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To evaluate two competitive strategies in patients undergoing resection of Small-intestine Neuroendocrine neoplasms (Si-NEN): Prophylactic Cholecystectomy (PC) versus On-demand delayed cholecystectomy
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic cholecystectomy | Patient who undergo resection of primary ileal neuroendocrine tumor and contemporarly 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecystectomy | Procedure | Laparoscopic or laparotomic cholecystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| mean number of re-hospitalization any cause |
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Inclusion Criteria:
Exclusion Criteria:
- presence of a history of a biliary stone disease or cholecystectomy before Si-NEN diagnosis
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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
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| Name | Affiliation | Role |
|---|---|---|
| Carlo Ingaldi, MD | Azienda Ospedaliero Universitaria, Ospedale S.Orsola Malpighi | Principal Investigator |
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the mean number of re-hospitalization for any cause after primary tumor surgery
| through study completion, an average of 7 years |
| 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 |
| total costs | total costs for primary tumor surgery plus any re-hospitalization | through study completion, an average of 7 years |
| COmplication rate | COmplication rate after primary tumor resection | through study completion, an average of 7 years |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D004067 | Digestive System Neoplasms |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| ID | Term |
|---|---|
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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