Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery.

The investigators want to study the effectiveness of prophylactic cholecystectomy in patients with midgut neuroendocrine tumor (jejunum, ileum or proximal colon) who require primary tumor surgery. When patients are diagnosed and are tributary to surgical treatment, the tumor might compromise vascularization, and patients need an extensive bowel resection. The patients might also receive medical treatment with somatostatin analogs. The combination of extensive bowel resection and medical treatment might increase gallbladder stones, but patients might not develop biliary stone disease, as in the general population, where 20% of the population have gallbladder stones but only a 10 to 15 % of the population will develop symptoms. The idea comes from the lack of literature about the incidence of biliary Stone disease in patients with midgut NET tumors. It's a multicentric, open-label and randomized clinical trial to evaluate the incidence of biliary stone disease in patients with midgut NET who require primary tumor surgery combined or not to cholecystectomy. Our hypothesis suggests that patients with midgut neuroendocrine tumor who require primary tumor resection without the combination of prophylactic cholecystectomy do not have an increased incidence of biliary stone disease two years after the surgery, regardless of treatment with SSA.

NCT Number	NCT04735198
Lead Sponsor	Hospital Universitari de Bellvitge
Conditions	Midgut Carcinoid Tumor, Biliary Stones
Enrollment	100 participants
Start Date	2021-01-20
Primary Completion	2025-12-01 (estimated)
Study Completion	2026-02-28 (estimated)
Updated on ClinicalTrials.gov	2025-05-20