment and safety evaluation will also be evaluated.

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 esophagogastric varices (EGV), portal hypertensive gastropathy (PHG), and portal hypertensive enteropathy (PHE). Baveno consensus and other practice guidelines recommended that patients with cirrhosis undergo endoscopic screening for EGV 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 EGV 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. Besides, conscious sedation is always required, leading to increased cost, risk, and inconvenience for the patients.These factors lead to a decrease of patient compliance as well as the effectiveness of the screening program.

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 esophagus without the need of sedation. However, the accuracy of ECE is not currently sufficient to replace EGD for the detection and grading for the 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 maneuvered capsule endoscopy (ds-MCE) was developed. The ds-MCE system consists of two parts: the magnetically maneuvered capsule endoscopy (MCE) system and a transparent latex sleeve with a hollow string. 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 can be detached from the string system through injecting air into the hollow string with the syringe after completing the examination of esophagus. The magnetic capsule in the stomach can be accurately controlled through multidimensional rotation and adaptive matching of an external C-arm robot. Previous studies have demonstrated that the diagnostic accuracy of MCE for detecting gastric focal lesions is comparable with that of conventional EGD. Two previously studies 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 enables to provide a more comprehensive evaluation of gastrointestinal changes.

Considering all these backgrounds, in the current prospective study, the primary aim is to assess the diagnostic performance of the ds-MCE in identifying the presence of EGV in cirrhotic patients, using EGD as the reference standard. The diagnostic accuracy of ds-MCE in detection of high-risk EV, high-risk EGV, EV, large EV, red signs of EV, GV, cardiofundal GV and PHG compared with the EGD will also be assessed. The incidence of PHE in small bowel under ds-MCE, the examination time of ds-MCE and EGD procedures, patient satisfaction assessment and safety evaluation will also be evaluated.

Eligibility 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.
5. Able to provide informed consent.

Exclusion Criteria:

1. Patients aged less than 18 years.
2. Patients with Zenker's diverticulum.
3. Patients with active gastrointestinal bleeding.
4. Patients who have participated in or are participating in other clinical trials.
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 plan to undergo magnetic resonance imaging examination before excretion of the MCE.
11. Patients who refuse to give informed consent.
12. Patients with any condition that precludes compliance with the study.

Primary outcomes:
measure: the diagnostic accuracy of the ds-MCE in identifying the presence of esophagogastric varices (EGV)
timeFrame: 2 weeks
Secondary outcomes:
measure: the diagnostic accuracy of the ds-MCE in identifying the presence of esophageal varices (EV)
timeFrame: 2 weeks
measure: the diagnostic accuracy of the ds-MCE in identifying the red sign of EV
timeFrame: 2 weeks
measure: the diagnostic accuracy of the ds-MCE in differentiating large esophageal varices
timeFrame: 2 weeks
measure: the optimal esophageal luminal circumference percentage threshold under ds-MCE for distinguishing large EV
timeFrame: 2 weeks
measure: the diagnostic accuracy of the ds-MCE in differentiating high-risk esophageal varices
timeFrame: 2 weeks
measure: the diagnostic accuracy of the ds-MCE in detection of high-risk EGV
timeFrame: 2 weeks
measure: the diagnostic accuracy of the ds-MCE in detecting gastric varices (GV)
timeFrame: 2 weeks
measure: the diagnostic accuracy of the ds-MCE in detecting cardiofundal gastric varices
timeFrame: 2 weeks
measure: the diagnostic accuracy of the ds-MCE in identifying portal hypertensive gastropathy
timeFrame: 2 weeks
measure: the incidence of portal hypertensive enteropathy (PHE) under ds-MCE
timeFrame: 2 weeks
measure: the examination time of ds-MCE and EGD
timeFrame: 2 weeks
measure: patient satisfaction evaluation of the ds-MCE and EGD
timeFrame: 2 weeks
measure: Safety evaluation
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital,Southern Medical University
state: Guangdong
city: Zhuhai
country: China
facility: the Fifth Affiliated Hospital of Zunyi Medical University
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital, Tongji University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Jiao Tong University affiliated Sixth people's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tongji Hospital, Tongji University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong New Area Gongli Hospital
state: Shanghai
city: Shanghai
country: China
facility: Yangpu District Central Hospital Affiliated to Tongji University
state: Shanghai
city: Xi'an
country: China
facility: First Affiliated Hospital Xi'an Jiaotong University
state: Shanxi
city: Hanzhou
country: China
facility: The First Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Changhai Hospital
name: Zhuan Liao
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: North Italian Endoscopic Club for the Study and Treatment of Esophageal Varices. Prediction of the first variceal hemorrhage in patients with cirrhosis of the liver and esophageal varices. A prospective multicenter study. N Engl J Med. 1988 Oct 13;319(15):983-9. doi: 10.1056/NEJM198810133191505.
citation: Spina GP, Arcidiacono R, Bosch J, Pagliaro L, Burroughs AK, Santambrogio R, Rossi A. Gastric endoscopic features in portal hypertension: final report of a consensus conference, Milan, Italy, September 19, 1992. J Hepatol. 1994 Sep;21(3):461-7. doi: 10.1016/s0168-8278(05)80329-0. No abstract available.
citation: Sarin SK, Lahoti D, Saxena SP, Murthy NS, Makwana UK. Prevalence, classification and natural history of gastric varices: a long-term follow-up study in 568 portal hypertension patients. Hepatology. 1992 Dec;16(6):1343-9. doi: 10.1002/hep.1840160607.
citation: Kodama M, Uto H, Numata M, Hori T, Murayama T, Sasaki F, Tsubouchi N, Ido A, Shimoda K, Tsubouchi H. Endoscopic characterization of the small bowel in patients with portal hypertension evaluated by double balloon endoscopy. J Gastroenterol. 2008;43(8):589-96. doi: 10.1007/s00535-008-2198-1. Epub 2008 Aug 17.
citation: D'Amico G, De Franchis R; Cooperative Study Group. Upper digestive bleeding in cirrhosis. Post-therapeutic outcome and prognostic indicators. Hepatology. 2003 Sep;38(3):599-612. doi: 10.1053/jhep.2003.50385.
citation: Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W; Practice Guidelines Committee of the American Association for the Study of Liver Diseases; Practice Parameters Committee of the American College of Gastroenterology. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007 Sep;46(3):922-38. doi: 10.1002/hep.21907. No abstract available.
citation: Lapalus MG, Dumortier J, Fumex F, Roman S, Lot M, Prost B, Mion F, Ponchon T. Esophageal capsule endoscopy versus esophagogastroduodenoscopy for evaluating portal hypertension: a prospective comparative study of performance and tolerance. Endoscopy. 2006 Jan;38(1):36-41. doi: 10.1055/s-2006-924975.
citation: Gralnek IM, Adler SN, Yassin K, Koslowsky B, Metzger Y, Eliakim R. Detecting esophageal disease with second-generation capsule endoscopy: initial evaluation of the PillCam ESO 2. Endoscopy. 2008 Apr;40(4):275-9. doi: 10.1055/s-2007-995645.
citation: de Franchis R, Eisen GM, Laine L, Fernandez-Urien I, Herrerias JM, Brown RD, Fisher L, Vargas HE, Vargo J, Thompson J, Eliakim R. Esophageal capsule endoscopy for screening and surveillance of esophageal varices in patients with portal hypertension. Hepatology. 2008 May;47(5):1595-603. doi: 10.1002/hep.22227.