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Liver CirrhosisNCT03748563

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

A study testing ds-MCE and EGD in people with Liver Cirrhosis and Portal Hypertension, run by Changhai Hospital at 14 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ds-MCE and EGD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
607 participants
Where
14 sitesChina
Study dates
7 Jan 2021to 6 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • Zhujiang Hospital,Southern Medical University

    Guangzhou, Guangdong, 510000

  • The First Affiliated Hospital of Zhejiang Chinese Medical University

    Hanzhou, Zhejiang, 310000

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250000

  • Ruijin Hospital

    Shanghai, Shanghai Municipality, 200000

  • Shanghai East Hospital, Tongji University School of Medicine

    Shanghai, Shanghai Municipality, 200000

  • Shanghai Jiao Tong University affiliated Sixth people's Hospital

    Shanghai, Shanghai Municipality, 200000

  • Shanghai Tongji Hospital, Tongji University School of Medicine

    Shanghai, Shanghai Municipality, 200000

  • Shanghai Pudong New Area Gongli Hospital

    Shanghai, Shanghai Municipality, 200135

  • Yangpu District Central Hospital Affiliated to Tongji University

    Shanghai, Shanghai Municipality, 200433

  • Changhai Hospital

    Shanghai, 200433

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

    Wuhan, Hubei, 430000

  • First Affiliated Hospital Xi'an Jiaotong University

    Xi’an, Shanxi, 710000

  • the Fifth Affiliated Hospital of Zunyi Medical University

    Zhuhai, Guangdong, 519000

Other trials in China

About this study

Official title: Accuracy of Magnetically Maneuvered Capsule Endoscopy for Detection of Esophagogastric Varices in Patients With Cirrhosis

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.

Read the 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.

Being tested
ds-MCE and EGD
Keywords
Capsule Endoscopy, Liver Cirrhosis, Esophageal Varices, Gastric Varices, Portal hypertensive gastropathy, Portal hypertensive enteropathy
Medical subject headings
Liver Cirrhosis, Hypertension, Portal, Esophageal and Gastric Varices

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ds-MCE and EGDDiagnostic 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.

Study groups in NCT03748563
Study groupRoleWhat they receive
ds-MCE and EGDExperimentalAll the enrolled participants will undergo the examination of detachable string magnetically maneuvered capsule endoscopy (ds-MCE) first, followed by EGD within 48 hours.
Receives: Diagnostic Test: ds-MCE and EGD

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 weeks

Secondary outcomes (13)

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

    The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of EV, using the detection by EGD as the reference.

    Measured: 2 weeks

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

    The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in identifying the red sign of EV, using the detection by EGD as the reference.

    Measured: 2 weeks

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

    The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of large EV, using the detection by EGD as the reference.

    Measured: 2 weeks

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

    To investigate the optimal threshold of the proportion of ds-MCE esophageal luminal circumference occupied by the largest esophageal varix present in differentiating large EV from small or no EV, using the detection by EGD as the reference.

    Measured: 2 weeks

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

    The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of high-risk EV, using the detection by EGD as the reference.

    Measured: 2 weeks

  6. the diagnostic accuracy of the ds-MCE in detection of high-risk EGV

    The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of high-risk EGV, using the detection by EGD as the reference.

    Measured: 2 weeks

  7. the diagnostic accuracy of the ds-MCE in detecting gastric varices (GV)

    The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of GV, using the detection by EGD as the reference.

    Measured: 2 weeks

  8. the diagnostic accuracy of the ds-MCE in detecting cardiofundal gastric varices

    The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of cardiofundal GV, using the detection by EGD as the reference.

    Measured: 2 weeks

  9. the diagnostic accuracy of the ds-MCE in identifying portal hypertensive gastropathy

    The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of portal hypertensive gastropathy (PHG), using the detection by EGD as the reference.

    Measured: 2 weeks

  10. the incidence of portal hypertensive enteropathy (PHE) under ds-MCE

    Endoscopic findings of PHE include mucosal inflammatory-like abnormalities, vascular lesions and spontaneous bleeding.

    Measured: 2 weeks

  11. the examination time of ds-MCE and EGD

    Examination time of ds-MCE include esophageal transit time (ETT), gastric examination time (GET), gastric transit time (GTT), small bowel transit time (SBTT), and total running time (TRT). Examination time of EGD is the time from the endoscope entering to exiting from the esophagus.

    Measured: 2 weeks

  12. patient satisfaction evaluation of the ds-MCE and EGD

    Patient satisfaction score of ds-MCE and EGD procedures.

    Measured: 2 weeks

  13. Safety evaluation

    All adverse events occurring during the study will be recorded.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2018
  2. Study start7 Jan 2021
  3. Primary completion10 Jan 2023
  4. Study completion6 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Diagnostic accuracy study
Masking
None (open label)
Enrolment
607 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03748563
Sponsor's protocol ID
CENTERS
Status last verified
Jul 2023
First submitted
12 Nov 2018
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data can be shared after publication of the main results.

Publications

  • 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.

    PubMed 26047908

  • 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.

    PubMed 3262200

  • 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.

    PubMed 7836719

  • 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.

    PubMed 1446890

  • 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.

    PubMed 18709480

  • 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.

    PubMed 12939586

  • 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.

    PubMed 17879356

  • 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.

    PubMed 16429353

  • 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.

    PubMed 18389444

  • 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.

    PubMed 18435461

  • 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.

    PubMed 38443074

Questions about this trial

What is this clinical trial studying?

A study testing ds-MCE and EGD in people with Liver Cirrhosis and Portal Hypertension, run by Changhai Hospital at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the diagnostic accuracy of the ds-MCE in identifying the presence of esophagogastric varices (EGV) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03748563, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.

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