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

Completed

• Conditions: Surgery; Neuroendocrine Tumors; Gut Tumor
• Interventions: Procedure: Cholecystectomy

• Registration Number: NCT04780737
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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

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.

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2019-12
• Study Completion: 2020-07
• Study First Submitted: 2021-01-08
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-02
• Last Update Submitted: 2021-03-02
• Study First Posted: 2021-03-03
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
On-demand cholecystectomy	Cholecystectomy	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
Prophylactic cholecystectomy	Cholecystectomy	Patient who undergo resection of primary ileal neuroendocrine tumor and contemporarly cholecystectomy

Primary Outcome Measures

Name	Time	Method
re-hospitalization rate for any cause	through study completion, an average of 7 years	the re-hospitalization rate for any cause after primary tumor surgery

Secondary Outcome Measures

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