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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

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ClinicalTrials.gov Identifier: NCT04780737
Recruitment Status : Completed
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Carlo Ingaldi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

Condition or disease Intervention/treatment
Neuroendocrine Tumors Surgery Gut Tumor 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 5 Years
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
Actual Study Start Date : January 2000
Actual Primary Completion Date : December 2019
Actual Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780737


Sponsors and Collaborators
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Investigators
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Principal Investigator: Carlo Ingaldi, MD Azienda Ospedaliero Universitaria, Ospedale S.Orsola Malpighi
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Responsible Party: Carlo Ingaldi, MD, Principal Investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
ClinicalTrials.gov Identifier: NCT04780737    
Other Study ID Numbers: RAC 164/2017/ O/Oss
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue