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.

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Universitari Trias i Pujol
NOT_YET_RECRUITING
Badalona
Hospital del Mar
NOT_YET_RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
NOT_YET_RECRUITING
Barcelona
IDIBELL, Hospital Universitari de Bellvitge.
RECRUITING
Barcelona
Instituto Catalán de Oncología
ACTIVE_NOT_RECRUITING
L'hospitalet De Llobregat
Hospital Universitario Gregorio Marañón
NOT_YET_RECRUITING
Madrid
Contact Information
Primary
Inés Ginot
inesginot@gmail.com
696014147
Time Frame
Start Date: 2021-01-20
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 100
Treatments
Active_comparator: Experimental group
Patients with midgut neuroendocrine tumor who will undergo only primary tumor surgery.
Experimental: Control group
Patients with midgut neuroendocrine tumor that will undergo through primary tumor surgery combined with prophylactic cholecystectomy.
Sponsors
Leads: Hospital Universitari de Bellvitge

This content was sourced from clinicaltrials.gov