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Completed

NCT Number: NCT03510923

Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy

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.

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Key information

Conditions

Appendix Appendectomy Appendiceal Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Cecal Diseases Cecal Neoplasms Cholecystectomy Digestive System Diseases Digestive System Neoplasms Gallbladder Gallbladder Diseases Gallbladder Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Primary location

Academic Medical Center

Amsterdam-Zuidoost, 1105 AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inspection and palpation of the appendix

Other

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

Other

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.

Primary outcomes

  1. Unnoticed neoplasms requiring additional therapy benefitting the patient

    Time frame: 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.

  2. Costs

    Time frame: 3 months

    Costs of the policy with selective and with routine histopathological examination of the appendix/gallbladder.

Secondary outcomes

  1. Malignancies

    Time frame: 2 weeks

    Incidence of malignancies in resected appendices and gallbladders

  2. Unnoticed malignancies

    Time frame: 2 weeks

    Incidence of unnoticed malignancies in resected appendices and gallbladders

  3. Malignancies requiring more extensive resection or other additional treatment

    Time frame: 3 months

    Incidence of malignancies in resected appendices and gallbladders that subsequently require more extensive resection or other additional treatment.

  4. Benefit of additional resection

    Time frame: 2 weeks

    Remaining tumour tissue and/or positive lymph nodes in re-resection specimen

  5. Harm of additional resection

    Time frame: 1 month

    Incidence of postoperative complications

  6. Other aberrant findings

    Time frame: 2 weeks

    Incidence of other aberrant findings as parasite infections, endometriosis, granulomatosis and benign neoplasms.

  7. Other aberrant findings requiring additional therapy

    Time frame: 3 months

    Incidence of other aberrant findings as parasite infections, endometriosis, granulomatosis and benign neoplasms that require additional therapy.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: FANCY

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 27, 2018
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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