Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis (FAP)

Overview

Background and study aim The relative risks of duodenal adenocarcinoma and ampullary carcinoma in Familial Adenomatous Polyposis (FAP) have been estimated 100 to 330 times higher than in general population. However risk factors, including a genotype-phenotype association for duodenal cancer in FAP has not been fully understood. The aim of this study is to determine risk factors associated with the development of advanced duodenal polyposis and ampullary adenomas in colectomized patients with FAP.

Full Title of Study: “Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis: A Prospective Clinical, Immunopathologic and Molecular Analysis”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2016

Interventions

  • Procedure: Duodenoscopy and enteroscopy
    • All patients will undergo duodenoscopy and classified according to Spigelman. Patients classified as Spigelman III and IV will undergo enteroscopy.
  • Genetic: Molecular analysis.
    • DNA analysis

Clinical Trial Outcome Measures

Primary Measures

  • Genetic profile in FAP patients
    • Time Frame: one year

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with Familial Adenomatous Polyposis with colectomy, or scheduled for surgery. Exclusion Criteria:

  • Pregnancy, lactation

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marianny Sulbaran, GI endoscopist, ongoing MSc, PhD – University of Sao Paulo
  • Overall Official(s)
    • Marianny Sulbaran, MD, Principal Investigator, PhD
  • Overall Contact(s)
    • Marianny Sulbaran, MD, 5511 948526841, mariannysulbaran@gmail.com

References

Campos FG, Sulbaran M, Safatle-Ribeiro AV, Martinez CA. Duodenal adenoma surveillance in patients with familial adenomatous polyposis. World J Gastrointest Endosc. 2015 Aug 10;7(10):950-9. doi: 10.4253/wjge.v7.i10.950.

Spigelman AD, Talbot IC, Penna C, Nugent KP, Phillips RK, Costello C, DeCosse JJ. Evidence for adenoma-carcinoma sequence in the duodenum of patients with familial adenomatous polyposis. The Leeds Castle Polyposis Group (Upper Gastrointestinal Committee). J Clin Pathol. 1994 Aug;47(8):709-10. doi: 10.1136/jcp.47.8.709.

Groves CJ, Saunders BP, Spigelman AD, Phillips RK. Duodenal cancer in patients with familial adenomatous polyposis (FAP): results of a 10 year prospective study. Gut. 2002 May;50(5):636-41. doi: 10.1136/gut.50.5.636.

Mathus-Vliegen EM, Boparai KS, Dekker E, van Geloven N. Progression of duodenal adenomatosis in familial adenomatous polyposis: due to ageing of subjects and advances in technology. Fam Cancer. 2011 Sep;10(3):491-9. doi: 10.1007/s10689-011-9433-2.

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