Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis

Last updated: May 15, 2013
Sponsor: Radboud University
Overall Status: Completed

Phase

2/3

Condition

Colon Cancer

Digestive System Neoplasms

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT00808743
RUN 2008-4198
EudraCT: 2008-003696-43
ABR nr.: NL23569.091.08
CMO: 2008/148
  • Ages 18-70
  • All Genders

Study Summary

Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is to determine wether celecoxib combined with ursodeoxycholic acid is an effective chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in patients with FAP.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Spigelman score of duodenal adenoma equal to II or III

Exclusion

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 ofcardiovascular 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 priorto the start of the study

  • Use of lithium

  • Symptomatic gallstones

  • Inflammatory bowel disease

  • (Possible) pregnancy or breast feeding

Study Design

Total Participants: 37
Study Start date:
May 01, 2009
Estimated Completion Date:
January 31, 2013

Connect with a study center

  • Academic Medical Center

    Amsterdam,
    Netherlands

    Site Not Available

  • University Medical Center

    Groningen,
    Netherlands

    Site Not Available

  • Leiden University Medical Center

    Leiden,
    Netherlands

    Site Not Available

  • University Medical Center St. Radboud

    Nijmegen,
    Netherlands

    Site Not Available

  • Erasmus Medical Center

    Rotterdam,
    Netherlands

    Site Not Available

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