Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery.
NCT ID: NCT04735198
Last Updated: 2025-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2021-01-20
2026-02-28
Brief Summary
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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.
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Detailed Description
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Background: The prevalence of midgut NET has increased due to advances in diagnostic tests and its indolent course. When patients are diagnosed, they might be tributary to surgical treatment requiring an extensive bowel resection, and medical treatment with somatostatin analogs. Both treatments are related with gallbladder stone formation. The ENETS and NANETs recommend prophylactic cholecystectomy in patients with midgut NET who require primary tumor surgery, However, there is a lack of scientific evidence reinforcing this recommendation.
Objectives: The main objective is to evaluate the cumulated incidence rate of biliary stone disease in patients with midgut NET who require primary tumor resection, two years after the surgery.
Design: It's a multicentric, open-label and randomized clinical trial. Patients will be recruited from the General Surgery Services of the six Hospitals participating in the study. Patients must fullfill inclusion and exclusion criteria.
It is expected to recruit a maximum of one hundred patients in two years (50 per group). Patients will be randomly assigned into the Experimental group (primary tumor resections) or Control group (primary tumor resections combined with cholecystectomy). The investigators will follow up patients until week 104 after surgery (8 visits).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
Patients with midgut neuroendocrine tumor who will undergo only primary tumor surgery.
Primary tumor surgery
Large bowel resection.
Control group
Patients with midgut neuroendocrine tumor that will undergo through primary tumor surgery combined with prophylactic cholecystectomy.
Primary tumor surgery
Large bowel resection.
Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomy
Large bowel resection combined and cholecystectomy.
Interventions
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Primary tumor surgery
Large bowel resection.
Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomy
Large bowel resection combined and cholecystectomy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Ricardo Frago Montanuy
Principal Investigator
Principal Investigators
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Ricardo Frago Montanuy
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Bellvitge
Locations
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Hospital Universitari Trias i Pujol
Badalona, Barcelona, Spain
IDIBELL, Hospital Universitari de Bellvitge.
Barcelona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Instituto Catalán de Oncología
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Gregorio Marañón
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PR348/20
Identifier Type: -
Identifier Source: org_study_id
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