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Endoscopic Characteristics of Duodenal and Ampullary Lesions

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01556399
Acronym
DUO/AMP-LST
Enrollment
350
Registered
2012-03-16
Start date
2011-11-30
Completion date
2018-11-30
Last updated
2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duodenal Diseases

Keywords

Duodenal adenoma, Ampullary adenoma

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.

Interventions

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

Sponsors

Professor Michael Bourke
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Significant differences in molecular abnormalities.Specimens will be stored and used for up to 15 yearsThe 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.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026