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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04780737
Enrollment
230
Registered
2021-03-03
Start date
2000-01-31
Completion date
2020-07-31
Last updated
2021-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Tumor, Neuroendocrine Tumors, Surgery

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.

Interventions

PROCEDURECholecystectomy

Laparoscopic or laparotomic cholecystectomy

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
re-hospitalization rate for any causethrough study completion, an average of 7 yearsthe re-hospitalization rate for any cause after primary tumor surgery

Secondary

MeasureTime frameDescription
re-hospitalization rate for biliary stone diseasethrough study completion, an average of 7 yearsthe re-hospitalization rate for biliary stone disease after primary tumor surgery
mean number of re-hospitalization any causethrough study completion, an average of 7 yearsthe mean number of re-hospitalization for any cause after primary tumor surgery
mean number of re-hospitalization biliary stone diseasethrough study completion, an average of 7 yearsthe mean number of re-hospitalization for biliary stone disease after primary tumor surgery
total coststhrough study completion, an average of 7 yearstotal costs for primary tumor surgery plus any re-hospitalization
COmplication ratethrough study completion, an average of 7 yearsCOmplication rate after primary tumor resection

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026