- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03510923
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
-
-
-
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.
|
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.
|
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.
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.
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
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Gallbladder Diseases
- Biliary Tract Diseases
- Cecal Diseases
- Biliary Tract Neoplasms
- Cecal Neoplasms
- Neoplasms
- Gallbladder Neoplasms
- Appendiceal Neoplasms
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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