Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04918472
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2021-06-03
Brief Title:
Minimally Invasive Evaluation of Dyspepsia by Combined Magnetically Controlled Capsule Endoscopy and Urea Breath Test a Pilot Prospective Cohort Study
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Minimally Invasive Evaluation of Dyspepsia by Combined Magnetically Controlled Capsule Endoscopy and Urea Breath Test a Pilot Prospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MCUDYSPEPSIA
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
Detailed Description:
Dyspepsia affects about 20 of the population globally and represents one of the commonest reasons for patients to seek medical consultation1-3 The definition of dyspepsia has evolved over time and generally encompasses a variety of upper gastrointestinal UGI symptoms that can be of anatomical or functional origin such as epigastric pain or burning bloating postprandial fullness belching early satiety and nausea2 4 While diagnostic criteria eg Rome IV criteria have been proposed to better characterize and standardize symptoms of functional dyspepsia for research purpose there is considerable overlap of clinical presentation between functional dyspepsia and organic anatomical causes of dyspeptic symptoms such as peptic ulcer disease PUD gastroesophageal reflux disease GERD UGI malignancies or pancreatobiliary diseases2 3 5 6 Therefore it is of clinical importance to differentiate clinically significant anatomical pathologies from functional disorders during the initial evaluation of patients with dyspeptic symptoms
Society guidelines based on Western population data with a relatively lower prevalence of helicobacter pylori HP and UGI cancers eg cancer of stomach esophagus generally recommend an initial noninvasive management approach eg test and treat strategy for HP and empiric trial of acid suppressive therapy in dyspeptic patients without alarming symptoms or age 50 - 60 and reserve upfront endoscopy for high-risk patients with alarming symptoms eg gastrointestinal bleeding iron deficiency anemia dysphagia unintended weight loss etc or age 50 - 602 3 However in Asian populations with a relatively higher prevalence of HP and UGI cancers an initial noninvasive management approach to dyspeptic symptoms based on alarming symptoms and age cutoff at 50 - 60 years may not be entirely appropriate since up to 25 of patients with UGI cancers may not have alarming symptoms7 In a recent systematic review with meta-analysis of dyspepsia management in Asian countries alarming symptoms and age were found to be poor predictors of UGI cancers and 178 of dyspeptic patients who were eventually diagnosed with UGI cancers were younger than age 456
In a study of 5066 UGI endoscopies performed in Asian patients with dyspepsia clinically significant structural pathologies PUD cancers of stomach esophagus esophagitis were found in 195 of patients8 Although UGI endoscopy is the gold standard for diagnosis of clinically significant structural pathologies and HP infection by histology it is an invasive procedure with a small but finite risk of complication3 When compared to the invasive nature of conventional UGI endoscopy an initial minimally invasive diagnostic approach that can evaluate for both UGI structural pathology and HP infection would be highly desirable and clinically relevant in Asian patients with uninvestigated dyspepsia between 35 to 60 years of age
Wireless capsule endoscopy CE commonly known to the general public as the pill camera represents a minimally invasive diagnostic modality for visualization of the gastrointestinal GI tract and is well tolerated by patients9 While conventional CE has been shown to provide adequate visualization of luminal pathologies in the small bowel colon and esophagus visualization of the different parts of stomach by conventional CE remains challenging due to its passive propulsion through the GI tract by peristalsis or gravity and the large cavity size of the stomach Recently magnetically controlled capsule endoscopy MCCE systems comprised of small capsule endoscope guidance magnet robot data recorder and computer workstation for real-time viewing and control of CE have become available and can provide a more controlled visualization of different anatomical parts of the stomach by CE10 11 In a study of 350 patients with UGI symptoms requiring conventional UGI endoscopy for evaluation MCCE was shown to be safe and was able to provide adequate visualization of the stomach with a high sensitivity 904 and specificity 947 for focal gastric lesions when compared with conventional UGI endoscopy11 However despite its promising role as a minimally invasive diagnostic modality for structural pathologies of stomach MCCE does not allow tissue acquisition and thus cannot provide information on HP infection status by rapid urease test RUT or histological examination On the other hand noninvasive test for HP by urea breath test UBT has been shown to be highly sensitive and specific for HP infection and can supplement MCCE to provide important information on the status of HP infection12
