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

RecruitingNAAges 18 Years - anyAllHospital Universitari de Bellvitge
NCT04735198 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ra

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

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

6 sites
Hospital Universitari Trias i Pujol
Badalona, Spain
IDIBELL, Hospital Universitari de Bellvitge.
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Instituto Catalán de Oncología
L'Hospitalet de Llobregat, Spain
Hospital Universitario Gregorio Marañón
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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