NCT03514966

Repetitive Position Change Improves Gastric Cleanliness for MCE

Completed NA Results posted Last updated 9 July 2019

What this trial tests

NA trial testing Position change group in Stomach Diseases in 83 participants. Completed in 14 June 2018.

Timeline

7 May 2018

Primary endpoint
31 May 2018

14 June 2018

Quick facts

Lead sponsor	Changhai Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	83
Start date	7 May 2018
Primary completion	31 May 2018
Estimated completion	14 June 2018
Sites	1 location across China

Drugs / interventions tested

• Position change group

Conditions studied

• Stomach Diseases — all drugs for Stomach Diseases →

Sponsor

Changhai Hospital

Who can join

18 and older, any sex, with Stomach Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Image Cleanliness of Gastric Cavity Primary · 30 minutes

The image cleanliness of gastric cavity of six primary anatomical landmarks of stomach (cardia, fundus, body, angulus, antrum, and pylorus) were recorded for evaluation. A 4-point grading scale was introduced to define the cleanliness as excellent (no adherent mucus and foam: score 4), good (mild mucus and foam but does not obscure vision: score 3), fair (considerable amount of mucus or foam present precluding a completely reliable examination: score 2) and poor (large amount of mucus or foam residue needing water to clear it: score 1)

cardia

Group	Value	95% CI
Conventional Group	3.0	± 0.6
Position Change Group	3.5	± 0.5

fundus

Group	Value	95% CI
Conventional Group	2.2	± 0.7
Position Change Group	3.0	± 0.6

body

Group	Value	95% CI
Conventional Group	2.7	± 0.7
Position Change Group	3.1	± 0.4

angulus

Group	Value	95% CI
Conventional Group	3.1	± 0.7
Position Change Group	3.7	± 0.5

antrum

Group	Value	95% CI
Conventional Group	3.7	± 0.5
Position Change Group	4.0	± 0.0

pylorus

Group	Value	95% CI
Conventional Group	3.9	± 0.3
Position Change Group	4.0	± 0.0

The Type of Positive Findings Detected by Magnetically Controlled Capsule Gastroscopy Secondary · 30 minutes

Positive findings defined as any pathology detected by Magnetically controlled capsule gastroscopy (MCCG), including polyps, ulcer, gastric fundus varices, submucosal tumor, and carditis.

Group	Value	95% CI
Conventional Group	11
Position Change Group	12

Number of Participants With Adverse Events Secondary · 2 weeks

Safety of MCCG, or adverse events, defined as symptoms or signs such as abdominal distention, nausea, or vomiting, were monitored closely during the MCCG procedure. Capsule retention (i.e., a capsule endoscope remaining in the gastrointestinal tract for more than two weeks or a capsule endoscope that requires directed intervention or therapy to aid its expulsion) was monitored and followed up for up to two weeks.

Group	Value	95% CI
Conventional Group	0
Position Change Group	0

Sponsor's own description

By comparing dimethicone administration with/without subsequent repetitive position change before magnetically controlled capsule endoscopy (MCE) examination, the investigators aim to determine the efficacy of repetitive position change in improving gastric cleanliness for MCE examination.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Repetitive Position Change Improves Gastric Cleanliness for Magnetically Controlled Capsule Gastroscopy.
   Wang YC, Pan J, Jiang X, Su XJ, et al · · 2019 · cited 19× · PMID 30560329 · DOI 10.1007/s10620-018-5415-7