Endoscopic Characteristics of Duodenal and Ampullary Lesions

Study Overview
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Brief Summary
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The purpose is to investigate whether polyps that look different at endoscopy, have formed via different mutations and have different risks of turning into cancer.

Detailed Description
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Laterally spreading tumours (LSTs), are polyps that have a lateral extension along the duodenal wall with minimal vertical growth. It has become evident over the last few years that rather than being a single entity requiring an accumulation of mutations, Duodenal and ampullary cancer is in fact a heterogenous disease forming via multiple distinct genetic pathways. It is therefore hypothesised that different polyp types have different genetic abnormalities, and potentially form via distinct genetic pathways, although this theory has not been widely examined. This knowledge would be important in furthering our understanding of the development of cancer. There is accumulating evidence that genetic abnormalities may be a better predictor of cancer behaviour than histological grade. Additionally, guidelines for endoscopy surveillance are currently a one size fits all approach that do not reflect the genetic heterogeneity of the disease and the knowledge that only 5% of polyps progress to cancer. Genetic studies may assess future cancer risk to a person in polyps once removed and plan surveillance endoscopy frequency.

Official Title
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A Correlation of the Endoscopic Characteristics of Duodenal and Ampullary Laterally Spreading Tumours With Their Somatic or Germline Mutations.

Conditions
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Duodenal Diseases

Intervention / Treatment
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* Other: Tissue Sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intention to perform Endoscopic Mucosal Resection Adenoma equal to or greater than 20mm over 18 years of age Able to give informed consent to involvement in trial Exclusion Criteria: Pregnancy Lactation: currently breastfeeding Taken clopidogrel within 7 days Taken warfarin within 5 days Had full therapeutic dose unfractionated heparin within 6 hours Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours Known clotting disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Duodenal adenomas<br>Patients who consent to participate in this study will have a small sample of their adenoma and normal tissue sent for molecular testing. | Other: Tissue Sampling<br>* A small sample of the duodenal adenoma will be obtained for molecular testing. The remaining adenoma will be sent for regular histological testing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant differences in molecular abnormalities. | The aim of this project is to look for statistically significant differences in molecular abnormalities from the three known genetic pathways, between the two different morphological types, granular and non-granular, to potentially demonstrate that these different polyps form via different genetic pathways. | Specimens will be stored and used for up to 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Duodenal adenoma, Ampullary adenoma