FANCY: Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy

Sponsor

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

Overall Status

Unknown status

CT.gov ID

NCT03510923

Collaborator

ZonMw: The Netherlands Organisation for Health Research and Development (Other)

11,156

Enrollment

Location

28.1

Anticipated Duration (Months)

397.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Appendix Appendectomy Appendiceal Neoplasms Gallbladder Cholecystectomy Gallbladder Neoplasms	Other: Inspection and palpation of the appendix Other: Inspection and palpation of the gallbladder

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 Design

Study Type:

Observational

Anticipated Enrollment :

11156 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2018

Actual Primary Completion Date :

Feb 1, 2020

Anticipated Study Completion Date :

Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Patients who underwent an appendectomy Patients of all ages who underwent an appendectomy in the elective or non-elective setting.	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.
Patients who underwent a cholecystectomy Patients of all ages who underwent a cholecystectomy in the elective or non-elective setting.	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.

Arm

Intervention/Treatment

Patients who underwent an appendectomy

Patients of all ages who underwent an appendectomy in the elective or non-elective setting.

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.

Patients who underwent a cholecystectomy

Patients of all ages who underwent a cholecystectomy in the elective or non-elective setting.

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.

Outcome Measures

Primary Outcome Measures

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.
Costs [3 months]
Costs of the policy with selective and with routine histopathological examination of the appendix/gallbladder.

Secondary Outcome Measures

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.
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 [2 weeks]
Incidence of other aberrant findings as parasite infections, endometriosis, granulomatosis and benign neoplasms.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.