RecruitingACTRN12612000468820

Capsule endoscopy in the detection of small bowel neoplasias in patients with Lynch syndrome

Patients with Lynch syndrome with an identified mutation in a MMR gene will perform capsule endoscopy to evaluate the prevalence of small bowel neoplasias


Sponsor

Instituto Portugues de Oncologia de Lisboa. EPE

Enrollment

59 participants

Start Date

May 9, 2012

Study Type

Observational

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

This study is using a small swallowable camera called a capsule endoscope to check the small bowel (small intestine) of people with Lynch syndrome for early signs of bowel tumors or growths. Lynch syndrome is an inherited condition that significantly raises the risk of certain cancers including bowel cancer. This study aims to find out how common small bowel growths are in people with Lynch syndrome who have no symptoms. You may be eligible if: - You are 40 years of age or older - You have a confirmed mismatch repair gene mutation (a marker of Lynch syndrome) - You are able to give written informed consent You may NOT be eligible if: - You have symptoms of a bowel blockage - You have had unexplained weight loss in the last 2 months Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 p

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.


Locations(1)

-, Portugal

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