HNPCC Lynch syndrome
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Asymptomatic proven mutation carriers, with a known mutation in the hMLH1, hMSH2 or hMSH6 gene - Age between 35 and 70 years - Written informed consent provided
Exclusion criteria
Exclusion criteria: - Subjects with a strong suspicion on a small bowel stricture. - Subjects with previous small bowel surgery - Pregnancy - Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endpoints The primary endpoint 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. Several characteristics of the lesions will be recorded. Size The size of all lesions encountered will be determined by the pathologist. Location The location of all lesions encountered will be recorded subdivided in duodenum, jejunum and ileum. Histology Biopsy samples and excised lesions will be examined by local pathologists with special interest in gastroenteropathology. Lesions will be classified according to the WHO criteria. Findings will be reported as normal mucosa, hyperplastic polyp, adenomatous polyp or carcinoma. Adenomatous polyps will be classified as serrated, tubular, tubulovillous or villous. Degree of dysplasia will be classified as low-grade or high-grade. Adenomatous polyps or cancer will be considered as neoplastic lesions. In addition, all lesions will be reviewed centrally by a pathologist (Prof Morreau, Leiden University Medical Centre). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint will be the number of complications following endoscopic procedures: rates of capsule retention and postpolypectomy bleeding and perforation. Immediate bleeding following polypectomy can usually be managed by epinephrin injection, application of electrocautery or hemoclips. Rates of immediate bleeding will be recorded. Postpolypectomy bleeding will be defined as delayed hemorrhage following the endoscopic procedure. Patients will be instructed about possible postpolypectomy bleeding and instructed to return to the emergency department. Postpolypectomy perforations usually present in a delayed manner, with abdominal pain and localised peritoneal signs. Most of these patients will recover with conservative therapy. Patients will be instructed about possible postpolypectomy perforation and instructed to return to the emergency department. | — |
Countries
Netherlands
Outcome results
None listed