To date there has been no dedicated study on the use of combined MCCE and UBT for minimally invasive evaluation of dyspepsia in Asian population In order to address the gap in knowledge we would like to propose a pilot prospective cohort study to investigate the clinical utility of combined MCCE and UBT as the initial minimally invasive evaluation of uninvestigated dyspepsia in Hong Kong patients between 35 to 60 years of age
Society guidelines based on Western population data with a relatively lower prevalence of helicobacter pylori HP and UGI cancers eg cancer of stomach esophagus generally recommend an initial noninvasive management approach eg test and treat strategy for HP and empiric trial of acid suppressive therapy in dyspeptic patients without alarming symptoms or age 50 - 60 and reserve upfront endoscopy for high-risk patients with alarming symptoms eg gastrointestinal bleeding iron deficiency anemia dysphagia unintended weight loss etc or age 50 - 602 3 However in Asian populations with a relatively higher prevalence of HP and UGI cancers an initial noninvasive management approach to dyspeptic symptoms based on alarming symptoms and age cutoff at 50 - 60 years may not be entirely appropriate since up to 25 of patients with UGI cancers may not have alarming symptoms7 In a recent systematic review with meta-analysis of dyspepsia management in Asian countries alarming symptoms and age were found to be poor predictors of UGI cancers and 178 of dyspeptic patients who were eventually diagnosed with UGI cancers were younger than age 456
In a study of 5066 UGI endoscopies performed in Asian patients with dyspepsia clinically significant structural pathologies PUD cancers of stomach esophagus esophagitis were found in 195 of patients8 Although UGI endoscopy is the gold standard for diagnosis of clinically significant structural pathologies and HP infection by histology it is an invasive procedure with a small but finite risk of complication3 When compared to the invasive nature of conventional UGI endoscopy an initial minimally invasive diagnostic approach that can evaluate for both UGI structural pathology and HP infection would be highly desirable and clinically relevant in Asian patients with uninvestigated dyspepsia between 35 to 60 years of age
Wireless capsule endoscopy CE commonly known to the general public as the pill camera represents a minimally invasive diagnostic modality for visualization of the gastrointestinal GI tract and is well tolerated by patients9 While conventional CE has been shown to provide adequate visualization of luminal pathologies in the small bowel colon and esophagus visualization of the different parts of stomach by conventional CE remains challenging due to its passive propulsion through the GI tract by peristalsis or gravity and the large cavity size of the stomach Recently magnetically controlled capsule endoscopy MCCE systems comprised of small capsule endoscope guidance magnet robot data recorder and computer workstation for real-time viewing and control of CE have become available and can provide a more controlled visualization of different anatomical parts of the stomach by CE10 11 In a study of 350 patients with UGI symptoms requiring conventional UGI endoscopy for evaluation MCCE was shown to be safe and was able to provide adequate visualization of the stomach with a high sensitivity 904 and specificity 947 for focal gastric lesions when compared with conventional UGI endoscopy11 However despite its promising role as a minimally invasive diagnostic modality for structural pathologies of stomach MCCE does not allow tissue acquisition and thus cannot provide information on HP infection status by rapid urease test RUT or histological examination On the other hand noninvasive test for HP by urea breath test UBT has been shown to be highly sensitive and specific for HP infection and can supplement MCCE to provide important information on the status of HP infection12
To date there has been no dedicated study on the use of combined MCCE and UBT for minimally invasive evaluation of dyspepsia in Asian population In order to address the gap in knowledge we would like to propose a pilot prospective cohort study to investigate the clinical utility of combined MCCE and UBT as the initial minimally invasive evaluation of uninvestigated dyspepsia in Hong Kong patients between 35 to 60 years of age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None