Endoscopic Characteristics of Duodenal and Ampullary Lesions

NCT ID: NCT01556399

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2018-11-30

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.

Conditions

Duodenal Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Duodenal adenomas

Patients who consent to participate in this study will have a small sample of their adenoma and normal tissue sent for molecular testing.

Tissue Sampling

Intervention Type: OTHER

A small sample of the duodenal adenoma will be obtained for molecular testing. The remaining adenoma will be sent for regular histological testing.

Interventions

Tissue Sampling

A small sample of the duodenal adenoma will be obtained for molecular testing. The remaining adenoma will be sent for regular histological testing.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Professor Michael Bourke

OTHER

Sponsor Role: lead

Responsible Party

Professor Michael Bourke

Director of Gastrointestinal Endoscopy

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Bourke, MBBS, FRACP

Role: PRINCIPAL_INVESTIGATOR

Western Sydney Local Health District

Locations

Westmead Hospital

Westmead, New South Wales, Australia

Countries

Australia

Other Identifiers

LST-UGIM

Identifier Type: -

Identifier Source: org_study_id