PathologyNCT04352478
Incidental Cancer in Gallbladder Surgical Specimens Focus on Elderly Patients
An observational study of Pathology, run by Dr. Ersin Arslan Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Causes such as long-term stones and polyp are thought to play a role in the etiology of gallbladder cancer. The routine histopathological examination provides the detection of incidental gallbladder cancers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pathology
- What is being tested?
- Histopathological result
- How many people
- 2,389 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2020to 13 Apr 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 underwent cholecystectomy between January 2016 and February 2020 at our hospital
Who may be able to join
- acute cholecystectomy
- elective cholecystectomy
Who cannot join
- lack of data
- incidental cholecystectomy,
- cholecystectomy secondary to trauma
- cholecystectomy secondary to malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Ersin Arslan Training and Resource Hospital
Gaziantep
About this study
Official title: Incidental Cancer in Gallbladder Surgical Specimens Focus on Elderly Patients, Retrospective Analysis of 2389 Patients
Causes such as long-term stones and polyp are thought to play a role in the etiology of gallbladder cancer. The routine histopathological examination provides the detection of incidental gallbladder cancers. It should be remembered that acute or chronic cholecystitis accompanied by the thicked wall and a prolonged history of gallstones may be the cause of malignancy, especially in elderly patients.
Read the detailed description
The investigators aimed to incidental gallbladder cancer and compare other pathology results with elderly patients.
- Conditions
- Pathology
- Being tested
- Histopathological result
- Keywords
- cholecystectomy, cholecystitis, cholelithiasis, gallbladder neoplasms, histopathology, surgical procedures
- Medical subject headings
- Cholecystitis, Cholelithiasis, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histopathological resultDiagnostic test
Incidental gallbladder cancer and other pathology
| Study group | Role | What they receive |
|---|---|---|
| Elder | elderly (≥60 years old). Receives: Diagnostic Test: Histopathological result | |
| Young | young (<60 years old) Receives: Diagnostic Test: Histopathological result |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Incidental Cancer
Number of Participants with adenocarcinom
Measured: 2 or 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start20 Jan 2020
- Primary completion1 Apr 2020
- Study completion13 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PathologyStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Ersin Arslan Education and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ufuk Uylas, Dr. Ersin Arslan Education and Training Hospital
- Investigators
- Ufuk Uylas, Principal investigator, Dr. Ersin Arslan Training and Resource Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352478
- Sponsor's protocol ID
- 13042020
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidental Cancer in Gallbladder Surgical Specimens Focus on Elderly Patients, Retrospective Analysis of 2389 Patients
- ClinicalTrials.gov ID
- NCT04352478
- Acronym / sponsor ID
- 13042020
- Conditions
- Pathology
- Keywords
- cholecystectomy, cholecystitis, cholelithiasis, gallbladder neoplasms, histopathology, surgical procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,389 participants (actual)
- Lead sponsor
- Dr. Ersin Arslan Education and Training HospitalOther government
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 13 Apr 2020 (actual)
- First posted
- 20 Apr 2020 (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.
Causes such as long-term stones and polyp are thought to play a role in the etiology of gallbladder cancer. The routine histopathological examination provides the detection of incidental gallbladder cancers. It should be remembered that acute or chronic cholecystitis accompanied by the thicked wall and a prolonged history of gallstones may be the cause of malignancy, especially in elderly patients.
Detailed description
The investigators aimed to incidental gallbladder cancer and compare other pathology results with elderly patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elder | – | Diagnostic Test: Histopathological resultelderly (≥60 years old). |
| Young | – | Diagnostic Test: Histopathological resultyoung (<60 years old) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent cholecystectomy between January 2016 and February 2020 at our hospital
Key inclusion criteria (2 listed)
- acute cholecystectomy
- elective cholecystectomy
Key exclusion criteria (4 listed)
- lack of data
- incidental cholecystectomy,
- cholecystectomy secondary to trauma
- cholecystectomy secondary to malignancy
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 |
|---|---|---|
| Histopathological resultIncidental gallbladder cancer and other pathology | Diagnostic test | Elder, Young |
Primary outcome
Rate of Incidental Cancer
Time frame: 2 or 3 week
Number of Participants with adenocarcinom
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 22 Apr 2020.
- 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.
Ufuk Uylas principal investigator
Dr. Ersin Arslan Training and Resource Hospital
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 Pathology, run by Dr. Ersin Arslan Education and Training Hospital at 1 site in Turkey (Türkiye).
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 2 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 22 Apr 2020. 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 Turkey (Türkiye). 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?
Rate of Incidental Cancer (time frame: 2 or 3 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2020.