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

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

Study Overview

• Status: Completed
• Conditions: Surgery; Neuroendocrine Tumors; Gut Tumor
• Intervention / Treatment: Procedure: 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 Type: Observational
• Enrollment (Actual): 230

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

For each patient sex, age, comorbidity, presence of symptoms, type of surgery (emergency or elective), ENETS TNM stage, WHO 2019 grading of the primary tumor, type of resection (R0/1 vs. R2), administration of SSA therapy, duration of follow-up, were collected

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prophylactic cholecystectomy; Patient who undergo resection of primary ileal neuroendocrine tumor and contemporarly cholecystectomy	Procedure: Cholecystectomy; 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	Procedure: Cholecystectomy; Laparoscopic or laparotomic cholecystectomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Carlo Ingaldi, MD, Azienda Ospedaliero Universitaria, Ospedale S.Orsola Malpighi

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2000
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplasms; Neuroendocrine Tumors
• Other Study ID Numbers: RAC 164/2017/ O/Oss

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No