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Stomach DiseasesNCT05069233

Magnetically Controlled Capsule Endoscopy in Visualization of the UGI and Small Intestine

An observational study of Stomach Diseases and Small Intestine Disease, run by Changhai Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this study, we retrospectively analyzed the videos of combined upper digestive tract and small intestine examination under MCE, so as to clarify the feasibility and diagnostic efficacy of MCE in one-time examination of the upper gastrointestinal and small intestinal mucosa. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stomach Diseases, Small Intestine Disease
What is being tested?
UGI+SB
How many people
593 participants
Where
1 siteChina
Study dates
27 Sep 2021to 30 Dec 2021
Phase
Observational
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients who underwent upper gastrointestinal and small intestinal mucosal examination under MCE at Shanghai Changhai Hospital and Chinese PLA General Hospital after January 2020.

Who may be able to join

  • Age ≥ 18 years old.
  • Those who underwent upper gastrointestinal and small intestinal mucosal examination under magnetically controlled capsule endoscopy at Shanghai Changhai Hospital and Chinese PLA General Hospital after January 2020.
  • Able to provide informed consent.

Who cannot join

  • Patients who fail to follow the prescribed procedures for magnetically controlled capsule endoscopy;
  • Patients who only undergo gastric examination under magnetically controlled capsule endoscopy;
  • Patients who only undergo small bowel examination under magnetic control capsule endoscopy;
  • The patient's basic information in the database is incomplete；
  • Patient fail to be followed up.

Trial locations and contacts

1 site in 1 country.

Zhuan Liao, Professor contact

(81)02131161024

zhuanleo@126.com

Xi Jiang, PhD contact

81-13127952352

jiangxi_stella@126.com

China1 site, 1 recruiting

  • Changhai Hospital

    Shanghai, 200433

    Zhuan Liao, professor, 86-021-31161004, liaozhuan@smmu.edu.cn

    Xi Jiang

    Recruiting

Other trials in China

About this study

Official title: Feasibility of the Magnetically Controlled Capsule Endoscopy in One Time Visualization of the Upper Gastrointestinal Tract and Small Intestine

In this study, we retrospectively analyzed the videos of combined upper digestive tract and small intestine examination under MCE, so as to clarify the feasibility and diagnostic efficacy of MCE in one-time examination of the upper gastrointestinal and small intestinal mucosa.

Read the detailed description

Magnetically controlled capsule endoscopy (MCE), with equally favorable diagnostic accuracy as conventional endoscopy, has become a painless noninvasive diagnostic modality in clinical practice. The more than 8 hours battery life of the MCE enables a further examination of the small bowel. In addition, it has been demonstrated that magnetic steering of capsule endoscopy improves the completion rate of small bowel examination by facilitating passage of the capsule through the pylorus, which further supported MCE as a practical modality for examination of both the stomach and small bowel. In this study, we retrospectively analyzed the videos of combined upper digestive tract and small intestine examination under MCE, so as to clarify the feasibility and diagnostic efficacy of MCE in one-time examination of the upper gastrointestinal and small intestinal mucosa.

Being tested
UGI+SB
Keywords
capsule endoscopy
Medical subject headings
Stomach Diseases

What participants receive

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

  • UGI+SBOther

    Patients who underwent combined upper digestive tract and small intestine examination under MCE.

Study groups in NCT05069233
Study groupRoleWhat they receive
UGI+SBPatients who underwent combined upper digestive tract and small intestine examination under MCE.
Receives: Other: UGI+SB

What is being measured

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

  1. Success rate of UGI and small-bowel examination

    The success rate of upper gastrointestinal tract and small-bowel examination under MCE is evaluated by the technical success rate, a composite outcome including the successful viewing of esophagus, stomach and duodenum, and complete small-bowel examination.

    Measured: 2 weeks

Secondary outcomes (6)

  1. Visualization of the esophagus

    Visualization of the esophagus indicated by the number of images captured for Z-line and how many quadrants of the Z-line were observed. Circumferential visualization of the Z-line is defined by quadrants as follows: less than 2 quadrants (< 50%) observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (>75%) observed; and entire structure (100%) observed.

