Surgical ProcedurePANMEKIDNCT04245410
Surgical Treatment of Pancreatic Metastases From Renal Cell Carcinoma
An observational study of Surgical Procedure and Disease Free Survival, run by Universidad de Extremadura at 1 site in Spain.
Trial summary
Pancreatic metastases are a rare entity. In cases of metastatic renal carcinoma (RCC) it can present as isolated pancreatic metastasis, considering the possibility of surgical resection. Goals: Define survival after resection of pancreatic cancer metastases renal in a wide range of our country. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Procedure, Disease Free Survival, Overall Survival
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2019to 31 Jul 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients operated from renal cell carcinoma in the past that have developed pancreatic metastases. They are included in the study after pancreatic resection.
Who may be able to join
- Patients with resecable pancreatic metastases from RCC
Who cannot join
- Unresecable pancreatic metastases
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Gerardo Blanco-Fernández
Badajoz, 06080
Gerardo Blanco-Fernández, MD
About this study
Pancreatic metastases are a rare entity. In cases of metastatic renal carcinoma (RCC) it can present as isolated pancreatic metastasis, considering the possibility of surgical resection.
Goals:
- Define survival after resection of pancreatic cancer metastases renal in a wide range of our country.
- Identify predictive survival factors
Methods:
Retrospective multicenter study in which cases of pancreatic resection due to renal cancer metastases.
Read the detailed description
Introduction:
Pancreatic metastases are a rare entity and often synonymous with broader dissemination. However, in cases of metastatic renal carcinoma (RCC) it can present as isolated pancreatic metastasis, considering the possibility of surgical resection. Most of the literature refers to isolated cases or short series, with the Johns Hopkins Hospital series being the largest in a single published center (1,2). In all of them, survival after resection is prolonged.
Recently, due to the results obtained with the tyrosine kinase inhibitor drugs, the value of resection of metastases of RCC origin has been questioned in an Italian multicenter study (3), although other studies consider that resection can improve the prognosis if It is associated with these drugs (4).
Justification:
The existing literature is limited to short series or mostly isolated cases. There are no clear prognostic factors that are limited in most cases to being merely descriptive studies.
Goals:
- Define survival after resection of pancreatic cancer metastases renal in a wide range of our country.
- Identify predictive survival factors that allow establishing Subgroups of patients with the greatest benefit after surgery or, conversely, those who potentially do not benefit from drug treatment.
Method:
Retrospective multicenter study in which cases of pancreatic resection due to renal cancer metastases are collected until December 2019, identified by each of the centers included in the study. A data collection sheet has been designed for each case that will be sent to the participating centers. To know which centers could have performed some pancreatic resection due to renal cancer metastases, an email has been sent to all members of the Spanish association of surgeons and Spanish members of International Hepato-pancreatic and biliary surgery association and this information has been included on their websites. The study variables include those related to demographic data of the patient, with the primary tumor, with the presentation of pancreatic metastasis, pancreas surgery and short-term and long-term postoperative follow-up.
Statistic analysis The data will be analyzed using the IBM SPSS Statistics for Mac version 22.0 program (IBM Corp., Orchard Road Armonk, New York, US). Student's t, Mann Whitney U, Chi-square, or Fisher's test will be used according to the parameters studied. Categorical data will be presented as frequency and percentage. Continuous data will be presented as mean and standard deviation or median and interquartile range depending on the distribution of the data. Subgroups created to compare characteristics and results will be measured using Mann Whitney U, Chi-square or Kruskal Wallis test. A p <0.05 will be considered statistically significant.
Limitations of the study:
The main limitation is the retrospective and multicenter nature that can lead to selection or information bias.
