Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2026-02-26 @ 8:11 PM
Study NCT ID:
NCT02002806
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2013-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}], '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'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-14', 'studyFirstSubmitDate': '2013-12-02', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Control', 'timeFrame': '12 Months'}], 'secondaryOutcomes': [{'measure': 'Disease-specific, recurrence-free survival', 'timeFrame': '2 Years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pancreatic cancer', 'Pain'], 'conditions': ['Pancreas Cancer', 'Biliary Tract Cancer']}, 'descriptionModule': {'briefSummary': 'This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo for pain control in subjects with pancreatic cancer.', 'detailedDescription': 'Thi is a study of pain control in subjects undergoing surgery for pancreatic or bile duct cancer.\n\nSubjects undergoing surgery will be randomized to surgery plus celiac plexus neurolysis with ethanol injection versus surgery plus placebo injection. Subjects will be followed every three months for survivorship or death to assess pain, quality of life measures, and narcotic pain control usage. The primary endpoint of pain control will be determined at one year post surgery. Subjects are not required to undergo any additional diagnostic testing procedures that are not part of their routine follow-up care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThis study will be offered to all patients scheduled to undergo open or laparoscopic operative resection of a presumed pancreatic (any location; i.e., head, body, or tail) or distal biliary tract cancer.\n\n* Physiologic suitability for major abdominal surgery\n* Aged 18 years and older\n* Written informed consent\n* Ability to understand and comply with study guidelines.\n\nExclusion Criteria:\n\n* Pregnancy\n* Previous, preoperative celiac nerve block\n* Neoadjuvant chemotherapy or radiation therapy\n* Incomplete tumor resection (R2 resection, grossly positive resection margin)\n* Presumed ampullary or duodenal cancer based on preoperative work-up or intraoperative findings\n* Benign tumors, neuroendocrine tumors, soft tissue tumors based on preoperative work-up or intraoperative findings\n* Known metastatic disease'}, 'identificationModule': {'nctId': 'NCT02002806', 'briefTitle': 'Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'A Randomized Controlled Trial of Intraoperative Chemical Splanchnicectomy for Patients With Resected Pancreatobiliary Malignancies', 'orgStudyIdInfo': {'id': '1011003552'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alcohol Injection', 'description': 'Celiac plexus neurolysis by alcohol injection One time administration during surgery 20 ml of alcohol injection on each side of aorta at level of celiac axis', 'interventionNames': ['Other: Alcohol Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Injection', 'description': 'Celiac plexus injection - placebo injection', 'interventionNames': ['Other: Placebo Injection']}], 'interventions': [{'name': 'Alcohol Injection', 'type': 'OTHER', 'otherNames': ['Ethanol Injection'], 'description': 'Celiac plexus neurolysis by alcohol injection', 'armGroupLabels': ['Alcohol Injection']}, {'name': 'Placebo Injection', 'type': 'OTHER', 'otherNames': ['Normal saline injection'], 'armGroupLabels': ['Placebo Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Michael G House, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University, Department of Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Surgery', 'investigatorFullName': 'Michael G. House', 'investigatorAffiliation': 'Indiana University'}}}}