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Renal Cell CarcinomaNCT03670992

Surgical Treatment of Pancreatic RCC Metastases

An observational study of Renal Cell Carcinoma and Metastases, Neoplasm, run by Azienda Policlinico Umberto I at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Data from 26 patients undergoing resection of Pancreatic Metastases and extra-Pancreatic Metastases from RCC were retrospectively analysed. Clinical data were collected from a digital database and QoL was assessed through patient's interview and Karnofsky performance scale. Read more about this study

Who is it for?
Any age
Conditions the study is for
Renal Cell Carcinoma, Metastases, Neoplasm
What is being tested?
duodenal-pancreatectomy
Type of treatment
Surgery or procedure
How many people
26 participants
Where
1 siteItaly
Study dates
10 Jan 2016to 10 Jan 2017
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: 26 patients, 12 male and 14 female age range 46 - 83, mean age 66 SD 9,1

Who may be able to join

  • metastases from RCC
  • surgically manageable lesions

Who cannot join

  • metastases from different malignancies
  • other malignancies
  • surgically unmanageable

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Department of Surgery "Pietro Valdoni"

    Roma, 00161

Other trials in Italy

About this study

Official title: Case Series: Combined, Surgical-only Treatment of Pancreatic and Extra-pancreatic Metastases From Renal Cell Carcinoma - a Quality of Life and Survival Analysis

Data from 26 patients undergoing resection of Pancreatic Metastases and extra-Pancreatic Metastases from RCC were retrospectively analysed. Clinical data were collected from a digital database and QoL was assessed through patient's interview and Karnofsky performance scale.

Read the detailed description

Retrospective data was analysed from 26 patients that were submitted to pancreatic resection between August 2002 and November 2015. Inclusion criteria were: single or multiple metastases in pancreas or extra pancreatic; primary RCC; never received chemotherapic treatment; patients that already received a previous pancreatic resection were also included.

Cases were collected from two high-volume centres: Surgical Department "Pietro Valdoni" in Policlinico Umberto I and the Division of Transplantation and General Surgery at University of Pisa.

Different kind of surgical approaches were taken into account in this study: duodenal-pancreatectomy, total-pancreatectomy and distal-pancreatectomy associated or not with other metastatic site resections. Surgery was performed either with classical open approach and modern robotic surgical approach, with the robot "Da Vinci". Aim of surgical interventions were to remove all metastases in association to radical lymphadenectomy thus to achieve R0 result. All postoperative events occurring within 90 days of surgery were considered. Postoperative complications were graded according to Clavien-Dindo classification.

Patients were followed-up 3 months after discharge and every 6 months thereafter.

Patients had blood chemistries and CT scans at least every year. A database was used to record all patients' data. Results were analysed in terms of Operative Mortality and Morbidity, Actuarial Survival, Actuarial Disease-Free Survival and Quality of Life.

Protocols were approved by the bioethical review committee and meet the guidelines of both University Sapienza of Rome and University of Pisa.

QoL was measured by Karnofsky performance scale and through Activities of Daily Living scale (ADL), Instrumental Activities of Daily living scale (IADL), BMI evaluation, serum albumin and hemoglobin, also depression was evaluated as a parameter. QoL was defined by combination of these parameters as: excellent, good, fair, poor or very poor.

A low Karnofsky scale index with inadequate social and environmental situations, a reduction in functional capacity with depression and severe weight-loss were identified as a decline in QoL.

Data was analysed via Chi-square test, as well as Student's paired and unpaired t-tests.

Actuarial relative survival and actuarial relative disease-free survival were described by Kaplan-Meier analysis. A log-rank test was used to compare continuous variables and was expressed by Kaplan-Meier curves. Homogeneity of the different groups to be compared was tested by chi-square test. Statistical significance was set at p ≤ 0,05.

Being tested
duodenal-pancreatectomy
Keywords
renal cell carcinoma, pancreatic resection, robotic surgery, pancreatic metastases, quality of life
Medical subject headings
Carcinoma, Renal Cell, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • duodenal-pancreatectomyProcedure or surgery

    Also called total-pancreatectomy, distal-pancreatectomy, other metastases resection

    surgical removal of metastatic repetitions in pancreas and/or other distal sites

Study groups in NCT03670992
Study groupRoleWhat they receive
Pancreatic MetastasesPatients with only pancreatic metastases from RCC
Receives: Procedure: duodenal-pancreatectomy
extra-pancreatic metastasespatients with extra pancreatic metastases from RCC
Receives: Procedure: duodenal-pancreatectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

    Three years survival

    Measured: follow up 36 months

  2. Survival 2

    five years survival

    Measured: follow up 60 months

  3. Survival 3

    ten years Survival

    Measured: follow up 120 months

Secondary outcomes (6)

  1. Karnofsky scale

    common scale to evaluate patient's prognosis in clinical and surgical settings. Adimensional scale in a range of 0-100. Higher Karnofsky score is associated with better outcome, score is assessed in steps of 10 (0 - 10 - 20 - 30 - 40 - 50 - 60 - 70 - 80 - 90 - 100).

    Measured: mean follow up 45 months range (6-163 months)

  2. Activity of daily living scale (ADL scale)

    prognostic scale evaluated through validated questionnaires, adimensional scale in a range of 0-6 points. evaluates abilty of the patients to fullfill the common daily activities. Better outcome is associated with higher score.

    Measured: mean follow up 45 months range (6-163 months)

  3. Instrumental Activity of daily living scale (IADL scale)

    prognostic scale evaluated through validated questionnaires, adimensional scale in a range of 0-8 points. Evaluates ability of the patient to use the common day instruments. Better outcome is associated with higher score.

    Measured: mean follow up 45 months range (6-163 months)

  4. Nutritional status

    BMI monitoring in kg/m^2

    Measured: mean follow up 45 months range (6-163 months)

  5. Serum albumin

    Serum albumin monitoring in g/dl

    Measured: mean follow up 45 months range (6-163 months)

  6. Hemoglobin

    Hemoglobin monitoring in g/dl

    Measured: mean follow up 45 months range (6-163 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start10 Jan 2016
  3. Primary completion10 Jan 2017
  4. Study completion10 Jan 2017

Resources

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
Case only
Time perspective
Retrospective
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03670992
Sponsor's protocol ID
PAN001
Status last verified
Sep 2018
First submitted
7 Sep 2018
Last updated
14 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Adler H, Redmond CE, Heneghan HM, Swan N, Maguire D, Traynor O, Hoti E, Geoghegan JG, Conlon KC. Pancreatectomy for metastatic disease: a systematic review. Eur J Surg Oncol. 2014 Apr;40(4):379-86. doi: 10.1016/j.ejso.2013.12.022. Epub 2014 Jan 15.

    PubMed 24462547

  • Tanis PJ, van der Gaag NA, Busch OR, van Gulik TM, Gouma DJ. Systematic review of pancreatic surgery for metastatic renal cell carcinoma. Br J Surg. 2009 Jun;96(6):579-92. doi: 10.1002/bjs.6606.

    PubMed 19434703

  • Grassi P, Doucet L, Giglione P, Grunwald V, Melichar B, Galli L, De Giorgi U, Sabbatini R, Ortega C, Santoni M, Bamias A, Verzoni E, Derosa L, Studentova H, Pacifici M, Coppa J, Mazzaferro V, de Braud F, Porta C, Escudier B, Procopio G. Clinical Impact of Pancreatic Metastases from Renal Cell Carcinoma: A Multicenter Retrospective Analysis. PLoS One. 2016 Apr 11;11(4):e0151662. doi: 10.1371/journal.pone.0151662. eCollection 2016.

    PubMed 27064898

  • Fikatas P, Klein F, Andreou A, Schmuck RB, Pratschke J, Bahra M. Long-term Survival After Surgical Treatment of Renal Cell Carcinoma Metastasis Within the Pancreas. Anticancer Res. 2016 Aug;36(8):4273-8.

    PubMed 27466543

  • Brozzetti S, Bini S, De Lio N, Lombardo C, Boggi U. Surgical-only treatment of pancreatic and extra-pancreatic metastases from renal cell carcinoma - quality of life and survival analysis. BMC Surg. 2020 May 13;20(1):101. doi: 10.1186/s12893-020-00757-0.

    PubMed 32404091

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Cell Carcinoma and Metastases, Neoplasm, run by Azienda Policlinico Umberto I at 1 site in Italy.

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 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: finished, as of the sponsor's last update on 14 Sep 2018. 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 Italy. 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?

Survival (time frame: follow up 36 months). The study lists 3 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 NCT03670992, which also lists 5 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 14 Sep 2018.

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