Gallbladder CancerNCT06189664
Evaluation of the Effectiveness of Intraoperative Frozen Section on the Treatment of Suspected Gallbladder Cancer
An observational study of Gallbladder Cancer, run by Imperial College London.
Trial summary
Evaluate the effectiveness of intra-operative frozen section in the treatment of gallbladder cancer. The study will be looking in to identify if intraoperative frozen section is a viable method to intraoperatively evaluate the presence of adenocarcinoma and the depth of its invasion and if the information given by… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gallbladder Cancer
- What is being tested?
- Frozen section
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 31 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 with suspected GB Cancer
Who may be able to join
- Patients with suspected GB cancer
Who cannot join
- -
About this study
Evaluate the effectiveness of intra-operative frozen section in the treatment of gallbladder cancer.
The study will be looking in to identify if intraoperative frozen section is a viable method to intraoperatively evaluate the presence of adenocarcinoma and the depth of its invasion and if the information given by frozen section is enough to modify the operative strategy.
- Conditions
- Gallbladder Cancer
- Being tested
- Frozen section
- Medical subject headings
- Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frozen sectionDiagnostic test
Frozen section analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of adenocarcinoma
Measured: immediately during frozen section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Jan 2013
- Primary completion31 Dec 2020
- Study completion31 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 Gallbladder CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189664
- Sponsor's protocol ID
- Gen_17/2020
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Banh S, Fehervari M, Flod S, Soleimani-Nouri P, Leyte Golpe A, Ahmad R, Pai M, Spalding DRC. Single stage management of suspected gallbladder cancer guided by intraoperative frozen section analysis: a retrospective cohort study. Int J Surg. 2024 Oct 1;110(10):6314-6320. doi: 10.1097/JS9.0000000000001456.
PubMed 38704628
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Intraoperative Frozen Section on the Treatment of Suspected Gallbladder Cancer
- ClinicalTrials.gov ID
- NCT06189664
- Acronym / sponsor ID
- Gen_17/2020
- Conditions
- Gallbladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 3 Jan 2024 (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.
Evaluate the effectiveness of intra-operative frozen section in the treatment of gallbladder cancer.
The study will be looking in to identify if intraoperative frozen section is a viable method to intraoperatively evaluate the presence of adenocarcinoma and the depth of its invasion and if the information given by frozen section is enough to modify the operative strategy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected GB Cancer
Key inclusion criteria (1 listed)
- Patients with suspected GB cancer
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Frozen sectionFrozen section analysis | Diagnostic test | – |
Primary outcome
Detection of adenocarcinoma
Time frame: immediately during frozen section
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 3 Jan 2024.
- Derived from this study: PubMed 38704628Banh S, Fehervari M, Flod S, Soleimani-Nouri P, Leyte Golpe A, Ahmad R, Pai M, Spalding DRC. Single stage management of suspected gallbladder cancer guided by intraoperative frozen section analysis: a retrospective cohort study. Int J Surg. 2024 Oct 1;110(10):6314-6320. doi: 10.1097/JS9.0000000000001456.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallbladder Cancer, run by Imperial College London.
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 1 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Detection of adenocarcinoma (time frame: immediately during frozen section). 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 NCT06189664, 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 3 Jan 2024.