NCT03510923

Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy

Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy; the FANCY Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 17,380 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The FANCY study will investigate whether a selective policy of histopathological examination of appendices and gallbladders based on the intraoperative findings of the surgeon is safe and cost-effective.

Detailed description

Traditionally, all surgically removed appendices and gallbladders are sent to the department of pathology for histopathological examination. This is most likely not necessary in appendices and gallbladders that are not suspicious for a tumour when inspected visually or by palpation. If not detected by visual inspection or palpation, the tumour is usually of early stage and already treated with the resection of the organ. A policy of selective histopathological examination based on the intraoperative findings of the surgeon can probably reduce the amount of appendices and gallbladders that have to be examined by the pathologist, without a risk of undertreatment, with less risk of overtreatment and huge savings annually. In the FANCY study, a nationwide prospective multicenter observational cohort study, all appendices and gallbladders will be evaluated for tumours by visual inspection and palpation by the operating surgeon. The operating surgeon will report his or her findings and also write down whether he or she thinks there is an indication for histopathological examination. Subsequently, all specimens are sent to the pathologist for histopathological examination. Therefore, no aberrant findings will be missed due to this study. The prospective cohort can be compared through modelling to a hypothetical situation where appendices and gallbladders are only examined by the pathologist on indication. The primary outcome is the number of patients per 1000 examined appendices/gallbladders with a neoplasm requiring additional therapy benefitting the patient that would have been unnoticed in the policy of selective histopathological examination.

Conditions

• Appendix
• Appendectomy
• Appendiceal Neoplasms
• Gallbladder
• Cholecystectomy
• Gallbladder Neoplasms

Interventions

Type	Name	Description
OTHER	Inspection and palpation of the appendix	The removed appendix will be evaluated for tumours by the operating surgeon by visual inspection and digital palpation of the specimen. The appendix will not be opened. The surgeon will report his or her findings on a predefined scoring form: he or she will report all abnormalities and writes down whether he or she considers there is an indication for histopathological examination. Subsequently, all specimens will be sent for histopathological examination. Histopathological examination will be conducted according to the local protocol. In case of a neoplasm of the appendix, the treatment strategy is discussed and decided by the local multidisciplinary team. If an additional more extensive resection is decided to be appropriate, the specimens of the re-resection will be evaluated for the presence of remaining tumour tissue.
OTHER	Inspection and palpation of the gallbladder	The removed gallbladder will be evaluated for tumours by the operating surgeon by visual inspection and digital palpation of the specimen. The gallbladder is opened in its length, without cutting the cystic duct, and is inspected and palpated. The surgeon will report his or her findings on a predefined scoring form: he or she will report all abnormalities and writes down whether he or she considers there is an indication for histopathological examination. Subsequently, all specimens will be sent for histopathological examination. Histopathological examination will be conducted according to the local protocol. In case of a neoplasm of the gallbladder, the treatment strategy is discussed and decided by the local multidisciplinary team. If an additional more extensive resection is decided to be appropriate, the specimens of the re-resection will be evaluated for the presence of remaining tumour tissue.

Timeline

• Start date: 2018-05-01
• Primary completion: 2020-02-01
• Completion: 2020-12-24
• First posted: 2018-04-27
• Last updated: 2024-06-04

Locations

1 site across 1 country: Netherlands