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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03510923
Other study ID # W17_328
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2018
Est. completion date December 24, 2020

Study information

Verified date June 2024
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 17380
Est. completion date December 24, 2020
Est. primary completion date February 1, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Intervention

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.
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.

Locations

Country Name City State
Netherlands Academic Medical Center Amsterdam-Zuidoost

Sponsors (2)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Unnoticed neoplasms requiring additional therapy benefitting the patient 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. 3 months
Primary Costs Costs of the policy with selective and with routine histopathological examination of the appendix/gallbladder. 3 months
Secondary Malignancies Incidence of malignancies in resected appendices and gallbladders 2 weeks
Secondary Unnoticed malignancies Incidence of unnoticed malignancies in resected appendices and gallbladders 2 weeks
Secondary Malignancies requiring more extensive resection or other additional treatment Incidence of malignancies in resected appendices and gallbladders that subsequently require more extensive resection or other additional treatment. 3 months
Secondary Benefit of additional resection Remaining tumour tissue and/or positive lymph nodes in re-resection specimen 2 weeks
Secondary Harm of additional resection Incidence of postoperative complications 1 month
Secondary Other aberrant findings Incidence of other aberrant findings as parasite infections, endometriosis, granulomatosis and benign neoplasms. 2 weeks
Secondary Other aberrant findings requiring additional therapy Incidence of other aberrant findings as parasite infections, endometriosis, granulomatosis and benign neoplasms that require additional therapy. 3 months
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