Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy

Cholecystectomy Clinical Trial

— FANCY  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03510923
• Other study ID #: W17_328
• Status: Active, not recruiting
• Start date: May 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: August 2020
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• 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: Active, not recruiting
• Enrollment: 11156
• Est. completion date: September 1, 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.

Related Conditions & MeSH terms

• Appendectomy
• Appendiceal Neoplasms
• Appendix
• Cholecystectomy
• Gallbladder
• Gallbladder Neoplasms
• Neoplasms

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