Minimally Invasive Evaluation of Dyspepsia by Combined Magnetically Controlled Capsule Endoscopy and Urea Breath Test: a Pilot Prospective Cohort Study

NCT04918472 | Completed DMC

• 1 other identifier: 2021.194
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The combined diagnostic accuracy of MCCE and UBT in Hong Kong patients with uninvestigated dyspepsia between age 35 to 60 years for structural pathology and HP infection is comparable to that of conventional UGI endoscopy with histological examination for HP

Conditions

Dyspepsia; Peptic Ulcer Disease; Gastroesophageal Reflux; Ugi Malignancies; Pancreatobiliary Disease

Outcome Measures

Primary Outcomes (1)

• The combined diagnostic accuracy of MCCE and UBT as gold standard

  The combined diagnostic accuracy of MCCE and UBT in Hong Kong patients with uninvestigated dyspepsia between age 35 to 60 years for structural pathology and HP infection using conventional UGI endoscopy and histological examination for HP as gold standard

  2 weeks

Secondary Outcomes (3)

• The sensitivity and specificity of MCCE for clinically significant structural pathology in UGI (defined as peptic ulcers, cancers, reflux esophagitis) as gold standard

  during endoscopy

• The sensitivity and specificity of UBT for HP infection in Hong Kong patients with uninvestigated dyspepsia between age 35 to 60 years using histological examination for HP by UGI endoscopy as gold standard

  during endoscopy

• Adverse events up to 2 weeks after UBT, MCCE, UGI endoscopy

  2 weeks after endoscopy

Study Arms (1)

MCCE

EXPERIMENTAL

Magnetically controlled capsule endoscopy will be performed before UGI endoscopy.

Procedure: MCCE

Interventions

MCCE PROCEDURE

Mangetically controlled capsule endoscopy will be performed

MCCE

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 35 to 60
• Patients with uninvestigated dyspeptic symptoms including epigastric pain or burning, bloating, postprandial fullness, belching, early satiety and nausea
• Patients who are able to provide written informed consent to participate in the study and comply with the study procedures.

You may not qualify if:

• Unable to provide written informed consent
• Patients with contraindications for conventional UGI endoscopy or MCCE due to comorbidities
• Patients with dysphagia, gastroparesis, gastrointestinal (GI) tract obstruction, or surgically altered anatomy of the GI tract
• Patients with a permanent pacemaker, or implantable cardioverter-defibrillator
• Patients with any electronic/magnetic/mechanically controlled devices e.g. sacral nerve stimulators, bladder stimulators
• Patients with known inflammatory bowel disease, cancer of the GI tract
• Patients who are pregnant or lactating

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Location

MeSH Terms

Conditions

Dyspepsia; Peptic Ulcer; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 8, 2021
• Study Start: August 6, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)