Preventing gallbladder stones in patients with midgut neuroendocrine tumors undergoing surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of prophylactic cholecystectomy in patients diagnosed with midgut neuroendocrine tumors who require primary tumor surgery. The study aims to evaluate the incidence of biliary stone disease in these patients, as both surgical and medical treatments may increase the risk of gallstone formation. It is a multicentric, open-label, randomized trial involving six hospitals, with participants assigned to either receive only primary tumor surgery or surgery combined with cholecystectomy. The follow-up period will last for two years to assess outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• IDIBELL, Hospital Universitari de Bellvitge.
  Barcelona, Barcelona, Spain Recruiting
• Hospital Universitari Trias i Pujol
  Badalona, Barcelona, Spain Not yet recruiting
• Hospital del Mar
  Barcelona, Barcelona, Spain Not yet recruiting
• Hospital Universitari Vall d'Hebron
  Barcelona, Barcelona, Spain Not yet recruiting
• Instituto Catalán de Oncología
  L'Hospitalet de Llobregat, Barcelona, Spain Active not recruiting
• Hospital Universitario Gregorio Marañón
  Madrid, Madrid, Spain Not yet recruiting

Study contacts

• Principal investigator: Ricardo Frago Montanuy — Hospital Universitari de Bellvitge
• Study coordinator: Inés Ginot
• Email: inesginot@gmail.com
• Phone: 696014147

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.