Clinical trial NCT03510923: Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy
Official title: Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy; the FANCY Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendix
Appendectomy
Appendiceal Neoplasms
Gallbladder
Cholecystectomy
Gallbladder Neoplasms
Keywords: Appendix
Appendectomy
Gallbladder
Cholecystectomy
Neoplasms
Pathology
Selective
Routine
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2018-04-27
Enrollment: 17380
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are scheduled to undergo an appendectomy or cholecystectomy in one of the participating centers in The Netherlands.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Unnoticed neoplasms requiring additional therapy benefitting the patient
timeFrame: 3 months
measure: Costs
timeFrame: 3 months
Secondary outcomes:
measure: Malignancies
timeFrame: 2 weeks
measure: Unnoticed malignancies
timeFrame: 2 weeks
measure: Malignancies requiring more extensive resection or other additional treatment
timeFrame: 3 months
measure: Benefit of additional resection
timeFrame: 2 weeks
measure: Harm of additional resection
timeFrame: 1 month
measure: Other aberrant findings
timeFrame: 2 weeks
measure: Other aberrant findings requiring additional therapy
timeFrame: 3 months
Other outcomes:
Locations:
city: Amsterdam-Zuidoost
country: Netherlands
facility: Academic Medical Center
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Willem Bemelman, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bastiaenen VP, Corten BJ, de Savornin Lohman EA, de Jonge J, Kraima AC, Swank HA, van Vliet JL, van Acker GJ, van Geloven AA, In 't Hof KH, Koens L, de Reuver PR, van Rossem CC, Slooter GD, Tanis PJ, Terpstra V, Dijkgraaf MG, Bemelman WA. Safety and cost analysis of selective histopathological examination following appendicectomy and cholecystectomy (FANCY study): protocol and statistical analysis plan of a prospective observational multicentre study. BMJ Open. 2019 Dec 23;9(12):e035912. doi: 10.1136/bmjopen-2019-035912.