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

Recruiting now · Not applicable

Conditions studied: Midgut Carcinoid Tumor, Biliary Stones

In brief

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.

Key facts

Study ID

NCT04735198

Run by

Hospital Universitari de Bellvitge

People needed

100

Starts

2021-01-20

Expected to finish

2026-02-28

Last updated by the study team

2025-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Presencié or not of gallstones.
• Capacity of follow up.

You may not qualify if…

• 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.
• Pacients with one gallbladder sessile polyp, presence of more than one polyp or patients older than 50 years old with a polyp.
• Refusal to participate.
• Patients with previous history of malignant neoplasms in the last 5 years, except skin basal cell carcinoma, "in situ" cervical carcinoma or in situ carcinoma found in a polyp removed with a colonoscopy.
• Medical criteria that doesn't consider the patient a candidate to participate in the study.

Where it is running

• IDIBELL, Hospital Universitari de Bellvitge. — Barcelona, Barcelona, Spain (enrolling)
• Hospital Universitari Trias i Pujol — Badalona, Barcelona, Spain
• Hospital del Mar — Barcelona, Barcelona, Spain
• Hospital Universitari Vall d'Hebron — Barcelona, Barcelona, Spain
• Instituto Catalán de Oncología — L'Hospitalet de Llobregat, Barcelona, Spain
• Hospital Universitario Gregorio Marañón — Madrid, Madrid, Spain

Full record on ClinicalTrials.gov

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