AppendixFANCYNCT03510923
Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy
An observational study of Appendix and Appendectomy, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Appendix, Appendectomy, Appendiceal Neoplasms
- What is being tested?
- Inspection and palpation of the appendix and Inspection and palpation of the gallbladder
- How many people
- 17,380 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2018to 24 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are scheduled to undergo an appendectomy or cholecystectomy in one of the participating centers in The Netherlands.
Who may be able to join
- Patients scheduled to undergo an appendectomy or cholecystectomy in the elective or non-elective setting.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Appendix, Appendectomy, Appendiceal Neoplasms, Gallbladder, Cholecystectomy, Gallbladder Neoplasms
- Being tested
- Inspection and palpation of the appendix, Inspection and palpation of the gallbladder
- Keywords
- Appendix, Appendectomy, Gallbladder, Cholecystectomy, Neoplasms, Pathology, Selective, Routine
- Medical subject headings
- Appendiceal Neoplasms, Gallbladder Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspection and palpation of the appendixOther
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 gallbladderOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent an appendectomy | Patients of all ages who underwent an appendectomy in the elective or non-elective setting. Receives: Other: Inspection and palpation of the appendix | |
| Patients who underwent a cholecystectomy | Patients of all ages who underwent a cholecystectomy in the elective or non-elective setting. Receives: Other: Inspection and palpation of the gallbladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Costs
Costs of the policy with selective and with routine histopathological examination of the appendix/gallbladder.
Measured: 3 months
Secondary outcomes (7)
Malignancies
Incidence of malignancies in resected appendices and gallbladders
Measured: 2 weeks
Unnoticed malignancies
Incidence of unnoticed malignancies in resected appendices and gallbladders
Measured: 2 weeks
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.
Measured: 3 months
Benefit of additional resection
Remaining tumour tissue and/or positive lymph nodes in re-resection specimen
Measured: 2 weeks
Harm of additional resection
Incidence of postoperative complications
Measured: 1 month
Other aberrant findings
Incidence of other aberrant findings as parasite infections, endometriosis, granulomatosis and benign neoplasms.
Measured: 2 weeks
Other aberrant findings requiring additional therapy
Incidence of other aberrant findings as parasite infections, endometriosis, granulomatosis and benign neoplasms that require additional therapy.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 May 2018
- Primary completion1 Feb 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppendixStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17,380 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Willem A. Bemelman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Willem Bemelman, Professor, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510923
- Sponsor's protocol ID
- W17_328
- Acronym
- FANCY
- Status last verified
- Jun 2024
- First submitted
- 18 Apr 2018
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bastiaenen VP, Corten BJ, de Savornin Lohman EA, de Jonge J, Kraima AC, Swank HA, van Vliet JL, van Acker GJ, van Geloven AA, In 't Hof KH, Koens L, de Reuver PR, van Rossem CC, Slooter GD, Tanis PJ, Terpstra V, Dijkgraaf MG, Bemelman WA. Safety and cost analysis of selective histopathological examination following appendicectomy and cholecystectomy (FANCY study): protocol and statistical analysis plan of a prospective observational multicentre study. BMJ Open. 2019 Dec 23;9(12):e035912. doi: 10.1136/bmjopen-2019-035912.
PubMed 31874901
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Rather Than Routine Histopathological Examination Following Appendectomy and Cholecystectomy; the FANCY Study.
- ClinicalTrials.gov ID
- NCT03510923
- Acronym / sponsor ID
- FANCY / W17_328
- Conditions
- Appendix, Appendectomy, Appendiceal Neoplasms, Gallbladder, Cholecystectomy, Gallbladder Neoplasms
- Keywords
- Appendix, Appendectomy, Gallbladder, Cholecystectomy, Neoplasms, Pathology, Selective, Routine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,380 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 27 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent an appendectomy | – | Other: Inspection and palpation of the appendixPatients of all ages who underwent an appendectomy in the elective or non-elective setting. |
| Patients who underwent a cholecystectomy | – | Other: Inspection and palpation of the gallbladderPatients of all ages who underwent a cholecystectomy in the elective or non-elective setting. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are scheduled to undergo an appendectomy or cholecystectomy in one of the participating centers in The Netherlands.
Key inclusion criteria (1 listed)
- Patients scheduled to undergo an appendectomy or cholecystectomy in the elective or non-elective setting.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspection and palpation of the appendixThe 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. | Other | Patients who underwent an appendectomy |
| Inspection and palpation of the gallbladderThe 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. | Other | Patients who underwent a cholecystectomy |
Primary outcome
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.
Costs
Time frame: 3 months
Costs of the policy with selective and with routine histopathological examination of the appendix/gallbladder.
7 secondary outcomes
Malignancies
Time frame: 2 weeks
Unnoticed malignancies
Time frame: 2 weeks
Malignancies requiring more extensive resection or other additional treatment
Time frame: 3 months
Benefit of additional resection
Time frame: 2 weeks
Harm of additional resection
Time frame: 1 month
Other aberrant findings
Time frame: 2 weeks
Other aberrant findings requiring additional therapy
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 31874901Bastiaenen VP, Corten BJ, de Savornin Lohman EA, de Jonge J, Kraima AC, Swank HA, van Vliet JL, van Acker GJ, van Geloven AA, In 't Hof KH, Koens L, de Reuver PR, van Rossem CC, Slooter GD, Tanis PJ, Terpstra V, Dijkgraaf MG, Bemelman WA. Safety and cost analysis of selective histopathological examination following appendicectomy and cholecystectomy (FANCY study): protocol and statistical analysis plan of a prospective observational multicentre study. BMJ Open. 2019 Dec 23;9(12):e035912. doi: 10.1136/bmjopen-2019-035912.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willem Bemelman, Professor principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendix and Appendectomy, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unnoticed neoplasms requiring additional therapy benefitting the patient (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03510923, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.