NCT05069233

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
593

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

September 17, 2021

Last Update Submit

September 28, 2021

Conditions

Keywords

capsule endoscopy

Outcome Measures

Primary Outcomes (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.

    2 weeks

Secondary Outcomes (6)

  • Visualization of the esophagus

    2 weeks

  • Visualization score of the gastric mucosa

    2 weeks

  • Visualization of the small bowel

    2 weeks

  • Examination time of esophagus, stomach, duodenum and small bowel

    1 month

  • Detection rate of lesions

    1 month

  • +1 more secondary outcomes

Study Arms (1)

UGI+SB

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

Other: UGI+SB

Interventions

UGI+SBOTHER

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

UGI+SB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 27211503BACKGROUND
  • 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.

    PMID: 30005825BACKGROUND
  • 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.

    PMID: 30725289BACKGROUND
  • 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.

    PMID: 30581462BACKGROUND
  • 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.

MeSH Terms

Conditions

Stomach Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Zhuan Liao

    Changhai Hospital,Shanghai,China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuan Liao, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 17, 2021

First Posted

October 6, 2021

Study Start

September 27, 2021

Primary Completion

December 28, 2021

Study Completion

December 30, 2021

Last Updated

October 6, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations