Capsule Endoscopy to Screen for Small Bowel Neoplasia in Lynch Syndrome (CELSIUS)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Erasmus Medical Center
Leiden University Medical Center
St. Antonius Hospital
The Netherlands Cancer Institute
University Medical Center Nijmegen
Maastricht University Medical Center
Free University Medical Center
Given Imaging Ltd.
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00898768
First received: May 11, 2009
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Lynch Syndrome
Small Bowel Neoplasia
Procedure: Capsule endoscopy
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Capsule Endoscopy in Lynch Syndrome for Small Intestinal Tumor Screening

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • The main outcome measure will be the number of neoplastic small bowel lesions, with determination of size, location and histological characteristics at baseline and at follow-up after 2 years. [ Time Frame: At baseline and at 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary endpoint will be the number of complications following endoscopic procedures: rates of capsule retention and postpolypectomy bleeding and perforation. [ Time Frame: At baseline and at 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: May 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Capsule endoscopy
    Capsule endoscopy at baseline and after 2 years
    Other Name: Capsule endoscopy PillCamSB
Detailed Description:

Lynch syndrome (LS), or hereditary nonpolyposis colorectal cancer (HNPCC), is an autosomal dominantly inherited 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. LS is caused by germline mutations in one of the mismatch repair (MMR) genes, mostly hMLH1, hMSH2 and hMSH6. Recently, several studies, including one from the Netherlands, have evaluated the life-time risk of small bowel cancer (SBC) in LS patients. From these studies the life-time risk of SBC is estimated around 4%. This is similar to the life-time risk of colorectal cancer in the general population, for which screening is generally advised. The risk of SBC increases with age, with an estimated prevalence of 1:500 at the age of 40, rising to an estimated prevalence of around 1:70 at the age of 60. Compared with the general population, LS patients with SBC generally present 10-20 years earlier as most patients with sporadic SBC are in their sixth or seventh decade of life. The localisation of SBC in LS is almost equal in the duodenum and jejunum, with localisation in the ileum generally occurring at a lower frequency.Until now, screening for small bowel neoplasia in Lynch syndrome patients is generally not recommended. However, the development of two new techniques to visualize the small intestine has raised the question whether screening might be useful and advisable. Small bowel capsule endoscopy (CE) has been developed as a safe, patient-friendly, minimally invasive modality for visualization of the small bowel. In addition, double-balloon enteroscopy (DBE) has been developed, a technique which allows endotherapeutic interventions. The diagnostic yields of both techniques are markedly higher than the conventional methods, such as push-enteroscopy and enteroclysis. To date, no study has been performed on screening for small bowel neoplasia in Lynch syndrome patients by means of these techniques.

The primary 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.

Secondary objectives:

The secondary aim is to identify risk factors for small bowel pathology useful in clinical practice to identify patients that might benefit from screening and to determine the additional interventional risk associated with the endoscopic procedures.

This is a national multi-centre study evaluating the yield of small bowel screening using capsule endoscopy and double balloon enteroscopy 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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Asymptomatic proven mutation carriers, with a known mutation in the hMLH1, hMSH2 or hMSH6 gene.
  2. Age between 35 and 70 years.
  3. Written informed consent provided.

Exclusion Criteria:

  1. Subjects with a strong suspicion on a small bowel stricture.
  2. Subjects with previous small bowel surgery.
  3. Pregnancy.
  4. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898768

Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands
Sponsors and Collaborators
University Medical Centre Groningen
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Erasmus Medical Center
Leiden University Medical Center
St. Antonius Hospital
The Netherlands Cancer Institute
University Medical Center Nijmegen
Maastricht University Medical Center
Free University Medical Center
Given Imaging Ltd.
Investigators
Principal Investigator: Jan J Koornstra, MD PhD University Medical Centre Groningen
Principal Investigator: Jan H Kleibeuker, MD PhD University Medical Centre Groningen
Principal Investigator: Hans F Vasen, MD PhD Leiden University Medical Center
  More Information

No publications provided

Responsible Party: Dr Jan J Koornstra MD PhD, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT00898768     History of Changes
Other Study ID Numbers: CELSIUS, Dutch Cancer Society 2008-4187
Study First Received: May 11, 2009
Last Updated: January 11, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
Lynch syndrome
HNPCC
Capsule endoscopy
Small bowel cancer
Double balloon endoscopy

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 15, 2014