Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02335151
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2014-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CTC Pancreatic Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077335', 'term': 'Desflurane'}], 'ancestors': [{'id': 'D005019', 'term': 'Ethyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-12', 'studyFirstSubmitDate': '2014-12-13', 'studyFirstSubmitQcDate': '2015-01-08', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak of CTC in the postoperative phase after curative tumor removal', 'timeFrame': 'Day 0 to Day 7', 'description': 'CTC will be counted and peak of CTC will be determined.'}], 'secondaryOutcomes': [{'measure': 'Kinetics of CTC after surgery up to day 7', 'timeFrame': '1 year', 'description': 'CTC will be counted and kinetics of CTC will be determined.'}, {'measure': 'Month to Tumor recurrence', 'timeFrame': '1 year', 'description': 'Tumor recurrence will be monitored.'}, {'measure': 'Number of surviving patients', 'timeFrame': '1 year', 'description': 'One year after surgery the number of patients still being alive will be determined.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Circulating Tumor Cells', 'Anesthesia and immunity', 'Cell Search System'], 'conditions': ['Adenocarcinoma', 'Circulating Tumor Cells', 'Pancreatic Neoplasms']}, 'descriptionModule': {'briefSummary': 'Proportion of circulating tumor cells (CTC) in the postoperative phase after curative tumor removal of pancreatic cancer will be determined and correlated to the accordance of anesthesia (desflurane versus propofol)', 'detailedDescription': 'This prospective, randomized study will be conducted over a 36-month period to investigate whether commonly used anesthetics (volatile versus intravenous) have an effect on the changes or occurrence of CTC in patients suffering from primary pancreatic cancer undergoing curative surgery. The specific research question is if there are changes of the CTC count in the postoperative phase in the desflurane group (intervention) compared to the propofol one (control). A secondary question is if these changes can be correlated to tumor outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 85\n* ASA I-III ( American Society of Anesthesiologists)\n* Resectable pancreatic adenocarcinoma\n* Primary surgery\n* No neoadjuvant therapy\n* Written informed consent\n\nExclusion Criteria:\n\n* Metastatic disease\n* Other than primary surgery (recurrence, reconstruction)\n* Pre-operative chemotherapy\n* Chronic opioid use\n* Known hypersensitivity or suspected allergy to propofol, soya or egg proteins\n* Known hypersensitivity to volatile anaesthetics (malignant hyperthermia)\n* Pregnancy\n* Breast feeding\n* Enrolment in any other clinical trial during the course of this trial, 30 days prior to its beginning or 30 days after its completion'}, 'identificationModule': {'nctId': 'NCT02335151', 'briefTitle': 'CTC Pancreatic Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Resectable Pancreatic Adenocarcinoma - Does the Type of Anesthesia Have an Impact on Circulating Tumor Cells?', 'orgStudyIdInfo': {'id': '2016 -00448'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desflurane', 'description': 'General anesthesia with Desflurane', 'interventionNames': ['Drug: Desflurane']}, {'type': 'NO_INTERVENTION', 'label': 'Propofol', 'description': 'General anesthesia with Propofol'}], 'interventions': [{'name': 'Desflurane', 'type': 'DRUG', 'otherNames': ['Suprane'], 'description': 'Apply desflurane as anesthetic', 'armGroupLabels': ['Desflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Kantonsspital St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '8401', 'city': 'Winterthur', 'country': 'Switzerland', 'facility': 'Kantonsspital Winterthur', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}, {'zip': '8063', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Stadtspital Triemli', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Beatrice Beck Schimmer, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kantonsspital Winterthur KSW', 'class': 'OTHER'}, {'name': 'Triemli Hospital', 'class': 'OTHER'}, {'name': 'Cantonal Hospital of St. Gallen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}