Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery. (TNE-IDC-COLE)

May 15, 2025 updated by: Ricardo Frago Montanuy, Hospital Universitari de Bellvitge

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Title: 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.

Background: The prevalence of midgut NET has increased due to advances in diagnostic tests and its indolent course. When patients are diagnosed, they might be tributary to surgical treatment requiring an extensive bowel resection, and medical treatment with somatostatin analogs. Both treatments are related with gallbladder stone formation. The ENETS and NANETs recommend prophylactic cholecystectomy in patients with midgut NET who require primary tumor surgery, However, there is a lack of scientific evidence reinforcing this recommendation.

Objectives: The main objective is to evaluate the cumulated incidence rate of biliary stone disease in patients with midgut NET who require primary tumor resection, two years after the surgery.

Design: It's a multicentric, open-label and randomized clinical trial. Patients will be recruited from the General Surgery Services of the six Hospitals participating in the study. Patients must fullfill inclusion and exclusion criteria.

It is expected to recruit a maximum of one hundred patients in two years (50 per group). Patients will be randomly assigned into the Experimental group (primary tumor resections) or Control group (primary tumor resections combined with cholecystectomy). The investigators will follow up patients until week 104 after surgery (8 visits).

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital del Mar
        • Contact:
        • Principal Investigator:
          • Joan Altet
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
      • Barcelona, Spain, 08907
        • Recruiting
        • IDIBELL, Hospital Universitari de Bellvitge.
        • Contact:
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Gregorio Maranon
        • Contact:
    • Barcelona
      • Badalona, Barcelona, Spain
        • Not yet recruiting
        • Hospital Universitari Trias i Pujol
        • Contact:
      • L'Hospitalet De Llobregat, Barcelona, Spain
        • Active, not recruiting
        • Instituto Catalán de Oncología

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • Neuroendocrine tumors which are not located in jejunum or ileum (bronchial, gastric, pancreatic, descending colon, sigma or rectum.).
  • Patients that have gone through a previous bowel resection.
  • Patients with previous cholecystectomy.
  • Pacients with biliary stone disease.
  • Patients who are candidate to liver resection or liver transplant.
  • Patients with a gallbladder polyp bigger than 6 mm.
  • Pacients with one gallbladder sessile polyp, presence of more than one polyp or patients older than 50 years old with a polyp.
  • Refusal to participate.
  • 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.
  • Medical criteria that doesn't consider the patient a candidate to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Experimental group
Patients with midgut neuroendocrine tumor who will undergo only primary tumor surgery.
Procedure: Primary tumor surgery
Large bowel resection.
Other Names:
  • Bowel resection
Experimental: Control group
Patients with midgut neuroendocrine tumor that will undergo through primary tumor surgery combined with prophylactic cholecystectomy.
Procedure: Primary tumor surgery
Large bowel resection.
Other Names:
  • Bowel resection
Procedure: Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomy
Large bowel resection combined and cholecystectomy.
Other Names:
  • prophylactic cholecystectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the rate of biliary stone disease associated to patients with midgut NET that have gone through primary tumor surgery.
Time Frame: Two years after the surgery
Incidence of biliary stone disease in patients with midgut NET who requiere primary tumor surgery
Two years after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the incidence of post-operative complications until day 28 +/- 3 (1 Month) after the surgery.
Time Frame: One month after the surgery
Postoperative complications according Clavien-Dindo classification
One month after the surgery
To assess the incidence of: anastomotic dehiscence, wound infection, reoperation.
Time Frame: One month after the surgery
Specific complications
One month after the surgery
To evaluate the incidence of gallstone in patients who require a bowel resection and/or ileocecal junction resection.
Time Frame: Two years after the surgery
choledochal lithiasis or cholelithiasis
Two years after the surgery
To evaluate de incidence of gallstones in patients who will receive medical treatment with SSA
Time Frame: Two years after the surgery
choledochal lithiasis or cholelithiasis according medical treatment
Two years after the surgery
To describe bowel movements of patients after the surgery.
Time Frame: Two years after the surgery
Gastrointestinal Quality of Life Index (GIQLY);Minimum value of 0 (the worst health state) and a maximum of 100 (best health state)
Two years after the surgery
To compare quality of life in patients who went through a prophylactic cholecystectomy against those who did not.
Time Frame: Two years after the surgery
Health related Quality of life 15 D (HRQoL 15D);There are 15 areas with a minimum value of 0 (the worst health state) and a maximum of 100 (best health state) 15D
Two years after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Investigators

  • Principal Investigator: Ricardo Frago Montanuy, Hospital Universitari de Bellvitge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

January 21, 2021

First Submitted That Met QC Criteria

January 30, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Estimated)

May 20, 2025

Last Update Submitted That Met QC Criteria

May 15, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR348/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

That's not decided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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