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

NCT04780737 | Completed

• 1 other identifier: RAC 164/2017/ O/Oss
• Study Type: observational
• Target: 230
• Locations: 0 countries
• Sites: N/A

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

Conditions

Neuroendocrine Tumors; Surgery; Gut Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• re-hospitalization rate for biliary stone disease

  through study completion, an average of 7 years

• mean number of re-hospitalization any cause

  through study completion, an average of 7 years

• mean number of re-hospitalization biliary stone disease

  through study completion, an average of 7 years

• total costs

  through study completion, an average of 7 years

• COmplication rate

  through study completion, an average of 7 years

Study Arms (2)

Prophylactic cholecystectomy

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

Procedure: 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

Interventions

Cholecystectomy PROCEDURE

Laparoscopic or laparotomic cholecystectomy

On-demand cholecystectomy; Prophylactic cholecystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• \- presence of a history of a biliary stone disease or cholecystectomy before Si-NEN diagnosis

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

MeSH Terms

Conditions

Neuroendocrine Tumors; Digestive System Neoplasms

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Site; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Carlo Ingaldi, MD

  Azienda Ospedaliero Universitaria, Ospedale S.Orsola Malpighi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: March 3, 2021
• Study Start: January 1, 2000
• Primary Completion: December 1, 2019
• Study Completion: July 1, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR