Endoscopic Characteristics of Duodenal and Ampullary Lesions

Completed

• Conditions: Duodenal Diseases
• Interventions: Other: Tissue Sampling

• Registration Number: NCT01556399
• Lead Sponsor: Professor Michael Bourke

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-03-15
• Study First Submitted QC: 2012-03-15
• Study First Posted: 2012-03-16
• Primary Completion: 2017-11
• Study Completion: 2018-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Duodenal adenomas	Tissue Sampling	Patients who consent to participate in this study will have a small sample of their adenoma and normal tissue sent for molecular testing.

Primary Outcome Measures

Name	Time	Method
Significant differences in molecular abnormalities.	Specimens will be stored and used for up to 15 years	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.

Trial Locations

Locations (1)

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia