Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:50 AM
Study NCT ID:
NCT05736705
Status:
WITHDRAWN
Last Update Posted:
2024-06-27
First Post:
2023-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monopolar and Bipolar in Esophageal ESD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069916', 'term': 'Endoscopic Mucosal Resection'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The patient will not know which electrocautery tool will be used in their procedure.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups with patients randomized into receiving either the standard of care monopolar electrocautery tool or bipolar electrocautery tool.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study being withdrawn as it is re-written now as a prospective study. Please reference new study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2023-02-13', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speed of Endoscopic Submucosal Dissection', 'timeFrame': 'Day 1 (procedure day)', 'description': 'The speed of endoscopic submucosal dissection as calculated by cm2/hour'}], 'secondaryOutcomes': [{'measure': 'En-bloc resection achieved', 'timeFrame': 'Day 1 (procedure day)', 'description': 'Endoscopist removal of entire tissue specimen as a whole'}, {'measure': 'R0 Resection achieved', 'timeFrame': '1-3 days post-procedure', 'description': 'Margins of tissue specimen deemed by pathologist as completely excised (R0)'}, {'measure': 'Curative Resection achieved', 'timeFrame': '1-3 days post-procedure', 'description': 'Complete removal of diseased tissue by endoscopic submucosal dissection procedure'}, {'measure': 'Adverse events', 'timeFrame': '1 month, 3 months, 6 months, 12 months', 'description': 'Collection of unanticipated medical occurrences within a 12 month time frame'}, {'measure': 'Rate of esophageal stricturing post-procedure', 'timeFrame': '1-3 days post-procedure', 'description': 'Calculated as a percentage of patients reported with stricturing with 1-3 days following procedure.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Esophageal Neoplasm', 'Esophageal Polyp', 'Endoscopic Submucosal Dissection', 'Bipolar Electocautery']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to prospectively document the efficacy and clinical outcomes of Endoscopic Submucosal Dissection procedure that utilize either a novel Bipolar-Current ESD device or the standard monopolar electrocautery knife.', 'detailedDescription': "Endoscopic submucosal dissection (ESD) is a novel technique for the removal of esophageal lesions or polyps with high-risk features. ESD is minimally invasive and allows the removal of esophageal polyps without resorting to morbid surgery. The process of ESD includes marking the lesions selected for removal, followed by submucosal injection of a lifting agent, then circumferential incisions using a specialized knife followed by submucosal dissection of the entire lesion.\n\nTraditionally, knifes utilizing monopolar current such as dual knife or hybrid knife were the preferred tools for endoscopic submucosal dissection. These knifes allows accurate dissection and excellent hemostasis. However, due to monopolar current generated heat, post coagulation syndrome can be seen in up to 8 to 40 % of patients. Post coagulation syndrome present with pain, fever and leukocytosis and requires supportive treatment with IV fluid and antibiotics. In addition, for large esophageal lesions, stricturing can occur after resection due to significant scar formation induced by large amounts of energy. Almost all patients with 60% of the esophageal circumference removed via monopolar knives, will develop an esophageal stricture at some point. These patients require serial esophageal dilations, and although easily managed, its development can be quite troublesome to the patient. Nevertheless, ESD is still the preferred modality for removal of these lesions, since it avoids the need for morbid surgery. Recently, a novel bipolar RFA knife were approved by FDA for the performance of ESD. The knife utilizes bipolar RFA current for submucosal dissection which can potentially expedite submucosal dissection and decrease the rates of post polypectomy syndrome and scar formation, by using significantly less energy. This bipolar knife may allow for removal of large esophageal lesions without causing major esophageal stricturing.\n\nOur tertiary referral center Baylor St Luke's Medical Center is a center of excellence for ESD procedure and the investigators have previously reported our Esophageal ESD experience using the monopolar current knife. The goal of our protocol is to compare the performance of monopolar current cutting knife and bipolar RFA knife in esophageal endoscopic submucosal dissection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is ≥ 18 years old\n* Patient is capable of providing informed consent\n* Patient is referred for ESD procedure of an esophageal neoplastic lesion\n\nExclusion Criteria:\n\n* Patient is \\< 18 years old\n* Patient refused and/or unable to provide consent\n* Patient is a pregnant woman\n* Patients with lesions removed with other techniques besides ESD (i.e. cap EMR) or a modified ESD technique'}, 'identificationModule': {'nctId': 'NCT05736705', 'briefTitle': 'Monopolar and Bipolar in Esophageal ESD', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Randomized Controlled Trial Comparing Outcomes of Monopolar Current Cutting Knife and Bipolar RFA Knife in Esophageal Endoscopic Submucosal Dissection', 'orgStudyIdInfo': {'id': 'H-52921'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Monopolar Electrocautery tool', 'description': 'Patients randomized into this group will receive the standard of care monopolar tool for their endoscopic submucosal dissection procedure.', 'interventionNames': ['Procedure: Endoscopic Submucosal Dissection']}, {'type': 'EXPERIMENTAL', 'label': 'Bipolar Electrocautery tool', 'description': 'Patients randomized into this group will receive the standard of care bipolar tool for their endoscopic submucosal dissection procedure.', 'interventionNames': ['Procedure: Endoscopic Submucosal Dissection', 'Device: Bipolar electrocautery knife']}], 'interventions': [{'name': 'Endoscopic Submucosal Dissection', 'type': 'PROCEDURE', 'otherNames': ['ESD', 'Mucosal Resection'], 'description': 'Participants randomized in this arm will have the removal of their esophageal lesion utilizing the monopolar electrocautery knife.', 'armGroupLabels': ['Bipolar Electrocautery tool', 'Monopolar Electrocautery tool']}, {'name': 'Bipolar electrocautery knife', 'type': 'DEVICE', 'otherNames': ['ESD', 'Mucosal Resection'], 'description': 'Participants randomized in this arm will have the removal of their esophageal lesion utilizing the bipolar electrocautery knife.', 'armGroupLabels': ['Bipolar Electrocautery tool']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Salmaan Azam Jawaid, MD', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}