Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-03-04 @ 1:39 PM
Study NCT ID:
NCT03670992
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2018-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Treatment of Pancreatic RCC Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-13', 'studyFirstSubmitDate': '2018-09-07', 'studyFirstSubmitQcDate': '2018-09-13', 'lastUpdatePostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'follow up 36 months', 'description': 'Three years survival'}, {'measure': 'Survival 2', 'timeFrame': 'follow up 60 months', 'description': 'five years survival'}, {'measure': 'Survival 3', 'timeFrame': 'follow up 120 months', 'description': 'ten years Survival'}], 'secondaryOutcomes': [{'measure': 'Karnofsky scale', 'timeFrame': 'mean follow up 45 months range (6-163 months)', 'description': "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)."}, {'measure': 'Activity of daily living scale (ADL scale)', 'timeFrame': 'mean follow up 45 months range (6-163 months)', 'description': '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.'}, {'measure': 'Instrumental Activity of daily living scale (IADL scale)', 'timeFrame': 'mean follow up 45 months range (6-163 months)', 'description': '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.'}, {'measure': 'Nutritional status', 'timeFrame': 'mean follow up 45 months range (6-163 months)', 'description': 'BMI monitoring in kg/m\\^2'}, {'measure': 'Serum albumin', 'timeFrame': 'mean follow up 45 months range (6-163 months)', 'description': 'Serum albumin monitoring in g/dl'}, {'measure': 'Hemoglobin', 'timeFrame': 'mean follow up 45 months range (6-163 months)', 'description': 'Hemoglobin monitoring in g/dl'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['renal cell carcinoma', 'pancreatic resection', 'robotic surgery', 'pancreatic metastases', 'quality of life'], 'conditions': ['Renal Cell Carcinoma', 'Metastases, Neoplasm']}, 'referencesModule': {'references': [{'pmid': '24462547', 'type': 'RESULT', 'citation': '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': '19434703', 'type': 'RESULT', 'citation': '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': '27064898', 'type': 'RESULT', 'citation': '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': '27466543', 'type': 'RESULT', 'citation': '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': '32404091', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nCases 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.\n\nDifferent 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.\n\nPatients were followed-up 3 months after discharge and every 6 months thereafter.\n\nPatients 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.\n\nProtocols were approved by the bioethical review committee and meet the guidelines of both University Sapienza of Rome and University of Pisa.\n\nQoL 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.\n\nA 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.\n\nData was analysed via Chi-square test, as well as Student\'s paired and unpaired t-tests.\n\nActuarial 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '26 patients, 12 male and 14 female age range 46 - 83, mean age 66 SD 9,1', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* metastases from RCC\n* surgically manageable lesions\n\nExclusion Criteria:\n\n* metastases from different malignancies\n* other malignancies\n* surgically unmanageable'}, 'identificationModule': {'nctId': 'NCT03670992', 'briefTitle': 'Surgical Treatment of Pancreatic RCC Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Policlinico Umberto I'}, 'officialTitle': 'Case Series: Combined, Surgical-only Treatment of Pancreatic and Extra-pancreatic Metastases From Renal Cell Carcinoma - a Quality of Life and Survival Analysis', 'orgStudyIdInfo': {'id': 'PAN001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pancreatic Metastases', 'description': 'Patients with only pancreatic metastases from RCC', 'interventionNames': ['Procedure: duodenal-pancreatectomy']}, {'label': 'extra-pancreatic metastases', 'description': 'patients with extra pancreatic metastases from RCC', 'interventionNames': ['Procedure: duodenal-pancreatectomy']}], 'interventions': [{'name': 'duodenal-pancreatectomy', 'type': 'PROCEDURE', 'otherNames': ['total-pancreatectomy', 'distal-pancreatectomy', 'other metastases resection'], 'description': 'surgical removal of metastatic repetitions in pancreas and/or other distal sites', 'armGroupLabels': ['Pancreatic Metastases', 'extra-pancreatic metastases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'Department of Surgery "Pietro Valdoni"', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Stefania Brozzetti, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Policlinico Umberto I'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Policlinico Umberto I', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Professor Stefania Brozzetti', 'investigatorAffiliation': 'Azienda Policlinico Umberto I'}}}}