Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitari de Bellvitge
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Primary tumor surgery
Procedure/SurgeryLarge bowel resection.
Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomy
Procedure/SurgeryLarge bowel resection combined and cholecystectomy.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Experimental groupActive comparator 1 intervention
Group B: Control groupExperimental treatment 2 interventions
Trial outcomes
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
Time frame
Two years after the surgerySecondary outcomes
1
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 surgery2
To assess the incidence of: anastomotic dehiscence, wound infection, reoperation.
Specific complications
Time frame
One month after the surgery3
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 surgery4
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 surgerySponsors and contacts
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Source ClinicalTrials.gov