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

NCT ID: NCT04780737

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2000-01-31
• Study Completion Date: 2020-07-31

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.

Conditions

Neuroendocrine Tumors; Surgery; Gut Tumor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Prophylactic cholecystectomy

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

Cholecystectomy

Intervention Type: PROCEDURE

Laparoscopic or laparotomic cholecystectomy

On-demand 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

Cholecystectomy

Intervention Type: PROCEDURE

Laparoscopic or laparotomic cholecystectomy

Interventions

Cholecystectomy

Laparoscopic or laparotomic cholecystectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Carlo Ingaldi, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlo Ingaldi, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero Universitaria, Ospedale S.Orsola Malpighi

Other Identifiers

RAC 164/2017/ O/Oss

Identifier Type: -

Identifier Source: org_study_id