Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy (FANCY)

A

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Completed

Conditions

Appendix
Cholecystectomy
Gallbladder
Appendiceal Neoplasms
Gallbladder Neoplasms
Appendectomy

Treatments

Other: Inspection and palpation of the gallbladder
Other: Inspection and palpation of the appendix

Study type

Observational

Funder types

Other

Identifiers

NCT03510923
W17_328

Details and patient eligibility

About

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.

Full 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.

Enrollment

17,380 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients scheduled to undergo an appendectomy or cholecystectomy in the elective or non-elective setting.

Exclusion criteria

  • Primary indication for surgery: strong suspicion or proven malignancy in the appendix or gallbladder.
  • Appendix or gallbladder removed as part of more extensive surgery, so-called incidental appendectomies or cholecystectomies.
  • Patients included in the ACCURE trial (effect of appendectomy on ulcerative colitis).
  • The presence of a gallbladder polyp of >10 mm on preoperative imaging.

Trial design

17,380 participants in 2 patient groups

Patients who underwent an appendectomy
Description:
Patients of all ages who underwent an appendectomy in the elective or non-elective setting.
Treatment:
Other: Inspection and palpation of the appendix
Patients who underwent a cholecystectomy
Description:
Patients of all ages who underwent a cholecystectomy in the elective or non-elective setting.
Treatment:
Other: Inspection and palpation of the gallbladder

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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