None listed
Conditions
Brief summary
The cumulative risk of small bowel neoplasias in patients with Lynch syndrome (LS) is of 4% (100 times higher than that of the normal population). Small bowel surveillance in patients with LS is not recommended in surveillance guidelines. Recent data from a study with a small number of patients capsule endoscopy detected small bowel neoplasias in 8,5% of asymptomatic patients with LS. We intend to perform a prospective observational uncontrolled study in asymptomatic LS patients older than 40 years. The main endpoint of the study is to access the prevalence of small bowel neoplasias using capsule endoscopy. All capsules will be read independently by two observers. All lesions detected will be evaluated by the two observers and a consensus will be reached. All patients with lesions considered to be relevant and related to the LS (polyps or tumours) will be submitted to double balloon endoscopy to evaluate the lesion and to obtain a specimen for histological examination.
Interventions
Capsule endoscopy will be performed according with standard method:
Small bowel preparation with 2 liters of polyethylene glycol (PEG) preparation. At 5 PM on the evening prior to capsule endoscopy patients will begin drinking an 8-ounce glass of the preparation fluid (in the gallon container) every fifteen minutes until all of the liquid is consumed;
Overnight fast;
Capsule endoscopy (Mirocam) will be swallowed in the day of the exam and pictures will be taken for 12 h and collected in a reco
Capsule endoscopy will be performed according with standard method: Small bowel preparation with 2 liters of polyethylene glycol (PEG) preparation. At 5 PM on the evening prior to capsule endoscopy patients will begin drinking an 8-ounce glass of the preparation fluid (in the gallon container) every fifteen minutes until all of the liquid is consumed; Overnight fast; Capsule endoscopy (Mirocam) will be swallowed in the day of the exam and pictures will be taken for 12 h and collected in a recorder. The capsule is eliminated in the feces and does not need to be recovered. The images are read in the appropriate software by an experienced physician.
Sponsors
Instituto Portugues de Oncologia de Lisboa. EPE
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Mismatch repair gene mutation; Give written informed consent; More than 40 years of age
Exclusion criteria
GI occlusive symptoms; unexplained weight loss in the last 2 months
Outcome results
None listed