Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy

Completed

• Conditions: Appendix; Appendiceal Neoplasms; Gallbladder; Gallbladder Neoplasms; Cholecystectomy; Appendectomy
• Interventions: Other: Inspection and palpation of the appendix; Other: Inspection and palpation of the gallbladder

• Registration Number: NCT03510923
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Timeline

• Study First Submitted: 2018-04-18
• Study First Submitted QC: 2018-04-18
• Study First Posted: 2018-04-27
• Study Start: 2018-05-01
• Primary Completion: 2020-02-01
• Study Completion: 2020-12-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-01
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17380

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Costs	3 months	Costs of the policy with selective and with routine histopathological examination of the appendix/gallbladder.
Unnoticed neoplasms requiring additional therapy benefitting the patient	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Benefit of additional resection	2 weeks	Remaining tumour tissue and/or positive lymph nodes in re-resection specimen
Harm of additional resection	1 month	Incidence of postoperative complications
Other aberrant findings requiring additional therapy	3 months	Incidence of other aberrant findings as parasite infections, endometriosis, granulomatosis and benign neoplasms that require additional therapy.
Malignancies	2 weeks	Incidence of malignancies in resected appendices and gallbladders
Unnoticed malignancies	2 weeks	Incidence of unnoticed malignancies in resected appendices and gallbladders
Malignancies requiring more extensive resection or other additional treatment	3 months	Incidence of malignancies in resected appendices and gallbladders that subsequently require more extensive resection or other additional treatment.
Other aberrant findings	2 weeks	Incidence of other aberrant findings as parasite infections, endometriosis, granulomatosis and benign neoplasms.

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam-Zuidoost, Netherlands