Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy (FANCY)

August 31, 2020 updated by: Prof. dr. W.A. Bemelman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

11156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam-Zuidoost, Netherlands, 1105 AZ
        • Academic Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who are scheduled to undergo an appendectomy or cholecystectomy in one of the participating centers in The Netherlands.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
Costs
Time Frame: 3 months
Costs of the policy with selective and with routine histopathological examination of the appendix/gallbladder.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Malignancies
Time Frame: 2 weeks
Incidence of malignancies in resected appendices and gallbladders
2 weeks
Unnoticed malignancies
Time Frame: 2 weeks
Incidence of unnoticed malignancies in resected appendices and gallbladders
2 weeks
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.
3 months
Benefit of additional resection
Time Frame: 2 weeks
Remaining tumour tissue and/or positive lymph nodes in re-resection specimen
2 weeks
Harm of additional resection
Time Frame: 1 month
Incidence of postoperative complications
1 month
Other aberrant findings
Time Frame: 2 weeks
Incidence of other aberrant findings as parasite infections, endometriosis, granulomatosis and benign neoplasms.
2 weeks
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Willem Bemelman, Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

February 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

April 18, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (Actual)

April 27, 2018

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W17_328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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