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

Condition(s) studied

Investigational drug(s) / intervention(s)

Primary tumor surgery: Large bowel resection.

Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomy: Large bowel resection combined and cholecystectomy.

Study summary

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.

Eligibility

Primary outcome measure(s)

• To evaluate the rate of biliary stone disease associated to patients with midgut NET that have gone through primary tumor surgery. — Two years after the surgery
  Incidence of biliary stone disease in patients with midgut NET who requiere primary tumor surgery

Trial sites (6)

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