Actively Recruiting
Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery.
Led by Hospital Universitari de Bellvitge · Updated on 2025-05-20
100
Participants Needed
6
Research Sites
266 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must provide written informed consent
- Male or female aged over 18 years
- Radiological or histological diagnosis of midgut neuroendocrine tumor suitable for surgery
- Negative pregnancy test for women of childbearing age
- Tumor located in jejunum, ileum, or proximal colon
- Presence or absence of distant metastasis
- Presence or absence of gallstones
- Ability to comply with follow-up requirements
You will not qualify if you...
- Neuroendocrine tumors located outside jejunum or ileum (such as bronchial, gastric, pancreatic, descending colon, sigmoid, or rectal tumors)
- Previous bowel resection surgery
- Previous gallbladder removal (cholecystectomy)
- Existing biliary stone disease
- Candidates for liver resection or transplant
- Gallbladder polyp larger than 6 mm
- Presence of multiple gallbladder polyps or sessile polyp, or any polyp in patients over 50 years old
- Refusal to participate
- History of malignant neoplasms in the past 5 years, except certain skin or cervical cancers
- Medical reasons deeming patient unsuitable for the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Hospital Universitari Trias i Pujol
Badalona, Barcelona, Spain
Not Yet Recruiting
2
IDIBELL, Hospital Universitari de Bellvitge.
Barcelona, Barcelona, Spain, 08907
Actively Recruiting
3
Hospital del Mar
Barcelona, Barcelona, Spain
Not Yet Recruiting
4
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Not Yet Recruiting
5
Instituto Catalán de Oncología
L'Hospitalet de Llobregat, Barcelona, Spain
Active, Not Recruiting
6
Hospital Universitario Gregorio Marañón
Madrid, Madrid, Spain
Not Yet Recruiting
Research Team
I
Inés Ginot
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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