NCT04735198Recruiting
Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor 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.
Source: ClinicalTrials.gov · Last updated 20 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 21 Jan 2021
- Start date
- 20 Jan 2021
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Hospital Universitari de Bellvitge
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT04735198
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 20 Jan 2021 to the primary completion date, 1 Dec 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients that have gone through a previous bowel resection.
- Patients with previous cholecystectomy.
- Patients who are candidate to liver resection or liver transplant.
Other illness
- Pacients with biliary stone disease.
- 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.
Age
- Pacients with one gallbladder sessile polyp, presence of more than one polyp or patients older than 50 years old with a polyp.
Other
- Neuroendocrine tumors which are not located in jejunum or ileum (bronchial, gastric, pancreatic, descending colon, sigma or rectum.).
- Patients with a gallbladder polyp bigger than 6 mm.
- Refusal to participate.
- Medical criteria that doesn't consider the patient a candidate to participate in the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Not yet recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| IDIBELL, Hospital Universitari de Bellvitge. Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Instituto Catalán de Oncología Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.