- Conditions
- Surgical Procedure, Disease Free Survival, Overall Survival
- Keywords
- Renal cell carcinoma, Pancreatic metastases, Resection
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients surgically treated of pancreatic metastases from RCC | Patients surgically treated of pancreatic metastases from renal cell carcinoma. Pancreaticoduodenectomy, distal pancreatectomy or total pancreatectomy are included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival (months) from surgical resection of pancreatic metastases
Measured: Up to 60 months
Disease free survival
Disease free survival (months) from surgical resection of pancreatic metastases
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Mar 2019
- Primary completion1 Mar 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Surgical ProcedureStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerardo Blanco-Fernández, Universidad de Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245410
- Sponsor's protocol ID
- UE-CHUB 001-2020
- Acronym
- PANMEKID
- Status last verified
- Nov 2020
- First submitted
- 25 Jan 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tosoian JJ, Cameron JL, Allaf ME, Hruban RH, Nahime CB, Pawlik TM, Pierorazio PM, Reddy S, Wolfgang CL. Resection of isolated renal cell carcinoma metastases of the pancreas: outcomes from the Johns Hopkins Hospital. J Gastrointest Surg. 2014 Mar;18(3):542-8. doi: 10.1007/s11605-013-2278-2. Epub 2013 Oct 26.
PubMed 24163138Lee SR, Gemenetzis G, Cooper M, Javed AA, Cameron JL, Wolfgang CL, Eckhauser FE, He J, Weiss MJ. Long-Term Outcomes of 98 Surgically Resected Metastatic Tumors in the Pancreas. Ann Surg Oncol. 2017 Mar;24(3):801-807. doi: 10.1245/s10434-016-5619-z. Epub 2016 Oct 21.
PubMed 27770346Santoni M, Conti A, Partelli S, Porta C, Sternberg CN, Procopio G, Bracarda S, Basso U, De Giorgi U, Derosa L, Rizzo M, Ortega C, Massari F, Iacovelli R, Milella M, Di Lorenzo G, Buti S, Cerbone L, Burattini L, Montironi R, Santini D, Falconi M, Cascinu S. Surgical resection does not improve survival in patients with renal metastases to the pancreas in the era of tyrosine kinase inhibitors. Ann Surg Oncol. 2015;22(6):2094-100. doi: 10.1245/s10434-014-4256-7. Epub 2014 Dec 4.
PubMed 25472645Chang YH, Liaw CC, Chuang CK. The role of surgery in renal cell carcinoma with pancreatic metastasis. Biomed J. 2015 Mar-Apr;38(2):173-6. doi: 10.4103/2319-4170.137771.
PubMed 25179721
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Pancreatic Metastases From Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04245410
- Acronym / sponsor ID
- PANMEKID / UE-CHUB 001-2020
- Conditions
- Surgical Procedure, Disease Free Survival, Overall Survival
- Keywords
- Renal cell carcinoma, Pancreatic metastases, Resection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 28 Jan 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.
Pancreatic metastases are a rare entity. In cases of metastatic renal carcinoma (RCC) it can present as isolated pancreatic metastasis, considering the possibility of surgical resection.
Goals:
- Define survival after resection of pancreatic cancer metastases renal in a wide range of our country.
- Identify predictive survival factors
Methods:
Retrospective multicenter study in which cases of pancreatic resection due to renal cancer metastases.
Detailed description
Introduction:
Pancreatic metastases are a rare entity and often synonymous with broader dissemination. However, in cases of metastatic renal carcinoma (RCC) it can present as isolated pancreatic metastasis, considering the possibility of surgical resection. Most of the literature refers to isolated cases or short series, with the Johns Hopkins Hospital series being the largest in a single published center (1,2). In all of them, survival after resection is prolonged.
Recently, due to the results obtained with the tyrosine kinase inhibitor drugs, the value of resection of metastases of RCC origin has been questioned in an Italian multicenter study (3), although other studies consider that resection can improve the prognosis if It is associated with these drugs (4).
Justification:
The existing literature is limited to short series or mostly isolated cases. There are no clear prognostic factors that are limited in most cases to being merely descriptive studies.
Goals:
- Define survival after resection of pancreatic cancer metastases renal in a wide range of our country.
- Identify predictive survival factors that allow establishing Subgroups of patients with the greatest benefit after surgery or, conversely, those who potentially do not benefit from drug treatment.
