Clinical trial · Observational
Diagnostic Performance Indicators in Upper GI Endoscopy:PROSPERO Study
PROspective Multicentre Study to Identify Diagnostic Key PERfOrmance Indicators in Upper GI Endoscopy (PROSPERO)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Barretts Esophagus With Dysplasia | — | UNRESOLVED | — |
| Duodenal Adenoma | Duodenal Non-Ampullary Adenoma | ALIAS | 0.90 |
| Duodenum Cancer | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Dysplasia | Esophageal Intraepithelial Neoplasia | ALIAS | 0.90 |
| Gastric Atrophy | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Single Arm
- description
- Patients referred for clinically indicated EGD, without known precancerous condition. Patients will receive endoscopy with standardised biopsy and photodocumentation protocol
Primary outcomes (1)
- measure
- Define the prevalence of pre-malignant upper GI tract lesions as measured by standardised endoscopy and biopsy protocol
- timeFrame
- 1 year
- description
- 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.
Secondary outcomes (8)
- measure
- Missed rate of endoscopic diagnosis compared to pathological diagnosis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Able to read, comprehend, and complete the consent form 2. Aged ≥18 3. Clinically fit for endoscopy 4. Referred for endoscopy via any clinical pathway Exclusion Criteria: 1. Known upper GI conditions with or without ongoing endoscopic monitoring including Barrett's oesophagus, oesophageal dysplasia, gastric ulcers, duodenal polyps or any established upper GI malignancy 2. Previous oesophagectomy, gastrectomy for malignant disease 3. OGD performed within last 3 years of study initiation 4. Oesophageal stricture precluding completion of diagnostic endoscopic examination 5. Coagulopathy or anticoagulant/antiplatelet therapy for high risk conditions making non possible to discontinue the medication
References
Publications (16)
- BACKGROUNDRees CJ, Thomas Gibson S, Rutter MD, Baragwanath P, Pullan R, Feeney M, Haslam N; British Society of Gastroenterology, the Joint Advisory Group on GI Endoscopy, the Association of Coloproctology of Great Britain and Ireland. UK key performance indicators and quality assurance standards for colonoscopy. Gut. 2016 Dec;65(12):1923-1929. doi: 10.1136/gutjnl-2016-312044. Epub 2016 Aug 16. PMID 27531829
- BACKGROUNDKaminski MF, Regula J, Kraszewska E, Polkowski M, Wojciechowska U, Didkowska J, Zwierko M, Rupinski M, Nowacki MP, Butruk E. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med. 2010 May 13;362(19):1795-803. doi: 10.1056/NEJMoa0907667. PMID 20463339
- BACKGROUNDTai FWD, Wray N, Sidhu R, Hopper A, McAlindon M. Factors associated with oesophagogastric cancers missed by gastroscopy: a case-control study. Frontline Gastroenterol. 2019 Jul 11;11(3):194-201. doi: 10.1136/flgastro-2019-101217. eCollection 2020. PMID 32419910
- BACKGROUNDTeh JL, Tan JR, Lau LJ, Saxena N, Salim A, Tay A, Shabbir A, Chung S, Hartman M, So JB. Longer examination time improves detection of gastric cancer during diagnostic upper gastrointestinal endoscopy. Clin Gastroenterol Hepatol. 2015 Mar;13(3):480-487.e2. doi: 10.1016/j.cgh.2014.07.059. Epub 2014 Aug 10. PMID 25117772
- BACKGROUNDPark JM, Huo SM, Lee HH, Lee BI, Song HJ, Choi MG. Longer Observation Time Increases Proportion of Neoplasms Detected by Esophagogastroduodenoscopy. Gastroenterology. 2017 Aug;153(2):460-469.e1. doi: 10.1053/j.gastro.2017.05.009. Epub 2017 May 10. PMID 28501581
- BACKGROUNDGupta N, Gaddam S, Wani SB, Bansal A, Rastogi A, Sharma P. Longer inspection time is associated with increased detection of high-grade dysplasia and esophageal adenocarcinoma in Barrett's esophagus. Gastrointest Endosc. 2012 Sep;76(3):531-8. doi: 10.1016/j.gie.2012.04.470. Epub 2012 Jun 23. PMID 22732877