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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Completed

Conditions: Gut Tumor; Surgery; Neuroendocrine Tumors

Treatments: Procedure: Cholecystectomy

Study type: Observational

Funder types: Other

Identifiers

NCT04780737

RAC 164/2017/ O/Oss

Details and patient eligibility

About

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

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

230 participants in 2 patient groups

Prophylactic cholecystectomy

Description:

Patient who undergo resection of primary ileal neuroendocrine tumor and contemporarly cholecystectomy

Treatment:

Procedure: Cholecystectomy

On-demand cholecystectomy

Description:

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

Treatment:

Procedure: Cholecystectomy