Capsule Endoscopy to Screen for Small Bowel Neoplasia in Lynch Syndrome

Summary

Lynch syndrome (LS), or hereditary nonpolyposis colorectal cancer (HNPCC), is a hereditary disorder characterized by a very high risk of early-onset colorectal and endometrial cancer and an increased risk of other cancers, including cancers of the stomach, ovary, urinary tract, hepatobiliary tract, pancreas and small bowel. This is a national multi-centre study evaluating the yield of small bowel screening using capsule endoscopy (CE) and double balloon enteroscopy (DBE) in Lynch syndrome subjects. The intervention consists of performing a capsule endoscopy procedure at baseline and at 2-year follow-up. In patients with polyps or malignant appearing abnormalities on capsule endoscopy, double balloon enteroscopy will be performed with subsequent endoscopic or surgical removal of neoplastic lesions. The aim of the study is to determine the prevalence and incidence of small bowel neoplasia in Lynch syndrome patients using small bowel CE and DBE.

Conditions

• Lynch Syndrome
• Small Bowel Neoplasia

Interventions

PROCEDURE

Capsule endoscopy

Capsule endoscopy at baseline and after 2 years

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• St. Antonius Hospital

  collaborator OTHER

• The Netherlands Cancer Institute

  collaborator OTHER

• University Medical Center Nijmegen

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Free University Medical Center

  collaborator OTHER

• Medtronic - MITG

  collaborator INDUSTRY

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• Jan J Koornstra, MD PhD · University Medical Center Groningen

• Jan H Kleibeuker, MD PhD · University Medical Center Groningen

• Hans F Vasen, MD PhD · Leiden University Medical Center

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

35 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-05-31

Primary Completion

2014-12-31

Completion

2014-12-31

Countries

• Netherlands

Study Locations