NCT04296513

Brief Summary

Gastric cancer is the third most common cause of cancer-related death worldwide (1). Upper endoscopy is necessary to detect neoplastic macroscopic features at an early stage, but subtle abnormalities in the gastric mucosa are often missed or misdiagnosed (1). Helicobacter pylori (Hp) is involved in the pathogenesis of gastric diseases, such as, peptic ulcers, gastric lymphoma, and gastric cancer. Therefore, the necessity to recognize malignant gastric lesions at an early stage is imperative.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2020

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

March 3, 2020

Last Update Submit

February 9, 2021

Conditions

Gastritis, AtrophicHelicobacter Pylori InfectionIntestinal MetaplasiaGastritis

Keywords

endoscopygastritis

Outcome Measures

Primary Outcomes (3)

  • 1. Overall accuracy of High-definition white light endoscopy to detect lesions compatible with gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.

    histological analysis of gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.

    3-month after index endoscopy

  • 2. Overall accuracy of optical enhancement with optical magnification to detect lesions compatible with gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.

    histological analysis of gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.

    3-month after index endoscopy

  • 3. Comparative analysis between High-definition white light endoscopy and optical enhancement with optical magnification with histological analysis.

    statistical analysis of the accuracy for both diagnostic methods

    1-month after finishing enrollment

Study Arms (2)

High-Definition white light endoscopy.

evaluation of the gastric mucosa with high-definition white-light endoscopy (EG-29i10 gastroscope and EPKi7010 video processor). The endoscopy images will be seen on a 27inch, flat panel, high definition LCD monitor (Radiance™ ultraSC-WU27-G1520 model) by one endoscopist, randomly assigned via esophagogastroduodenoscopy.

Diagnostic Test: High-Definition white light endoscopy.

High-definition magnification with digital chromoendoscopy.

The subject will be evaluated by upper endoscopy with the OE System (EPK-i7010 HD Video Processor and MagniView™ EG-2990Zi Video Gastroscope) with intravenous sedation in a standardized manner. This technique involves the use of a distal black rubber hood (OE-A58; Pentax) at the tip of the endoscope, to fix the distance between the tip of the endoscope and the gastric mucosa at 2 mm. The OE System will be used in mode 1 and mode 2 without optical magnification, to obtain an overview of the gastric body and identify any gross changes in the mucosa, then optical magnification will be implemented.

Diagnostic Test: High-definition magnification with digital chromoendoscopy.

Interventions

High-Definition white light endoscopy.DIAGNOSTIC_TEST

evaluation of the gastric mucosa with high-definition white light endoscopy (EG-29i10 gastroscope and EPKi7010 video processor). The endoscopy images will be seen on a 27inch, flat panel, high definition LCD monitor (Radiance™ ultraSC-WU27-G1520 model) by

High-Definition white light endoscopy.
High-definition magnification with digital chromoendoscopy.DIAGNOSTIC_TEST

Subject will be evaluated by upper endoscopy with the OE System (EPK-i7010 HD Video Processor and MagniView™ EG-2990Zi Video Gastroscope) with intravenous sedation in a standardized manner. This technique involves the use of a distal black rubber hood (OE-A58; Pentax) at the tip of the endoscope, to fix the distance between the tip of the endoscope and the gastric mucosa at 2 mm. The OE System will be used in mode 1 and mode 2 without optical magnification, to obtain an overview of the gastric body and identify any gross changes in the mucosa, then optical magnification will be implemented.

High-definition magnification with digital chromoendoscopy.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A sample size was estimated with a 95% confidence interval and a 10% margin of error, based on the results of C. Robles et al. All consecutive participants will have dyspepsia according to the Rome IV criteria, and needs to be ≥18 years old. Participants need to have an epigastric pain syndrome (defined as localized pain or burning pain in the upper abdomen at least once a week, which was intermittent, nongeneralized, not relieved by defecation, and did not meet the criteria for pathology of the gallbladder or sphincter of Oddi); and/or a postprandial distress syndrome (defined as the presence of a nagging feeling of postprandial fullness after normal-volume meals, and/or early satiety that prevented the completion of a regular meal several times a week). The criteria need to be present within the 3 months prior to enrolment, and to have started ≥6 months prior to diagnosis of dyspepsia.

You may qualify if:

  • above 18 years of age
  • agreed to participate in the study
  • patients with dyspepsia in accordance with Rome criteria

You may not qualify if:

  • those taking NSAIDS, PPIs or antibiotics three weeks prior invitation
  • severe uncontrolled coagulopathy
  • prior history of gastric surgery
  • those pregnant or nursing females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ecuadorian Institute of Digestive Diseases

Guayaquil, Guayas, 090505, Ecuador

Location

Related Publications (2)

  • Hussain I, Ang TL. Evidence based review of the impact of image enhanced endoscopy in the diagnosis of gastric disorders. World J Gastrointest Endosc. 2016 Dec 16;8(20):741-755. doi: 10.4253/wjge.v8.i20.741.

    PMID: 28042388BACKGROUND

  • Robles-Medranda C, Valero M, Puga-Tejada M, Oleas R, Baquerizo-Burgos J, Soria-Alcivar M, Alvarado-Escobar H, Pitanga-Lukashok H. High-definition optical magnification with digital chromoendoscopy detects gastric mucosal changes in dyspeptic-patients. World J Gastrointest Endosc. 2020 Jan 16;12(1):23-32. doi: 10.4253/wjge.v12.i1.23.

    PMID: 31942231BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Gastric mucosa

MeSH Terms

Conditions

Gastritis, AtrophicGastritis

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 5, 2020

Study Start

March 1, 2020

Primary Completion

October 1, 2020

Study Completion

November 15, 2020

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

EC(1)