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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04780737
• Other study ID #: RAC 164/2017/ O/Oss
• Status: Completed
• Start date: January 2000
• Est. completion date: July 2020

Study information

• Verified date: March 2021
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: July 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gut Tumor
• Neoplasms
• Neuroendocrine Tumors
• Surgery

Intervention

Procedure:
• Cholecystectomy
Laparoscopic or laparotomic cholecystectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	total costs	total costs for primary tumor surgery plus any re-hospitalization	through study completion, an average of 7 years
Secondary	COmplication rate	COmplication rate after primary tumor resection	through study completion, an average of 7 years