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Prevention of Progression of Duodenal Adenomas to Cancer in Patients With Familial Adenomatous Polyposis (FAP)


Phase 2/Phase 3
18 Years
70 Years
Not Enrolling
Both
Familial Adenomatous Polyposis, Duodenal Neoplasms, Duodenal Polyps

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Trial Information

Prevention of Progression of Duodenal Adenomas to Cancer in Patients With Familial Adenomatous Polyposis (FAP)


Inclusion Criteria:



- Patients with Familial adenomatous Polyposis: APC-mutation identified or more than
100 colorectal polyps on diagnosis

- Spigelman score of duodenal adenoma equal to II or III

Exclusion Criteria:

- Incapability of signing informed consent

- Active gastric or duodenal ulcer, gastrointestinal bleeding

- Cardiovascular disease or risk:

- Congestive cardiac failure: NYHA class II to IV

- Proven ischemic heart disease and/or cerebrovascular disease

- Risk factors: hypertension, hyperlipidaemia, diabetes mellitus, family history
of cardiovascular events (≥2 first degree family members <55 years)

- Renal dysfunction: creatinine clearance below 50mL/min

- Liver dysfunction: albumin below 25 g/L or Child-Pugh-score equal to or below 10

- Known allergic reaction to sulfonamides, NSAIDs or ursodeoxycholic acid

- Use of NSAIDs or ursodeoxycholic acid for more than 1 week during the 6 months prior
to the start of the study

- Use of lithium

- Symptomatic gallstones

- Inflammatory bowel disease

- (Possible) pregnancy or breast feeding

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures)

Outcome Time Frame:

Baseline, 6 months

Safety Issue:

No

Principal Investigator

Fokko M Nagengast, MD, Ph D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Center St. Radboud Nijmegen, The Netherlands

Authority:

Netherlands: Medical Ethics Review Committee (METC)

Study ID:

RUN 2008-4198

NCT ID:

NCT00808743

Start Date:

May 2009

Completion Date:

January 2013

Related Keywords:

  • Familial Adenomatous Polyposis
  • Duodenal Neoplasms
  • Duodenal Polyps
  • Familial adenomatous polyposis
  • Adenomatous Polyposis Coli
  • Digestive System Neoplasms
  • Gastrointestinal Disease
  • Intestinal disease
  • Intestinal neoplasms
  • Gastrointestinal neoplasms
  • Polyps
  • Adenoma
  • Adenomatous Polyps
  • Neoplastic Syndromes, Hereditary
  • Digestive System Diseases
  • Genetic Diseases, Inborn
  • Chemoprevention
  • Celecoxib
  • Ursodeoxycholic acid
  • Anti-Inflammatory agents, Non-Steroidal
  • Cyclooxygenase Inhibitors
  • Adenoma
  • Neoplasms
  • Duodenal Neoplasms
  • Adenomatous Polyposis Coli
  • Polyps
  • Colorectal Neoplasms
  • Nasopharyngeal Neoplasms

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