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

NCT04735198 | Recruiting

• 1 other identifier: PR348/20
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Neuroendocrine tumor; prophylactic cholecystectomy; Biliary stone disease

Outcome Measures

Primary Outcomes (1)

• To evaluate the rate of biliary stone disease associated to patients with midgut NET that have gone through primary tumor surgery.

  Incidence of biliary stone disease in patients with midgut NET who requiere primary tumor surgery

  Two years after the surgery

Secondary Outcomes (6)

• To assess the incidence of post-operative complications until day 28 +/- 3 (1 Month) after the surgery.

  One month after the surgery

• To assess the incidence of: anastomotic dehiscence, wound infection, reoperation.

  One month after the surgery

• To evaluate the incidence of gallstone in patients who require a bowel resection and/or ileocecal junction resection.

  Two years after the surgery

• To evaluate de incidence of gallstones in patients who will receive medical treatment with SSA

  Two years after the surgery

• To describe bowel movements of patients after the surgery.

  Two years after the surgery

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

Patients with midgut neuroendocrine tumor who will undergo only primary tumor surgery.

Procedure: Primary tumor surgery

Control group

EXPERIMENTAL

Patients with midgut neuroendocrine tumor that will undergo through primary tumor surgery combined with prophylactic cholecystectomy.

Procedure: Primary tumor surgery; Procedure: Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomy

Interventions

Primary tumor surgery PROCEDURE

Large bowel resection.

Also known as: Bowel resection

Control group; Experimental group

Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomy PROCEDURE

Large bowel resection combined and cholecystectomy.

Also known as: prophylactic cholecystectomy.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (6)

Hospital Universitari Trias i Pujol

Badalona, Barcelona, Spain

NOT YET RECRUITING

IDIBELL, Hospital Universitari de Bellvitge.

Barcelona, Barcelona, 08907, Spain

RECRUITING

Hospital del Mar

Barcelona, Barcelona, Spain

NOT YET RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, Spain

NOT YET RECRUITING

Instituto Catalán de Oncología

L'Hospitalet de Llobregat, Barcelona, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Gregorio Marañón

Madrid, Madrid, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Cholecystolithiasis; Neuroendocrine Tumors

Interventions

Colectomy

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ricardo Frago Montanuy

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inés Ginot

CONTACT

696014147; inesginot@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 3, 2021
• Study Start: January 20, 2021
• Primary Completion: December 1, 2025
• Study Completion: February 28, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)