Tests whether removing the gallbladder during bowel tumor surgery prevents gallstones
Compares gallbladder removal with bowel surgery alone in adults with midgut neuroendocrine tumors.
Plain-language title generated from the registry record
Registry title: Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery.
Key facts
- Where
- Badalona, Barcelona, L'Hospitalet de Llobregat, and Madrid, SpainSee the 6 sites
Where in Spain
- Hospital Universitari Trias i PujolBadalona, SpainNot yet recruiting
- Hospital del MarBarcelona, SpainNot yet recruiting
- Hospital Universitari Vall d'HebronBarcelona, SpainNot yet recruiting
- IDIBELL, Hospital Universitari de Bellvitge.Barcelona, SpainTaking people
- Instituto Catalán de OncologíaL'Hospitalet de Llobregat, SpainNo longer taking part
- Hospital Universitario Gregorio MarañónMadrid, SpainNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Universitari de Bellvitge
- Trial code
- NCT04735198
- Record updated
- 20 May 2025
- Original description
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.Read full original descriptionShow less
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.
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.
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: Patients that have gone through a previous bowel resection; Patients with previous cholecystectomy; Patients who are candidate to liver resection or liver transplant; 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; Pacients with one gallbladder sessile polyp, presence of more than one polyp or patients older than 50 years old with a polyp; 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.