RecruitingNot ApplicableNCT04735198

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.


Sponsor

Hospital Universitari de Bellvitge

Enrollment

100 participants

Start Date

Jan 20, 2021

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether removing the gallbladder at the same time as surgery for small intestine neuroendocrine tumors (a type of slow-growing cancer) helps prevent future gallbladder problems, particularly gallstones that often develop after treatment. **You may be eligible if...** - You are male or female, over 18 years old - You have been diagnosed with a neuroendocrine tumor of the midgut (small intestine area) that can be treated with surgery - You have provided written informed consent - If you are a woman of childbearing age, a negative pregnancy test is required **You may NOT be eligible if...** - Surgery is not being planned as part of your treatment - You have previously had your gallbladder removed - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREPrimary tumor surgery

Large bowel resection.

PROCEDUREPrimary tumor surgery (bowel resection) combined with prophylactic cholecystectomy

Large bowel resection combined and cholecystectomy.


Locations(6)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04735198


Related Trials