Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-27 @ 11:53 PM
Study NCT ID:
NCT04951804
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2021-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EUS-CPN With and Without Bupivacaine
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': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-06-28', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Likert pain scores', 'timeFrame': 'Day 0 and Day 30', 'description': 'Pain scale used : 7-point Likert scale for pain (minimum value is 0, maximum value is 6; higher scores mean a worse outcome)'}], 'secondaryOutcomes': [{'measure': 'Difference in pain scores at T0 vs all other follow-up time points', 'timeFrame': 'Days 0, 3, 7, 30, 60, 90, 120', 'description': 'The 7-point Likert scale for pain (minimum value is 0, maximum value is 6; higher scores mean a worse outcome)'}, {'measure': 'Time to discharge from the endoscopy unit', 'timeFrame': 'From time of arrival in the recovery room after the intervention to time of discharge from the recovery room. The estimated period of time over which the event is assessed is up to two hours', 'description': 'Time spent in the recovery room following the procedure'}, {'measure': 'Narcotic usage', 'timeFrame': 'Narcotic usage for the 3 day-period preceding Days 0, 60 and 120', 'description': 'Change in cumulative narcotic usage between Day 0 and Day 60, and between Day 0 and Day 120'}, {'measure': 'Adverse events', 'timeFrame': 'Days 0, 3, 7, 30, 60, 90, 120', 'description': 'Rate of all intervention-specific adverse events (Using the American Society of Gastrointestinal Endoscopy classification)'}, {'measure': 'Survival', 'timeFrame': 'Up to 18 months', 'description': 'Number of days between the EUS-CPN intervention and death'}, {'measure': 'Difference in Global Rating Scale of Change at T3 vs all other follow-up time points', 'timeFrame': 'Days 3, 7, 30, 60, 90, 120', 'description': "The Global Rating Scale of Change will be used to measure subjects' impression of improvement in their health condition after T0 (the day celiac plexus neurolysis is performed) (minimum value is 0, maximum value is 6; higher scores mean a better outcome)"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic Cancer', 'Celiac plexus neurolysis', 'Bupivacaine', 'Endoscopic ultrasound', 'With Bupivacaine', 'Without Bupivacaine'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '37684697', 'type': 'DERIVED', 'citation': 'Esmail E, Paquin SC, Sahai AV. Protocol for a randomized controlled trial of endoscopic ultrasound guided celiac plexus neurolysis (EUS-CPN) with vs without bupivacaine. Trials. 2023 Sep 8;24(1):576. doi: 10.1186/s13063-023-07487-7.'}]}, 'descriptionModule': {'briefSummary': 'Endoscopic ultrasound (EUS) allows EUS-guided trans gastric injection of absolute alcohol around the base of the celiac plexus (celiac plexus neurolysis (EUS-CPN)), to help alleviate pain associated with pancreatic cancer.\n\nIt is standard procedure to inject bupivacaine immediately before injecting absolute alcohol, to theoretically prevent pain that may occur during and after the procedure. However, there are no data showing whether bupivacaine injection has any real influence on intra-procedural, immediate post-procedural, or long-term pain control. The injection of bupivacaine before the alcohol may have no effect, a synergistic effect, or an antagonistic effect, by diluting the alcohol, and reducing its neurolytic capacity. Inadvertent intravascular injection of bupivacaine may also cause irreversible cardiac arrhythmias and death.\n\nThe investigators therefore propose a randomized clinical trial to determine whether the exclusion of bupivacaine during EUS-guided CPN improves outcomes, or not.', 'detailedDescription': 'Pancreatic malignancies are the second most frequent gastrointestinal malignancy in Canada. From cancer mortality statistics in 2014, there were 4,700 new cases of pancreatic malignancies second only to colorectal cancer, representing 2.4% of all cancers. Even with chemotherapy, the median survival for patients with pancreatic adenocarcinoma is 6 to 10 months. Few patients are diagnosed at a resectable stage (12%-20%) so many patients are candidates for palliation only.\n\nIn this context, one of the most important symptoms is pain because it often affects both quality of life and survival. 70 to 80 % of patients with pancreatic cancer have abdominal pain at the time of diagnosis. Adequate pain control is therefore an essential component of care in these patients. In the initial phase, the pain is visceral, but with disease progression, somatic pain may occur, especially due to the peri-pancreatic invasion of neural structures, such as the celiac plexus.\n\nStandard analgesics such as acetaminophen are usually ineffective and the use and effectiveness of opioids is frequently limited by side effects such as nausea, constipation, somnolence, confusion or respiratory depression.\n\nThe celiac plexus is immediately adjacent to the gastric wall. Endoscopic ultrasound (EUS) allows EUS-guided trans gastric injection of neurolytic agents around the celiac plexus (celiac plexus neurolysis \\[CPN\\]). Under conscious sedation, the echoendoscope is advanced into the stomach, just distal to the gastro-esophageal junction. The region of the celiac plexus is identified around the takeoff of the celiac artery from the aorta. Then, under real-time ultrasound guidance, a 19g needle is used to inject a neurolytic agent such as absolute alcohol around the base of the celiac artery. The entire procedure takes approximately 5 minutes. Absolute alcohol causes the immediate destruction of the celiac plexus neurons, by precipitation of endoneural lipoproteins and mucoproteins.