Background: Gastro-duodenal polyps develop in up to 90% of familial ad
enomatous polyposis (FAP) patients and periampullary carcinoma is one
of the most common extra-colonic malignancies in this syndrome. Periam
pullary adenomas have been shown to be precursor lesions to periampull
ary carcinoma. Sulindac, a non-steroidal anti-inflammatory drug, has b
een reported to cause regression of rectal polyps in FAP patients, how
ever its role in periampullary polyp regression is unclear. Methods: I
n May 1993, a prospective study was begun to evaluate the role of suli
ndac in prevention of polyp recurrence after resection of large (>1 cm
) duodenal polyps in FAP patients. Eight patients, mean age 50 years (
range 35 to 65), with documented large periampullary polyps were place
d on sulindac 150 mg twice daily. Prior to enrolment, all patients had
their large polyps removed from the periampullary region by intervent
ional endoscopy or by surgery. All patients had multiple small residua
l duodenal polyps. Follow-up was performed by one experienced endoscop
ist with a side-viewing video endoscope. Endoscopy was performed 6 mon
thly. Median follow-up time was 17.5 months (range 10 to 24 months). R
esults: In 3 patients, sulindac was discontinued due to side effects:
abdominal cramps (n = 3) and upper G-I bleeding (n = 1). None of the p
atients had regression of small periampullary polyps. In addition, one
patient developed an invasive periampullary carcinoma while on sulind
ac and 3 patients developed large recurrent periampullary polyps requi
ring further treatment. Summary: In our experience, sulindac is of no
significant benefit for the control of periampullary polyps in FAP. Ef
fective medical treatment of these polyps is still lacking.