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

NCT03748563 | Completed

• 1 other identifier: CENTERS
• Study Type: interventional
• Target: 607
• Locations: 1 country
• Sites: 14

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.

Conditions

Liver Cirrhosis; Portal Hypertension; Esophageal Varices; Gastric Varix

Keywords

Capsule Endoscopy; Liver Cirrhosis; Esophageal Varices; Gastric Varices; Portal hypertensive gastropathy; Portal hypertensive enteropathy

Outcome Measures

Primary Outcomes (1)

• the diagnostic accuracy of the ds-MCE in identifying the presence of esophagogastric varices (EGV)

  the sensitivity and specificity of ds-MCE in identifying EGV in patients with cirrhosis, using the detection by EGD as the reference.

  2 weeks

Secondary Outcomes (13)

• the diagnostic accuracy of the ds-MCE in identifying the presence of esophageal varices (EV)

  2 weeks

• the diagnostic accuracy of the ds-MCE in identifying the red sign of EV

  2 weeks

• the diagnostic accuracy of the ds-MCE in differentiating large esophageal varices

  2 weeks

• the optimal esophageal luminal circumference percentage threshold under ds-MCE for distinguishing large EV

  2 weeks

• the diagnostic accuracy of the ds-MCE in differentiating high-risk esophageal varices

  2 weeks

Study Arms (1)

ds-MCE and EGD

EXPERIMENTAL

All the enrolled participants will undergo the examination of detachable string magnetically maneuvered capsule endoscopy (ds-MCE) first, followed by EGD within 48 hours.

Diagnostic Test: ds-MCE and EGD

Interventions

ds-MCE and EGD DIAGNOSTIC_TEST

Procedure of ds-MCE: The ds-MCE system mainly consists of two parts: the NaviCam magnetically maneuvered capsule endoscopy 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. After completing the esophageal examination, the capsule could be detached from the string through injecting air into the hollow string with the syringe. Then, the examination of stomach under magnetic control and small bowel under the natural action of gastrointestinal peristalsis follows. Procedure of EGD: The esophagogastroduodenoscopy (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.

ds-MCE and EGD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gender is not limited.
• Patients aged 18 years or older.
• Both inpatients and outpatients.
• Clinically evident or biopsy-proven liver cirrhosis.
• Able to provide informed consent.

You may not qualify if:

• Patients aged less than 18 years.
• Patients with Zenker's diverticulum.
• Patients with active gastrointestinal bleeding.
• Patients who have participated in or are participating in other clinical trials.
• Pregnancy or suspected pregnancy.
• Suspected or known intestinal stenosis or other known risk factors for capsule retention.
• Pacemaker or other implanted electromedical devices which could interfere with magnetic resonance.
• Patients with dysphagia.
• Life-threatening conditions.
• Patients plan to undergo magnetic resonance imaging examination before excretion of the MCE.
• Patients who refuse to give informed consent.
• Patients with any condition that precludes compliance with the study.

Sponsors & Collaborators

• Changhai Hospital: lead
• Ruijin Hospital: collaborator
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator
• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: collaborator
• Shanghai East Hospital of Tongji University: collaborator
• Yangpu District Central Hospital Affiliated to Tongji University: collaborator
• Zhujiang Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• The Fifth Affiliated Hospital of Zunyi Medical College: collaborator
• The First Affiliated Hospital of Zhejiang Chinese Medical University: collaborator
• Shanghai Pudong New Area Gongli Hospital: collaborator

Study Sites (14)

Zhujiang Hospital,Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

the Fifth Affiliated Hospital of Zunyi Medical University

Zhuhai, Guangdong, 519000, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

Location

Ruijin Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

Shanghai Jiao Tong University affiliated Sixth people's Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

Shanghai Pudong New Area Gongli Hospital

Shanghai, Shanghai Municipality, 200135, China

Location

Yangpu District Central Hospital Affiliated to Tongji University

Shanghai, Shanghai Municipality, 200433, China

Location

First Affiliated Hospital Xi'an Jiaotong University

Xi’an, Shanxi, 710000, China

Location

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hanzhou, Zhejiang, 310000, China

Location

Changhai Hospital

Shanghai, 200433, China

Location

Related Publications (11)

• 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.

  PMID: 26047908 BACKGROUND

• 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.

  PMID: 3262200 BACKGROUND

• 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.

  PMID: 7836719 BACKGROUND

• 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.

  PMID: 1446890 BACKGROUND

• 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.

  PMID: 18709480 BACKGROUND

• 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.

  PMID: 12939586 BACKGROUND

• 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.

  PMID: 17879356 BACKGROUND

• 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.

  PMID: 16429353 BACKGROUND

• 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.

  PMID: 18389444 BACKGROUND

• 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.

  PMID: 18435461 BACKGROUND

• Jiang X, Pan J, Xu Q, Song YH, Sun HH, Peng C, Qi XL, Qian YY, Zou WB, Yang Y, Jin SQ, Duan BS, Wu S, Chu Y, Xiao DH, Hu LJ, Cao JZ, Dai JF, Liu X, Xia T, Zhou W, Chen T, Zhou CH, Wu W, Liu SJ, Yang ZY, Wang F, Zhang L, Li CZ, Xu H, Wang JX, Wei B, Lin Y, Deng X, Qu LH, Shen YQ, Wang H, Huang YF, Bao HB, Zhang S, Li L, Shi YH, Wang XY, Zou DW, Wan XJ, Xu MD, Mao H, He CH, Li Z, Zuo XL, He SX, Xie XP, Liu J, Yang CQ, Spada C, Li ZS, Liao Z. Diagnostic accuracy of magnetically guided capsule endoscopy with a detachable string for detecting oesophagogastric varices in adults with cirrhosis: prospective multicentre study. BMJ. 2024 Mar 5;384:e078581. doi: 10.1136/bmj-2023-078581.

  PMID: 38443074 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal; Esophageal and Gastric Varices

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Zhuan Liao

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Diagnostic accuracy study

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 21, 2018
• Study Start: January 7, 2021
• Primary Completion: January 10, 2023
• Study Completion: March 6, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 years.
• Access Criteria: The website of the journal where the results published, and ClinicalTrials.gov web site.

Locations

CN (14)