Clinical trial · Observational

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

NCT04780737CI-TRIAL-00050435completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Gut Tumor	Digestive System Neoplasm	PROBABILISTIC	0.70
Neuroendocrine Tumors	Neuroendocrine Tumor	ONTOLOGY_EXACT	0.90
Surgery	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Cholecystectomy	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
Prophylactic cholecystectomy
description
Patient who undergo resection of primary ileal neuroendocrine tumor and contemporarly cholecystectomy
interventionNames
1. Procedure: Cholecystectomy
label
On-demand cholecystectomy
description
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
interventionNames
1. Procedure: Cholecystectomy

Primary outcomes (1)

measure
re-hospitalization rate for any cause
timeFrame
through study completion, an average of 7 years
description
the re-hospitalization rate for any cause after primary tumor surgery

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.