Diagnostic Performance Indicators in Upper GI Endoscopy:PROSPERO Study (PROSPERO)
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|ClinicalTrials.gov Identifier: NCT04843397
Recruitment Status : Unknown
Verified April 2021 by Massimiliano di Pietro, MD, University of Cambridge.
Recruitment status was: Not yet recruiting
First Posted : April 13, 2021
Last Update Posted : April 15, 2021
Cancers of the upper gastro-intestinal tract, including esophagus (gullet), stomach and small bowel, are amongst the deadliest malignancies. The main reason for their high mortality rate is that they are usually diagnosed late when curative treatments are no longer effective. However, these types of cancer generally arise from well-described pre-cancerous diseases, such as Barrett's esophagus and gastric intestinal metaplasia. This provides an opportunity for clinicians to detect these pre-cancerous conditions early and offer adequate cure or clinical monitoring before they progress to cancer. A camera test (gastroscopy) is the gold-standard test to detect pre-cancerous diseases in these organs.
There has been limited research to set the standards for performance of a gastroscopy, especially with regards to diagnosis of pre-cancerous conditions, which require knowledge and skills by the physician performing the test (endoscopist). Therefore, the hypothesis behind this study is that the aforementioned pre-cancerous diseases are understudied and often go undetected. This study aims to understand how often endoscopists should diagnose these pre-cancerous diseases on routine gastroscopy and help define the standards to measure performance. The investigators will assess the following rates: i. how often endoscopists diagnose these pre-cancerous lesions during endoscopy; ii. How often these conditions are diagnosed on biopsies taken according to a standardized protocol; iii. How often these condition should have been diagnosed by the endoscopists based on the review of pictures by expert endoscopists. The investigators will also compare the rates of correct diagnosis by endoscopists with different levels of experience and based on the times spent to complete the diagnostic test.
Investigating these aspects will enhance the understanding of the medical community with regards to the diagnosis of these pre-cancerous lesions and set endoscopy standards to improve their early detection and treatment before they progress to cancer. This will translate to improved cancer prevention and benefit for patients.
|Condition or disease
|Esophageal Cancer Gastric Cancer Barrett Esophagus Gastric Atrophy Gastric Intestinal Metaplasia Duodenal Adenoma Esophageal Dysplasia Duodenum Cancer Gastric Polyp Barretts Esophagus With Dysplasia
|Study Type :
|Estimated Enrollment :
|PROspective Multicentre Study to Identify Diagnostic Key PERfOrmance Indicators in Upper GI Endoscopy (PROSPERO)
|Estimated Study Start Date :
|June 1, 2021
|Estimated Primary Completion Date :
|June 1, 2022
|Estimated Study Completion Date :
|September 15, 2022
Patients referred for clinically indicated EGD, without known precancerous condition. Patients will receive endoscopy with standardised biopsy and photodocumentation protocol
- Define the prevalence of pre-malignant upper GI tract lesions as measured by standardised endoscopy and biopsy protocol [ Time Frame: 1 year ]
The primary outcome is calculating the proportion of patients diagnosed with pre-malignant pathology in the upper GI tract. This is further broken down into categories of pre-malignant pathology, namely; 1) duodenal adenoma, 2) gastric atrophy/gastric intestinal metaplasia (IM), 3) gastric adenoma, 4) Barrett's oesophagus and 5) squamous dysplasia.
The detection rates of upper GI tract pre-malignant lesions in our study procedures will be compared to standard historical data currently available to update and guide future practice guidelines.
- Missed rate of endoscopic diagnosis compared to pathological diagnosis [ Time Frame: 1 year ](defined as any pathological diagnosis that was not suspected by the endoscopist on visualisation alone)
- Missed rate of endoscopic diagnosis compared to expert review of endoscopic photos [ Time Frame: 1 year ](defined as endoscopic lesions identified by expert review and not reported by primary endoscopist)
- Correlation between duration of the endoscopy and detection of pre-neoplastic and neoplastic lesions [ Time Frame: 1 year ]Assessment of whether duration of the endoscopy associates with diagnosis of pre-neoplastic lesions
- Quality of the endoscopic pictures taken in routine endoscopy [ Time Frame: 1 year ]defined as quantitative assessment of photo on a Visual Analogue Scale by expert endoscopists
- Correlation between prevalence of diagnoses and endoscopist experience [ Time Frame: 1 year ]Assessment of whether year of endoscopy practice correlate with the rate of detection of pre-malignant lesions
- Correlation between use of image enhanced endoscopy and rate of detection [ Time Frame: 1 year ]Assessment of whether use of dye or electronic chromoendoscopy improves detection of lesions
- Interobserver agreement among expert and not expert endoscopists [ Time Frame: 1 year ]Agreement will be assess with Cohen kappa values
- Correlation between life-style factors and pathological outcomes [ Time Frame: 1 year ]Assessment of utility of life-style information to predict diagnosis
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04843397
|Contact: Massimiliano Di Pietro, MD
|Contact: Bincy Alias
|Massimiliano Di Pietro, MD
|MRC Cancer Unit,Hutchison/MRC Research Centre
|Ines Modolell, MD
|Cambridge University Hospitals
|Andreas V Hadjinicolaou
|Cambridge University Hospitals