NCT03670992

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

September 7, 2018

Last Update Submit

September 13, 2018

Conditions

Renal Cell CarcinomaMetastases, Neoplasm

Keywords

renal cell carcinomapancreatic resectionrobotic surgerypancreatic metastasesquality of life

Outcome Measures

Primary Outcomes (3)

  • Survival

    Three years survival

    follow up 36 months

  • Survival 2

    five years survival

    follow up 60 months

  • Survival 3

    ten years Survival

    follow up 120 months

Secondary Outcomes (6)

  • Karnofsky scale

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

  • Activity of daily living scale (ADL scale)

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

  • Instrumental Activity of daily living scale (IADL scale)

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

  • Nutritional status

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

  • Serum albumin

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

  • +1 more secondary outcomes

Study Arms (2)

Pancreatic Metastases

Patients with only pancreatic metastases from RCC

Procedure: duodenal-pancreatectomy

extra-pancreatic metastases

patients with extra pancreatic metastases from RCC

Procedure: duodenal-pancreatectomy

Interventions

duodenal-pancreatectomyPROCEDURE

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

Also known as: total-pancreatectomy, distal-pancreatectomy, other metastases resection
Pancreatic Metastasesextra-pancreatic metastases

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

26 patients, 12 male and 14 female age range 46 - 83, mean age 66 SD 9,1

You may qualify if:

  • metastases from RCC
  • surgically manageable lesions

You may not qualify if:

  • metastases from different malignancies
  • other malignancies
  • surgically unmanageable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery "Pietro Valdoni"

Roma, 00161, Italy

Location

Related Publications (5)

  • 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.

    PMID: 24462547RESULT

  • 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.

    PMID: 19434703RESULT

  • 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.

    PMID: 27064898RESULT

  • 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.

    PMID: 27466543RESULT

  • 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.

    PMID: 32404091DERIVED

MeSH Terms

Conditions

Carcinoma, Renal CellNeoplasm Metastasis

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stefania Brozzetti, professor

    Policlinico Umberto I

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 14, 2018

Study Start

January 10, 2016

Primary Completion

January 10, 2017

Study Completion

January 10, 2017

Last Updated

September 14, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)