Know Cancer

forgot password

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
Familial Adenomatous Polyposis, Duodenal Neoplasms, Duodenal Polyps

Thank you

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:


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:


Principal Investigator

Fokko M Nagengast, MD, Ph D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Center St. Radboud Nijmegen, The Netherlands


Netherlands: Medical Ethics Review Committee (METC)

Study ID:

RUN 2008-4198



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