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

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ClinicalTrials.gov Identifier: NCT03510923
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Prof. dr. W.A. Bemelman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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
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.

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Study Type : Observational
Estimated Enrollment : 8924 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Selective Rather Than Routine Histopathological Examination After Appendectomy and Cholecystectomy; the FANCY Study
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03510923


Contacts
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Contact: Vivian Bastiaenen, MD +31205665199 V.P.Bastiaenen@amc.nl
Contact: Willem Bemelman, Professor W.A.Bemelman@amc.nl

Locations
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Netherlands
Academic Medical Center Recruiting
Amsterdam-Zuidoost, Netherlands, 1105 AZ
Contact: Vivian Bastiaenen, MD    +31205665199    v.p.bastiaenen@amc.nl   
Contact: Willem Bemelman         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: Willem Bemelman, Professor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Responsible Party: Prof. dr. W.A. Bemelman, Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03510923     History of Changes
Other Study ID Numbers: W17_328
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. dr. W.A. Bemelman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Appendix
Appendectomy
Gallbladder
Cholecystectomy
Neoplasms
Pathology
Selective
Routine
Additional relevant MeSH terms:
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Gallbladder Neoplasms
Appendiceal Neoplasms
Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Cecal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Cecal Diseases
Intestinal Diseases