Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT04358718
Status:
COMPLETED
Last Update Posted:
2021-08-09
First Post:
2020-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D015360', 'term': 'Analgesia, Epidural'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000698', 'term': 'Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-01', 'studyFirstSubmitDate': '2020-04-19', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of circulating tumor cells', 'timeFrame': 'on the 3rd day after surgery', 'description': 'The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.'}], 'secondaryOutcomes': [{'measure': 'the number of circulating tumor cells', 'timeFrame': 'immediately after the surgery', 'description': 'The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.'}, {'measure': 'the number of circulating tumor cells', 'timeFrame': 'on the 30 day after surgery', 'description': 'The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.'}, {'measure': 'Visual Analogue Scale', 'timeFrame': 'at 24 hours after surgery', 'description': 'Pain intensity will be assessed using the Visual Analogue Scale, which ranges from 0 to 10, with a higher score indicating greater pain intensity at 24 hours after surgery.'}, {'measure': 'Visual Analogue Scale', 'timeFrame': 'at 48 hours after surgery', 'description': 'Pain intensity will be assessed using the Visual Analogue Scale, which ranges from 0 to 10, with a higher score indicating greater pain intensity at 48 hours after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Circulating tumor cells', 'Opioid', 'Epidural anesthesia', 'Radical cystectomy'], 'conditions': ['Bladder Cancer']}, 'referencesModule': {'references': [{'pmid': '36739595', 'type': 'DERIVED', 'citation': 'Wang X, Zhang S, Jin D, Luo J, Shi Y, Zhang Y, Wu L, Song Y, Su D, Pan Z, Chen H, Cao M, Yang C, Yu W, Tian J. mu-opioid receptor agonist facilitates circulating tumor cell formation in bladder cancer via the MOR/AKT/Slug pathway: a comprehensive study including randomized controlled trial. Cancer Commun (Lond). 2023 Mar;43(3):365-386. doi: 10.1002/cac2.12408. Epub 2023 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'Multiple lines of evidence have shown that perioperative opioids requirement was associated with poor outcomes in cancer patients, including increased cancer progression and metastases and reduced survival in patients with lung, breast, prostate, and bladder cancer. Circulating tumor cells (CTCs) have been validated as prognostic biomarkers of a number of cancers. The aim of this study is to investigate the effects of perioperative opioids on the number of CTCs in patients receiving robot-assisted laparoscopic radical cystectomy. The difference of the amounts of perioperative opioids is achieved by using general anesthesia combined with intravenous opioid-based analgesia intra- and post-operatively in one group and general analgesia combined with epidural ropivacaine-based analgesia in the other group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>=18\n* ASA I-II\n* Patients with primary bladder cancer of Stage T2a or higher, who are scheduled for robot-assisted laparoscopic radical cystectomy\n* Written informed consent\n\nExclusion Criteria:\n\n* Emergency surgery\n* Palliative surgery\n* Contraindications for epidural anesthesia\n* Metastatic bladder cancer\n* Patients with a history of any other malignancy\n* Chronic opioids medication\n* severe systemic disease (heart, lung, kidney, or immune system)\n* Known hypersensitivity or suspected allergy to intervention drugs\n* Intellectual Disability'}, 'identificationModule': {'nctId': 'NCT04358718', 'briefTitle': 'Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Influence of Peri-operative Opioids on Circulating Tumor Cells in Patients Undergoing Robot-Assisted Laparoscopic Radical Cystectomy', 'orgStudyIdInfo': {'id': 'CTC20200417'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'general anesthesia', 'description': 'Patients in this group will receive general anesthesia with intraoperative and postoperative intravenous opioid-based analgesia.', 'interventionNames': ['Procedure: general anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'general analgesia combined with epidural analgesia', 'description': 'Patients in this group will receive combined epidural and general anesthesia with intraoperative and postoperative epidural ropivacaine-based analgesia.', 'interventionNames': ['Procedure: general anesthesia combined with epidural analgesia']}], 'interventions': [{'name': 'general anesthesia', 'type': 'PROCEDURE', 'description': 'Patients will receive intraoperative and postoperative intravenous opioid-based analgesia for robot-assisted laparoscopic radical cystectomy.', 'armGroupLabels': ['general anesthesia']}, {'name': 'general anesthesia combined with epidural analgesia', 'type': 'PROCEDURE', 'description': 'Patients will receive epidural ropivacaine-based analgesia for robot-assisted laparoscopic radical cystectomy.', 'armGroupLabels': ['general analgesia combined with epidural analgesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji hospital, School of Medicine, Shanghai Jiaotong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jie Tian', 'investigatorAffiliation': 'RenJi Hospital'}}}}