Diagnostic Performance Indicators in Upper GI Endoscopy:PROSPERO Study

NCT04843397 | Unknown

• 1 other identifier: PROSPERO_protocol v1.0
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Esophageal Cancer; Gastric Cancer; Barrett Esophagus; Gastric Atrophy; Gastric Intestinal Metaplasia; Duodenal Adenoma; Esophageal Dysplasia; Duodenum Cancer; Gastric Polyp; Barretts Esophagus With Dysplasia

Keywords

upper GI endoscopy; esophagogastroduodenoscopy; esophageal cancer; gastric cancer; duodenal cancer; barretts esophagus; gastric polyp; premalignant upper GI lesions; upper GI cancer prevention; upper GI cancer early diagnosis; diagnostic upper GI endoscopy key performance indicators

Outcome Measures

Primary Outcomes (1)

• Define the prevalence of pre-malignant upper GI tract lesions as measured by standardised endoscopy and biopsy protocol

  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.

  1 year

Secondary Outcomes (8)

• Missed rate of endoscopic diagnosis compared to pathological diagnosis

  1 year

• Missed rate of endoscopic diagnosis compared to expert review of endoscopic photos

  1 year

• Correlation between duration of the endoscopy and detection of pre-neoplastic and neoplastic lesions

  1 year

• Quality of the endoscopic pictures taken in routine endoscopy

  1 year

• Correlation between prevalence of diagnoses and endoscopist experience

  1 year

Study Arms (1)

Single Arm

Patients referred for clinically indicated EGD, without known precancerous condition. Patients will receive endoscopy with standardised biopsy and photodocumentation protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient referred and clinically fit for endoscopy via any clinical referral pathway that is able to consent to study participation.

You may qualify if:

• Able to read, comprehend, and complete the consent form
• Aged ≥18
• Clinically fit for endoscopy
• Referred for endoscopy via any clinical pathway

You may not qualify if:

• 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
• Previous oesophagectomy, gastrectomy for malignant disease
• OGD performed within last 3 years of study initiation
• Oesophageal stricture precluding completion of diagnostic endoscopic examination
• Coagulopathy or anticoagulant/antiplatelet therapy for high risk conditions making non possible to discontinue the medication

Sponsors & Collaborators

• University of Cambridge: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Related Publications (16)

• Rees 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 BACKGROUND

• Kaminski 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 BACKGROUND

• Tai 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 BACKGROUND

• Teh 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 BACKGROUND

• Park 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 BACKGROUND

• Gupta 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 BACKGROUND

• Gerson LB, Shetler K, Triadafilopoulos G. Prevalence of Barrett's esophagus in asymptomatic individuals. Gastroenterology. 2002 Aug;123(2):461-7. doi: 10.1053/gast.2002.34748.

  PMID: 12145799 BACKGROUND

• Hirota WK, Loughney TM, Lazas DJ, Maydonovitch CL, Rholl V, Wong RK. Specialized intestinal metaplasia, dysplasia, and cancer of the esophagus and esophagogastric junction: prevalence and clinical data. Gastroenterology. 1999 Feb;116(2):277-85. doi: 10.1016/s0016-5085(99)70123-x.

  PMID: 9922307 BACKGROUND

• Ronkainen J, Aro P, Storskrubb T, Johansson SE, Lind T, Bolling-Sternevald E, Vieth M, Stolte M, Talley NJ, Agreus L. Prevalence of Barrett's esophagus in the general population: an endoscopic study. Gastroenterology. 2005 Dec;129(6):1825-31. doi: 10.1053/j.gastro.2005.08.053.

  PMID: 16344051 BACKGROUND

• Joo YE, Park HK, Myung DS, Baik GH, Shin JE, Seo GS, Kim GH, Kim HU, Kim HY, Cho SI, Kim N. Prevalence and risk factors of atrophic gastritis and intestinal metaplasia: a nationwide multicenter prospective study in Korea. Gut Liver. 2013 May;7(3):303-10. doi: 10.5009/gnl.2013.7.3.303. Epub 2013 May 13.

  PMID: 23710311 BACKGROUND

• Petersson F, Borch K, Franzen LE. Prevalence of subtypes of intestinal metaplasia in the general population and in patients with autoimmune chronic atrophic gastritis. Scand J Gastroenterol. 2002 Mar;37(3):262-6. doi: 10.1080/003655202317284156.

  PMID: 11916187 BACKGROUND

• Kim N, Park YS, Cho SI, Lee HS, Choe G, Kim IW, Won YD, Park JH, Kim JS, Jung HC, Song IS. Prevalence and risk factors of atrophic gastritis and intestinal metaplasia in a Korean population without significant gastroduodenal disease. Helicobacter. 2008 Aug;13(4):245-55. doi: 10.1111/j.1523-5378.2008.00604.x.

  PMID: 18665932 BACKGROUND

• den Hoed CM, van Eijck BC, Capelle LG, van Dekken H, Biermann K, Siersema PD, Kuipers EJ. The prevalence of premalignant gastric lesions in asymptomatic patients: predicting the future incidence of gastric cancer. Eur J Cancer. 2011 May;47(8):1211-8. doi: 10.1016/j.ejca.2010.12.012. Epub 2011 Jan 14.

  PMID: 21239166 BACKGROUND

• Taylor PR, Abnet CC, Dawsey SM. Squamous dysplasia--the precursor lesion for esophageal squamous cell carcinoma. Cancer Epidemiol Biomarkers Prev. 2013 Apr;22(4):540-52. doi: 10.1158/1055-9965.EPI-12-1347.

  PMID: 23549398 BACKGROUND

• Jepsen JM, Persson M, Jakobsen NO, Christiansen T, Skoubo-Kristensen E, Funch-Jensen P, Kruse A, Thommesen P. Prospective study of prevalence and endoscopic and histopathologic characteristics of duodenal polyps in patients submitted to upper endoscopy. Scand J Gastroenterol. 1994 Jun;29(6):483-7. doi: 10.3109/00365529409092458.

  PMID: 8079103 BACKGROUND

• Beg S, Ragunath K, Wyman A, Banks M, Trudgill N, Pritchard DM, Riley S, Anderson J, Griffiths H, Bhandari P, Kaye P, Veitch A. Quality standards in upper gastrointestinal endoscopy: a position statement of the British Society of Gastroenterology (BSG) and Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland (AUGIS). Gut. 2017 Nov;66(11):1886-1899. doi: 10.1136/gutjnl-2017-314109. Epub 2017 Aug 18.

  PMID: 28821598 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Clinical samples from biopsies taken during endoscopic procedures for the purpose of tissue diagnosis

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Barrett Esophagus; Gastritis, Atrophic; Duodenal Neoplasms; Polyposis, Gastric

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Precancerous Conditions; Gastritis; Gastroenteritis; Intestinal Neoplasms; Duodenal Diseases; Intestinal Diseases

Study Officials

• Massimiliano Di Pietro, MD

  MRC Cancer Unit,Hutchison/MRC Research Centre

  STUDY CHAIR

• Ines Modolell, MD

  Cambridge University Hospitals

  PRINCIPAL INVESTIGATOR

• Andreas V Hadjinicolaou

  Cambridge University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimiliano Di Pietro, MD

CONTACT

01223763349; md460@mrc-cu.cam.ac.uk

Bincy Alias

CONTACT

01223763994; ba323@medschl.cam.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Investigator Scientist

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: September 15, 2022
• Last Updated: April 15, 2021

Record last verified: 2021-04