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Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery.

NCT04735198 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-20

No results posted yet for this study

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.

Conditions

  • Midgut Carcinoid Tumor
  • Biliary Stones

Interventions

PROCEDURE

Primary tumor surgery

Large bowel resection.

PROCEDURE

Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomy

Large bowel resection combined and cholecystectomy.

Sponsors & Collaborators

  • Hospital Universitari de Bellvitge

    lead OTHER

Principal Investigators

  • Ricardo Frago Montanuy · Hospital Universitari de Bellvitge

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2025-12-01
Completion
2026-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04735198 on ClinicalTrials.gov