NCT04735198
Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery.
Recruiting · Not Applicable · Hospital Universitari de Bellvitge · registry updated 2025-05-20
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
Inclusion
- 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.
- Neuroendocrine tumors located in any of the aforementioned locations.
- Presence or not of distant metastasis.
Exclusion
- 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.
- Patients who are candidate to liver resection or liver transplant.
- Patients with a gallbladder polyp bigger than 6 mm.