\n\nThe effectiveness of CPN, is well established. It is safe, produces significant pain reduction, significantly reduces narcotic requirements, and may even increase survival. The investigators were the first to publish a randomized, sham-controlled trial demonstrating the efficacy of EUS-CPN for pain due to pancreatic cancer, and authored the most recent published guidelines on the use of EUS-CPN.\n\nBased on our experience in over 1000 neurolysis procedures, patients undergoing EUS-guided CPN may experience pain, acutely during alcohol injection, and sometimes post-procedure, for up to a few hours. (Unpublished observations) It is possible that the presence of pain during injection of alcohol indicates that the celiac plexus has been accurately targeted and may therefore portend better long-term pain control.\n\nCurrently, during the neurolysis procedure, it is standard procedure to inject bupivacaine immediately before injecting absolute alcohol, to theoretically prevent pain during and after the procedure.\n\nThe true value of bupivacaine during neurolysis has never been studied. There are no data showing whether bupivacaine injection has any real influence on intra-procedural, immediate post-procedural, or long-term pain control. The injection of bupivacaine before the alcohol may have no effect, a synergistic effect, or an antagonistic effect, by diluting the alcohol, and reducing its neurolytic capacity. Inadvertent intravascular injection of bupivacaine may also cause irreversible cardiac arrhythmias and death.\n\nIn other words, in the worst case scenario, the injection of bupivacaine may increase procedural risk, without any associated benefit in terms of pain reduction.\n\nThe EUS team at the CHUM stopped using bupivacaine during neurolysis approximately 2 years ago and has noticed no obvious difference in pain during the procedure or in the immediate post-procedure recovery period, no increase in complications, and a possible reduction in requests for repeat neurolysis - suggesting that neurolysis without bupivacaine may be more effective. (Unpublished observations)\n\nThe investigators therefore propose a randomized clinical trial to determine whether the exclusion of bupivacaine during EUS-guided CPN improves outcomes, or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Malignant-appearing pancreatic mass, or proven pancreatic cancer involving the pancreatic genu, body, or tail\n2. Any level of abdominal or back pain considered to be potentially related to the mass:\n\n 1. New onset pain (\\<3 months)\n 2. Constant\n 3. Centrally located\n 4. With or without irradiation to the back\n 5. No obvious other source of pain based on history and physical examination by the attending endosonographer\n3. No possibility of surgical management\n4. Signed, informed consent\n5. Celiac axis accessible for bilateral neurolysis at EUS.\n\nExclusion Criteria:\n\n1\\. Allergy to bupivacaine'}, 'identificationModule': {'nctId': 'NCT04951804', 'acronym': 'EUS-NB', 'briefTitle': 'EUS-CPN With and Without Bupivacaine', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'A Randomized Controlled Trial of Endoscopic Ultrasound Guided Celiac Plexus Neurolysis (EUS-CPN) With and Without Bupivacaine', 'orgStudyIdInfo': {'id': '21.151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EUS-CPN with bupivacaine', 'description': 'Endoscopic ultrasound guided celiac plexus neurolysis with absolute alcohol 20 mL preceded by injection of 10 ml of bupivacaine 0.5%.', 'interventionNames': ['Procedure: EUS-CPN with bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'EUS-CPN without bupivacaine', 'description': 'Endoscopic ultrasound guided celiac plexus neurolysis with absolute alcohol 20 mL only.', 'interventionNames': ['Procedure: EUS-CPN without bupivacaine']}], 'interventions': [{'name': 'EUS-CPN without bupivacaine', 'type': 'PROCEDURE', 'description': 'Under conscious sedation, an echoendoscope is advanced into the stomach, just distal to the gastro-esophageal junction. The region of the celiac plexus is identified around the takeoff of the celiac artery from the aorta. Then, under real-time ultrasound guidance, a 19g needle is used to inject a neurolytic agent such as absolute alcohol around the base of the celiac artery.', 'armGroupLabels': ['EUS-CPN without bupivacaine']}, {'name': 'EUS-CPN with bupivacaine', 'type': 'PROCEDURE', 'description': 'Under conscious sedation, an echoendoscope is advanced into the stomach, just distal to the gastro-esophageal junction. The region of the celiac plexus is identified around the takeoff of the celiac artery from the aorta. Then, under real-time ultrasound guidance, a 19g needle is used to firstly inject bupivacaine and secondly a neurolytic agent such as absolute alcohol around the base of the celiac artery.', 'armGroupLabels': ['EUS-CPN with bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'CHARLES MACKAY, RN', 'role': 'CONTACT', 'email': 'charles.mackay.chum@ssss.gouv.qc.ca', 'phone': '514-890-8000', 'phoneExt': '36484'}, {'name': 'Anand V Sahai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sarto Paquin, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Centre de recherche du Centre hospitalier de l'Université de Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'CHARLES MACKAY, RN', 'role': 'CONTACT', 'email': 'charles.mackay.chum@ssss.gouv.qc.ca', 'phone': '514-890-8000', 'phoneExt': '36484'}], 'overallOfficials': [{'name': 'ANAND V SAHAI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre de Recherche du Centre Hospitalier de l'Université de Montréal"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}