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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitari de Bellvitge

About this trial

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 criteria

Qualifiers

Patients must grant the informed consent written, signed and dated.

Male or female older than 18 years old.

Radiological or histological diagnose of midgut NET that can be treated with surgery.

In case of female with childbearing age (time between menarche and menopause), a pregnancy test with negative result.

Disqualifiers

Neuroendocrine tumors which are not located in jejunum or ileum (bronchial, gastric, pancreatic, descending colon, sigma or rectum.).

Patients that have gone through a previous bowel resection.

Patients with previous cholecystectomy.

Pacients with biliary stone disease.

Trial design

Treatments tested in this trial

  • Primary tumor surgery
  • Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomy

Treatment groups

100 Participants
are divided into 2 treatment groups