An interventional study of Primary tumor surgery and Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomy in Midgut Carcinoid Tumor and Biliary Stones, sponsored by Hospital Universitari de Bellvitge. Recruiting at 6 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-20.
Sponsored by Hospital Universitari de Bellvitge · Not applicable, Interventional, and Treatment
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.
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).
88 studies on the registry are indexed under Cholecystolithiasis; 17 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 59 interventional studies indexed under Cholecystolithiasis.
Browse Cholecystolithiasis studies →Hospital Universitari de Bellvitge is the lead sponsor of 120 studies on the registry; 29 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with midgut neuroendocrine tumor who will undergo only primary tumor surgery.
Procedure: Primary tumor surgery
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
Large bowel resection.
Also known as: Bowel resection
Large bowel resection combined and cholecystectomy.
Also known as: prophylactic cholecystectomy.
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
Time frame: Two years after the surgery
To assess the incidence of post-operative complications until day 28 +/- 3 (1 Month) after the surgery.
Postoperative complications according Clavien-Dindo classification
Time frame: One month after the surgery
To assess the incidence of: anastomotic dehiscence, wound infection, reoperation.
Specific complications
Time frame: One month after the surgery
To evaluate the incidence of gallstone in patients who require a bowel resection and/or ileocecal junction resection.
choledochal lithiasis or cholelithiasis
Time frame: Two years after the surgery
To evaluate de incidence of gallstones in patients who will receive medical treatment with SSA
choledochal lithiasis or cholelithiasis according medical treatment
Time frame: Two years after the surgery
To describe bowel movements of patients 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)
Time frame: Two years after the surgery
To compare quality of life in patients who went through a prophylactic cholecystectomy against those who did not.
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
Time frame: Two years after the surgery
Not enrolling at this site.
Plan to share: No — That's not decided yet
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