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Diagnostic Performance Indicators in Upper GI Endoscopy:PROSPERO Study (PROSPERO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Cambridge University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Massimiliano di Pietro, MD, University of Cambridge

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.


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

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. Interobserver agreement among expert and not expert endoscopists [ Time Frame: 1 year ]
    Agreement will be assess with Cohen kappa values

  8. 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
Clinical samples from biopsies taken during endoscopic procedures for the purpose of tissue diagnosis


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Massimiliano Di Pietro, MD 01223763349 md460@mrc-cu.cam.ac.uk
Contact: Bincy Alias 01223763994 ba323@medschl.cam.ac.uk

Sponsors and Collaborators
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Study Chair: Massimiliano Di Pietro, MD MRC Cancer Unit,Hutchison/MRC Research Centre
Principal Investigator: Ines Modolell, MD Cambridge University Hospitals
Principal Investigator: Andreas V Hadjinicolaou Cambridge University Hospitals
Publications:

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Responsible Party: Massimiliano di Pietro, MD, Senior Clinical Investigator Scientist, University of Cambridge
ClinicalTrials.gov Identifier: NCT04843397    
Other Study ID Numbers: PROSPERO_protocol v1.0
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Massimiliano di Pietro, MD, University of Cambridge:
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
Additional relevant MeSH terms:
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Stomach Neoplasms
Esophageal Neoplasms
Adenoma
Barrett Esophagus
Duodenal Neoplasms
Gastritis, Atrophic
Metaplasia
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Precancerous Conditions
Gastritis
Gastroenteritis
Intestinal Neoplasms
Duodenal Diseases
Intestinal Diseases