Preventing gallbladder stones in patients with midgut neuroendocrine tumors undergoing surgery
Effectiveness of Prophylactic Cholecystectomy in Patients With Midgut Neuroendocrine Tumor (Jejunum, Ileum or Proximal Colon) Who Require Primary Tumor Surgery. Randomized, Proof of Concept Clinical Trial.
This study tests whether removing the gallbladder during surgery for midgut neuroendocrine tumors can help prevent gallstones in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitari de Bellvitge Academic / other |
| Locations | 6 sites (Badalona, Barcelona and 5 other locations) |
| Trial ID | NCT04735198 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a confirmed diagnosis of midgut neuroendocrine tumors that are treatable with surgery.
Not a fit: Patients with neuroendocrine tumors located outside the jejunum, ileum, or proximal colon, or those with existing biliary stone disease, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of biliary stone disease in patients undergoing surgery for midgut neuroendocrine tumors.
How similar studies have performed: While there is limited literature on this specific approach, recommendations for prophylactic cholecystectomy exist, indicating potential for success based on expert consensus.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Badalona, Barcelona and 5 other locations
- Hospital Universitari Trias i Pujol — Badalona, Barcelona, Spain (Not_yet_recruiting)
- IDIBELL, Hospital Universitari de Bellvitge. — Barcelona, Barcelona, Spain (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.