    Measured: 2 weeks

  2. Visualization score of the gastric mucosa

    Visualization score of the gastric mucosa To objectively evaluate the complete visualization of the gastric mucosa in the 6 anatomic landmarks (cardia, fundus, body, angulus, antrum, and pylorus), a 3-point grading scale was used: 1, poor (<70% of the mucosa was observed), 2, fair (70%-90% of the mucosa was observed), and 3, good (>90% of the mucosa was observed).

    Measured: 2 weeks

  3. Visualization of the small bowel

    Visualization of the small bowel was determined by the percentage of time during which the small-bowel view was clear, defined as not obscured more than 50% of the screen view. The clear-viewing percentage of the total small-bowel transit time assessed by a 4-point scale :0, less than 25%; 1, 25% to 49%; 2, 50% to 75%; and 3, greater than 75%.

    Measured: 2 weeks

  4. Examination time of esophagus, stomach, duodenum and small bowel

    Examination-related parameters included esophageal transit time (ETT), gastric examination time (GET), gastric transit time (GTT), pylorus transit time (PTT), small bowel transit time (SBTT). ETT is defined as the time between the first esophageal image and the first gastric image. GTT is defined as the time between the first gastric image and the first duodenal image. GET is defined as the time for examination of gastric primary anatomic landmarks twice. PTT is defined as the time between the first pyloric image and the first duodenal image. SBTT is defined as the time between the first duodenal image and the first cecal image.

    Measured: 1 month

  5. Detection rate of lesions

    The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, small intestine) found by MCE.

    Measured: 1 month

  6. Adverse events during MCE procedure

    The presence of any adverse events during MCE procedure will be recorded.

    Measured: 1 month

Timeline

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

  1. First posted6 Oct 2021
  2. Study start27 Sep 2021
  3. Primary completion28 Dec 2021 (estimated)
  4. Study completion30 Dec 2021 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
593 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05069233
Sponsor's protocol ID
MCE for UGI+SB
Status last verified
Sep 2021
First submitted
17 Sep 2021
Last updated
6 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.

    PubMed 27211503

  • Jiang X, Qian YY, Liu X, Pan J, Zou WB, Zhou W, Luo YY, Chen YZ, Li ZS, Liao Z. Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video). Gastrointest Endosc. 2018 Oct;88(4):746-754. doi: 10.1016/j.gie.2018.06.031. Epub 2018 Jul 11.

    PubMed 30005825

  • Luo YY, Pan J, Chen YZ, Jiang X, Zou WB, Qian YY, Zhou W, Liu X, Li ZS, Liao Z. Magnetic Steering of Capsule Endoscopy Improves Small Bowel Capsule Endoscopy Completion Rate. Dig Dis Sci. 2019 Jul;64(7):1908-1915. doi: 10.1007/s10620-019-5479-z. Epub 2019 Feb 6.

    PubMed 30725289

  • Chen X, Gao F, Zhang J. Screening for Gastric and Small Intestinal Mucosal Injury with Magnetically Controlled Capsule Endoscopy in Asymptomatic Patients Taking Enteric-Coated Aspirin. Gastroenterol Res Pract. 2018 Nov 15;2018:2524698. doi: 10.1155/2018/2524698. eCollection 2018.

    PubMed 30581462

  • Liu YW, Wang YC, Zhu JH, Jiang X, Zhou W, Zhang J, Liao Z, Linghu EQ. Magnetically controlled capsule endoscopy in one-time gastro-small intestinal joint examination: a two-centre experience. BMC Gastroenterol. 2022 May 4;22(1):222. doi: 10.1186/s12876-022-02302-0.

    PubMed 35509022

Questions about this trial

What is this clinical trial studying?

An observational study of Stomach Diseases and Small Intestine Disease, run by Changhai Hospital at 1 site 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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

Contact Zhuan Liao, Professor ((81)02131161024, zhuanleo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of UGI and small-bowel examination (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 NCT05069233, which also lists 5 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 6 Oct 2021.

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