Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-02-20 @ 4:46 PM
Study NCT ID:
NCT03659292
Status:
UNKNOWN
Last Update Posted:
2018-09-06
First Post:
2018-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D000767', 'term': 'Anesthesia, Epidural'}, {'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 540}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-03', 'studyFirstSubmitDate': '2018-09-03', 'studyFirstSubmitQcDate': '2018-09-03', 'lastUpdatePostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'During 2 years after surgery', 'description': 'Defined and calculated as the time from the date of surgery to death related to all reasons'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival (DFS )', 'timeFrame': 'During 2 years after surgery', 'description': 'Defined and calculated as the time from the date of surgery to the first time of pancreatic cancer recurrence or metastasis or cancer-related death'}, {'measure': 'Postoperative pain score and side effects of patient-controlled analgesia', 'timeFrame': 'During the first 48 hours after surgery', 'description': 'Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)'}, {'measure': 'Incidence of delirium', 'timeFrame': 'During the first 1 week after surgery', 'description': 'Assessed for delirium using the 3D-CAM instrument'}, {'measure': 'Incidence of persistent post-surgical pain (PPSP) after surgery', 'timeFrame': 'During 2 years after surgery', 'description': 'Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)'}, {'measure': 'Length of stay in hospital after surgery', 'timeFrame': 'During the first 30 days after surgery'}, {'measure': 'Return of bowel function', 'timeFrame': 'During the first 30 days after surgery', 'description': 'Measured by the time of first flatus'}, {'measure': 'Removal of Perianastomotic drains', 'timeFrame': 'During the first 30 days after surgery'}, {'measure': 'Removal of Urinary drainage', 'timeFrame': 'During the first 30 days after surgery'}, {'measure': 'Removal of nasogastric tube', 'timeFrame': 'During the first 30 days after surgery'}, {'measure': 'Blood level of neuroendocrine, stress and inflammatory response', 'timeFrame': 'During surgery and the first 24 hours after surgery', 'description': 'Changes of blood epinephrine, norepinephrine, cortisol, VEGF, interleukin-6 (IL-6)、interleukin-8 (IL-8), peripheral blood NLR ( neutrophil-lymphocyte ratio)'}, {'measure': 'Blood CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels', 'timeFrame': 'During 2 years after surgery'}, {'measure': 'Blood levels of ropivacaine and sufentanil', 'timeFrame': 'During surgery and the first 24 hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epidural block', 'Pancreatic cancer'], 'conditions': ['Cancer of Pancreas']}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized controlled clinical trial is to investigate the effects of epidural block on overall survival，disease-free survival and recovery in patients with pancreatic cancer undergoing distal pancreatectomy. This study will also evaluate the effects of this technique on neuroendocrine, stress and inflammatory response in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Undergoing elective distal pancreatectomy for pancreatic cancer .\n2. ASA statusⅠ-Ⅲ.\n3. 18 years to 80 years （adults）.\n4. Able to understand, communicate and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Laparoscopic surgery.\n2. Preoperative chemotherapy or radiotherapy.\n3. Pregnancy.\n4. Allergic to any drugs used during the study.\n5. Long-term receiving β-blockers.\n6. Complicated with chronic inflammatory diseases, autoimmune diseases, or long-term receiving glucocorticoids or other immunosuppressants before surgery.\n7. Abnormal coagulation functions (platelet count prior to surgery \\<100000/ μL , APTT value is more than the normal value, INR \\> 1.3 or clopidogrel that cannot be discontinued 7 days prior to surgery).\n8. Complicated with severe heart disease (NYHA classification \\>3), severe renal insufficiency (serum creatinine \\>1.8mg/dL or receiving renal replacement therapy), severe hepatic disease (Child-Pugh classification=C), diabetes (fasting blood glucose not in the range of 3.9-13.8 mmol/L ), or acute infectious diseases (WBC\\>10000/μL) before surgery.\n9. BMI \\> 35.\n10. All contraindications to epidural block.\n11. Chronic opiate medication/drug abuse.\n12. Complicated with severe mental illness, cognitive disorder or unable to collaborate during the study.\n13. Refuse to sign an informed consent form.'}, 'identificationModule': {'nctId': 'NCT03659292', 'briefTitle': 'Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy----A Multi-center Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FDUSCCA-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GEA+PCEA', 'description': 'General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery.', 'interventionNames': ['Other: GEA', 'Other: PCEA']}, {'type': 'OTHER', 'label': 'GA+PCIA', 'description': 'General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery.', 'interventionNames': ['Other: GA', 'Other: PCIA']}], 'interventions': [{'name': 'GEA', 'type': 'OTHER', 'otherNames': ['General anesthesia combined with epidural anesthesia'], 'description': 'Thoracic epidural catheterization will be performed and epidural anesthesia will be maintained with 0.25% ropivacaine during surgery. General anesthesia will be maintained with inhalation (sevoflurane) and muscle relaxants will be administered when considered necessary.', 'armGroupLabels': ['GEA+PCEA']}, {'name': 'PCEA', 'type': 'OTHER', 'otherNames': ['Patient-controlled epidural analgesia'], 'description': 'Patient-controlled epidural analgesia (0.15% ropivacaine and 0.5ug/ml sufentanil infusion) will be provided after surgery.', 'armGroupLabels': ['GEA+PCEA']}, {'name': 'GA', 'type': 'OTHER', 'otherNames': ['General anesthesia'], 'description': 'General anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary.', 'armGroupLabels': ['GA+PCIA']}, {'name': 'PCIA', 'type': 'OTHER', 'otherNames': ['Patient-controlled intravenous analgesia'], 'description': 'Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery.', 'armGroupLabels': ['GA+PCIA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Changhong Miao', 'role': 'CONTACT', 'email': 'miaochh@aliyun.com', 'phone': '+86-021-64175590', 'phoneExt': '82420'}, {'name': 'Xuqin Zhu', 'role': 'CONTACT', 'email': 'zhuxuqin1101@sina.com', 'phone': '+86-021-64175590', 'phoneExt': '82420'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Jing Cang', 'role': 'CONTACT', 'email': 'cangjing1998@aliyun.com', 'phone': '+86-139-1601-0421'}], 'facility': 'Fudan University Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Yingwei Wang', 'role': 'CONTACT', 'email': 'wangyingwei@yahoo.com', 'phone': '+86-139-1869-0528'}], 'facility': 'Fudan University Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Changhong Miao', 'role': 'CONTACT', 'email': 'miaochh@aliyun.com', 'phone': '+86-021-64175590', 'phoneExt': '82420'}, {'name': 'Xuqin Zhu', 'role': 'CONTACT', 'email': 'zhuxuqin1101@sina.com', 'phone': '+86-021-64175590', 'phoneExt': '82420'}], 'overallOfficials': [{'name': 'Changhong Miao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}, {'name': 'Qianjin Liu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Washington University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Anesthesiology Department of Fudan University Shanghai Cancer Center', 'investigatorFullName': 'Changhong Miao', 'investigatorAffiliation': 'Fudan University'}}}}