Method:
Retrospective multicenter study in which cases of pancreatic resection due to renal cancer metastases are collected until December 2019, identified by each of the centers included in the study. A data collection sheet has been designed for each case that will be sent to the participating centers. To know which centers could have performed some pancreatic resection due to renal cancer metastases, an email has been sent to all members of the Spanish association of surgeons and Spanish members of International Hepato-pancreatic and biliary surgery association and this information has been included on their websites. The study variables include those related to demographic data of the patient, with the primary tumor, with the presentation of pancreatic metastasis, pancreas surgery and short-term and long-term postoperative follow-up.
Statistic analysis The data will be analyzed using the IBM SPSS Statistics for Mac version 22.0 program (IBM Corp., Orchard Road Armonk, New York, US). Student's t, Mann Whitney U, Chi-square, or Fisher's test will be used according to the parameters studied. Categorical data will be presented as frequency and percentage. Continuous data will be presented as mean and standard deviation or median and interquartile range depending on the distribution of the data. Subgroups created to compare characteristics and results will be measured using Mann Whitney U, Chi-square or Kruskal Wallis test. A p <0.05 will be considered statistically significant.
Limitations of the study:
The main limitation is the retrospective and multicenter nature that can lead to selection or information bias.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients surgically treated of pancreatic metastases from RCC | – | –Patients surgically treated of pancreatic metastases from renal cell carcinoma. Pancreaticoduodenectomy, distal pancreatectomy or total pancreatectomy are included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated from renal cell carcinoma in the past that have developed pancreatic metastases. They are included in the study after pancreatic resection.
Key inclusion criteria (1 listed)
- Patients with resecable pancreatic metastases from RCC
Key exclusion criteria (1 listed)
- Unresecable pancreatic metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: Up to 60 months
Overall survival (months) from surgical resection of pancreatic metastases
Disease free survival
Time frame: Up to 60 months
Disease free survival (months) from surgical resection of pancreatic metastases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Background: PubMed 24163138Tosoian JJ, Cameron JL, Allaf ME, Hruban RH, Nahime CB, Pawlik TM, Pierorazio PM, Reddy S, Wolfgang CL. Resection of isolated renal cell carcinoma metastases of the pancreas: outcomes from the Johns Hopkins Hospital. J Gastrointest Surg. 2014 Mar;18(3):542-8. doi: 10.1007/s11605-013-2278-2. Epub 2013 Oct 26.
- Background: PubMed 27770346Lee SR, Gemenetzis G, Cooper M, Javed AA, Cameron JL, Wolfgang CL, Eckhauser FE, He J, Weiss MJ. Long-Term Outcomes of 98 Surgically Resected Metastatic Tumors in the Pancreas. Ann Surg Oncol. 2017 Mar;24(3):801-807. doi: 10.1245/s10434-016-5619-z. Epub 2016 Oct 21.
- Background: PubMed 25472645Santoni M, Conti A, Partelli S, Porta C, Sternberg CN, Procopio G, Bracarda S, Basso U, De Giorgi U, Derosa L, Rizzo M, Ortega C, Massari F, Iacovelli R, Milella M, Di Lorenzo G, Buti S, Cerbone L, Burattini L, Montironi R, Santini D, Falconi M, Cascinu S. Surgical resection does not improve survival in patients with renal metastases to the pancreas in the era of tyrosine kinase inhibitors. Ann Surg Oncol. 2015;22(6):2094-100. doi: 10.1245/s10434-014-4256-7. Epub 2014 Dec 4.
- Background: PubMed 25179721Chang YH, Liaw CC, Chuang CK. The role of surgery in renal cell carcinoma with pancreatic metastasis. Biomed J. 2015 Mar-Apr;38(2):173-6. doi: 10.4103/2319-4170.137771.
- 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.
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 Surgical Procedure and Disease Free Survival, run by Universidad de Extremadura 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 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: status not confirmed, as of the sponsor's last update on 3 Nov 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerardo Blanco-Fernandez, MD (0034924218022, gerardoblanco@unex.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Up to 60 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 NCT04245410, which also lists 4 linked publications.
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 Nov 2020.