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OpenTrials
Completed

NCT Number: NCT04780737

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

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Key information

Conditions

Neuroendocrine Tumors Digestive System Diseases Digestive System Neoplasms Gut Tumor Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecystectomy

Procedure

Laparoscopic or laparotomic cholecystectomy

Primary outcomes

  1. re-hospitalization rate for any cause

    Time frame: through study completion, an average of 7 years

    the re-hospitalization rate for any cause after primary tumor surgery

Secondary outcomes

  1. re-hospitalization rate for biliary stone disease

    Time frame: through study completion, an average of 7 years

    the re-hospitalization rate for biliary stone disease after primary tumor surgery

  2. mean number of re-hospitalization any cause

    Time frame: through study completion, an average of 7 years

    the mean number of re-hospitalization for any cause after primary tumor surgery

  3. mean number of re-hospitalization biliary stone disease

    Time frame: through study completion, an average of 7 years

    the mean number of re-hospitalization for biliary stone disease after primary tumor surgery

  4. total costs

    Time frame: through study completion, an average of 7 years

    total costs for primary tumor surgery plus any re-hospitalization

  5. COmplication rate

    Time frame: through study completion, an average of 7 years

    COmplication rate after primary tumor resection

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2000
Primary completion
2019
Study completion
2020
First posted
Mar 3, 2021
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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