Prophylactic Cholecystectomy is Not Mandatory in Patients Candidate to the Resection for Small Intestine Neuroendocrine Neoplasms: a Propensity Score-matched and Cost-minimization Analysis

Study Overview
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Brief Summary
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To evaluate two competitive strategies in patients undergoing resection of Small-intestine Neuroendocrine neoplasms (Si-NEN): Prophylactic Cholecystectomy (PC) versus On-demand delayed cholecystectomy

Detailed Description
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This is a retrospective study based on 230 Si-NENs candidates to the primary tumor resection. Patients were divided into two arms: PC and OC. Propensity score matching was performed, reporting the d value. The primary outcome was the re-hospitalization rate for any cause. The secondary endpoints were the re-hospitalization rate for biliary stone disease (BSD), the mean number of re-hospitalization (any cause and BSD), the complication rate (all and severe), and the total costs. A P-value < 0.05 was considered significant, and NNT< 10 was considered clinically relevant.

Official Title
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Prophylactic Cholecystectomy is Not Mandatory in Patients Candidate to the Resection for Small Intestine Neuroendocrine Neoplasms: a Propensity Score-matched and Cost-minimization Analysis

Conditions
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Neuroendocrine Tumors, Surgery, Gut Tumor

Intervention / Treatment
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* Procedure: Cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with a diagnosis of Si-NEN; resection of the primary tumor with or without concomitant cholecystectomy; absence of a history of a biliary stone disease or cholecystectomy before Si-NEN diagnosis Exclusion Criteria: - presence of a history of a biliary stone disease or cholecystectomy before Si-NEN diagnosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prophylactic cholecystectomy<br>Patient who undergo resection of primary ileal neuroendocrine tumor and contemporarly cholecystectomy | Procedure: Cholecystectomy<br>* Laparoscopic or laparotomic cholecystectomy<br>|
| On-demand cholecystectomy<br>Patient resected for primary ileal neuroendocrine tumor, treated with cholecystectomy in a different operation and only if needed, for the development of biliary stone disease | Procedure: Cholecystectomy<br>* Laparoscopic or laparotomic cholecystectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| re-hospitalization rate for any cause | the re-hospitalization rate for any cause after primary tumor surgery | through study completion, an average of 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| re-hospitalization rate for biliary stone disease | the re-hospitalization rate for biliary stone disease after primary tumor surgery | through study completion, an average of 7 years | 
| mean number of re-hospitalization any cause | the mean number of re-hospitalization for any cause after primary tumor surgery | through study completion, an average of 7 years | 
| mean number of re-hospitalization biliary stone disease | the mean number of re-hospitalization for biliary stone disease after primary tumor surgery | through study completion, an average of 7 years | 
| total costs | total costs for primary tumor surgery plus any re-hospitalization | through study completion, an average of 7 years | 
| COmplication rate | COmplication rate after primary tumor resection | through study completion, an average of 7 years |