Status:
RECRUITING
Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery.
Lead Sponsor:
Hospital Universitari de Bellvitge
Conditions:
Midgut Carcinoid Tumor
Biliary Stones
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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. Whe...
Detailed Description
Title: Effectiveness of prophylactic cholecystectomy in patients with midgut neuroendocrine tumor (jejunum, ileum or proximal colon) who require primary tumor surgery. Randomized, proof of concept cli...
Eligibility Criteria
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.
- Presencié or not of gallstones.
- Capacity of follow up.
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.
- 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.
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04735198
Start Date
January 20 2021
End Date
February 28 2026
Last Update
May 20 2025
Active Locations (6)
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1
Hospital Universitari Trias i Pujol
Badalona, Barcelona, Spain
2
IDIBELL, Hospital Universitari de Bellvitge.
Barcelona, Barcelona, Spain, 08907
3
Hospital del Mar
Barcelona, Barcelona, Spain
4
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain