Gallbladder Neoplasm Malignant PrimaryNCT04321577
Validation of a Score That Predicts Residual Disease in Incidental Gallbladder Cancer
An observational study of Gallbladder Neoplasm Malignant Primary, run by Emilio Ramos at 1 site in Spain.
Trial summary
An incidental gallbladder carcinoma is detected in approximately 0.2% of the cholecystectomy specimens removed for presumed benign disease. In patients that meet specific criteria, a surgical re-operation is recommended to treat possible residual tumor disease not treated with the initial cholecystectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gallbladder Neoplasm Malignant Primary
- What is being tested?
- Radical surgery
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2020to Apr 2021
- How long will I take part?
- 1 Year
- 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 diagnosis of incidental gallbladder cancer that request therapeutic evaluation in the participating hospital centers.
Who may be able to join
- All consecutive patients with a diagnosis of incidental gallbladder cancer requesting therapeutic evaluation in the participating hospital centers.
Who cannot join
- All patients with non-incidental gallbladder cancer.
- All patients with incomplete or deficient data collection.
- Patients without a signed informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Prospective Validation of a Residual Disease Predictive Score in Incidental Gallbladder Cancer
An incidental gallbladder carcinoma is detected in approximately 0.2% of the cholecystectomy specimens removed for presumed benign disease. In patients that meet specific criteria, a surgical re-operation is recommended to treat possible residual tumor disease not treated with the initial cholecystectomy. The presence of residual disease in the re-intervention specimen worsens the prognosis of patient survival, according to several published series. Patients with known or high-risk of residual disease may benefit from a specific strategy that would improve patient selection before attempting re-resection. A pathology-based score has been developed but has not been yet validated in an external series of patients. The use of pathological data from the initial cholecystectomy specimen could identify patients at risk of residual disease and aid in selecting a specific therapeutic strategy prior to attempting surgical re-exploration.
Read the detailed description
- Sample size: 30 (minimum).
- Statistical analysis: populations will be compared with chi-square test or Fisher's exact test (categorical variables) and Student's t test or Mann-Whitney U test (continuous variables). A univariate and multivariate logistic regression analysis will be performed to evaluate the predictive factors of residual disease. The Kaplan-Meier method will be applied for survival analysis and curves will be compared using log-rank test. Univariate and multivariate Cox proportional hazards ratio will be applied to determine the predictive factors of survival. Variables with p values inferior to 0.1 in the univariate analysis will be used to perform the multivariate analysis. Statistical significance is defined when p < 0.5. The statistical program used will be SPSS version 23.
- Conditions
- Gallbladder Neoplasm Malignant Primary
- Being tested
- Radical surgery
- Keywords
- Residual disease, Risk score
- Medical subject headings
- Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical surgeryProcedure or surgery
Radical surgery is proposed to participants with pT1b, pT2 or pT3 tumors in the cholecystectomy specimen without evidence of disseminated disease with staging imaging techniques. A resection of the gallbladder bed or an anatomic resection of the hepatic segments IVb/V is performed. A lymphadenectomy of the hepatic hilum is associated in all cases. Common bile duct resection is performed in patients with involvement of the cystic margin.
| Study group | Role | What they receive |
|---|---|---|
| Residual disease | Participants with incidental gallbladder cancer with presence of residual disease in the re-resection specimen or in intra-operative findings. Receives: Procedure: Radical surgery | |
| No residual disease | Participants with incidental gallbladder cancer with absence of residual disease in the re-resection specimen or in intra-operative findings. Receives: Procedure: Radical surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual disease
Presence of tumoral cells in the re-resection specimen or found on staging imaging techniques. It can be local (isolated non-discontinuous involvement of the vesicular bed or the cystic stump), regional (common bile duct involvement, perineural, lymph node or neighboring organ invasion), or distant (discontinuous hepatic involvement -i.e. metastases-, peritoneal carcinomatosis or port-site metastases).
Measured: Immediately after surgery in operated patients / within 1 year in non-operated patients
Gallbladder cancer risk score
Pathology-based score that uses T stage, grade of differentiation, presence of lymphovascular and perineural invasion evaluated in the cholecystectomy specimen to pre-operatively predict the presence of residual disease after radical resection. Each factor is assigned a value. Adding these values results in a total risk score that ranges between 3 and 10 points. The scores are separated intro three risk groups: low (3-4), intermediate (5-7) and high (8-10).
Measured: Baseline
Secondary outcomes (2)
Disease-specific survival
Interval between date of surgical re-exploration and date of last follow-up or death. Only death from cancer will be considered an event in the analysis. Non-cancer related deaths will be excluded from the analysis.
Measured: 1, 3, and 5-year disease-specific survival.
Disease-free survival
Interval between date of surgical re-exploration and date of recurrence diagnosis (clinic, radiologic or pathologic) or last follow-up or death in patients without recurrence.
Measured: 1, 3, and 5-year disease-free survival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Mar 2020
- Primary completionMar 2021 (estimated)
- Study completionApr 2021 (estimated)
Why it stopped: At the beginning of the study, the collaboration of several Spanish liver surgery groups was planned. However, neither group has included a valid record. Likewise, the number of patients studied in our center has been extremely low.
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 Neoplasm Malignant PrimaryStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Emilio Ramos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emilio Ramos, Hospital Universitari de Bellvitge
- Investigators
- Laura Lladó, MD, PhD, Principal investigator, Hospital Universitari BellvitgeKristel Mills Julià, MD, Principal investigator, Hospital Universitari Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321577
- Sponsor's protocol ID
- PR357/19
- Status last verified
- Jul 2020
- First submitted
- 13 Mar 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramos E, Lluis N, Llado L, Torras J, Busquets J, Rafecas A, Serrano T, Mils K, Leiva D, Fabregat J. Prognostic value and risk stratification of residual disease in patients with incidental gallbladder cancer. World J Surg Oncol. 2020 Jan 24;18(1):18. doi: 10.1186/s12957-020-1794-2.
PubMed 31980034
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of a Residual Disease Predictive Score in Incidental Gallbladder Cancer
- ClinicalTrials.gov ID
- NCT04321577
- Acronym / sponsor ID
- PR357/19
- Conditions
- Gallbladder Neoplasm Malignant Primary
- Keywords
- Residual disease, Risk score
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: At the beginning of the study, the collaboration of several Spanish liver surgery groups was planned. However, neither group has included a valid record. Likewise, the number of patients studied in our center has been extremely low.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emilio RamosUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 25 Mar 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.
An incidental gallbladder carcinoma is detected in approximately 0.2% of the cholecystectomy specimens removed for presumed benign disease. In patients that meet specific criteria, a surgical re-operation is recommended to treat possible residual tumor disease not treated with the initial cholecystectomy. The presence of residual disease in the re-intervention specimen worsens the prognosis of patient survival, according to several published series. Patients with known or high-risk of residual disease may benefit from a specific strategy that would improve patient selection before attempting re-resection. A pathology-based score has been developed but has not been yet validated in an external series of patients. The use of pathological data from the initial cholecystectomy specimen could identify patients at risk of residual disease and aid in selecting a specific therapeutic strategy prior to attempting surgical re-exploration.
Detailed description
- Sample size: 30 (minimum).
- Statistical analysis: populations will be compared with chi-square test or Fisher's exact test (categorical variables) and Student's t test or Mann-Whitney U test (continuous variables). A univariate and multivariate logistic regression analysis will be performed to evaluate the predictive factors of residual disease. The Kaplan-Meier method will be applied for survival analysis and curves will be compared using log-rank test. Univariate and multivariate Cox proportional hazards ratio will be applied to determine the predictive factors of survival. Variables with p values inferior to 0.1 in the univariate analysis will be used to perform the multivariate analysis. Statistical significance is defined when p < 0.5. The statistical program used will be SPSS version 23.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Residual disease | – | Procedure: Radical surgeryParticipants with incidental gallbladder cancer with presence of residual disease in the re-resection specimen or in intra-operative findings. |
| No residual disease | – | Procedure: Radical surgeryParticipants with incidental gallbladder cancer with absence of residual disease in the re-resection specimen or in intra-operative findings. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diagnosis of incidental gallbladder cancer that request therapeutic evaluation in the participating hospital centers.
Key inclusion criteria (1 listed)
- All consecutive patients with a diagnosis of incidental gallbladder cancer requesting therapeutic evaluation in the participating hospital centers.
Key exclusion criteria (3 listed)
- All patients with non-incidental gallbladder cancer.
- All patients with incomplete or deficient data collection.
- Patients without a signed informed consent.
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 |
|---|---|---|
| Radical surgeryRadical surgery is proposed to participants with pT1b, pT2 or pT3 tumors in the cholecystectomy specimen without evidence of disseminated disease with staging imaging techniques. A resection of the gallbladder bed or an anatomic resection of the hepatic segments IVb/V is performed. A lymphadenectomy of the hepatic hilum is associated in all cases. Common bile duct resection is performed in patients with involvement of the cystic margin. | Procedure or surgery | No residual disease, Residual disease |
Primary outcome
Residual disease
Time frame: Immediately after surgery in operated patients / within 1 year in non-operated patients
Presence of tumoral cells in the re-resection specimen or found on staging imaging techniques. It can be local (isolated non-discontinuous involvement of the vesicular bed or the cystic stump), regional (common bile duct involvement, perineural, lymph node or neighboring organ invasion), or distant (discontinuous hepatic involvement -i.e. metastases-, peritoneal carcinomatosis or port-site metastases).
Gallbladder cancer risk score
Time frame: Baseline
Pathology-based score that uses T stage, grade of differentiation, presence of lymphovascular and perineural invasion evaluated in the cholecystectomy specimen to pre-operatively predict the presence of residual disease after radical resection. Each factor is assigned a value. Adding these values results in a total risk score that ranges between 3 and 10 points. The scores are separated intro three risk groups: low (3-4), intermediate (5-7) and high (8-10).
2 secondary outcomes
Disease-specific survival
Time frame: 1, 3, and 5-year disease-specific survival.
Disease-free survival
Time frame: 1, 3, and 5-year disease-free survival.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Results publication: PubMed 31980034Ramos E, Lluis N, Llado L, Torras J, Busquets J, Rafecas A, Serrano T, Mils K, Leiva D, Fabregat J. Prognostic value and risk stratification of residual disease in patients with incidental gallbladder cancer. World J Surg Oncol. 2020 Jan 24;18(1):18. doi: 10.1186/s12957-020-1794-2.
- Direct link to the previously cited article.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Laura Lladó, MD, PhD principal investigator
Hospital Universitari Bellvitge
Kristel Mills Julià, MD principal investigator
Hospital Universitari Bellvitge
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 Gallbladder Neoplasm Malignant Primary, run by Emilio Ramos at 1 site in Spain.
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 3 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: withdrawn, as of the sponsor's last update on 2 Sep 2021. 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 Spain. 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 was withdrawn before enrolling participants, so there are no results.
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?
Residual disease (time frame: Immediately after surgery in operated patients / within 1 year in non-operated patients). 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 NCT04321577, 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 2 Sep 2021.