Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT05121805
Status:
UNKNOWN
Last Update Posted:
2023-12-26
First Post:
2021-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recurrences After Standard EMR vs Plus Thermal Ablation EMR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}, {'id': 'D009364', 'term': 'Neoplasm Recurrence, Local'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 306}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-19', 'studyFirstSubmitDate': '2021-11-04', 'studyFirstSubmitQcDate': '2021-11-04', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence', 'timeFrame': '6 months', 'description': 'Adenoma recurrence at resection site'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Snare tip soft coagulation', 'EMR'], 'conditions': ['Polyps of Colon', 'Recurrence, Local Neoplasm']}, 'referencesModule': {'references': [{'pmid': '38368409', 'type': 'DERIVED', 'citation': 'Kemper G, Gerges C, Schoon EJ, Schreuder RM, Schrauwen RRW, Epping LSM, Beyna T, Drenth JPH, Gundug U, Siersema PD, van Geenen EJM; ENDOCARE study group. Recurrences of advanced sessile and lateral spreading colorectal adenoma after endoscopic mucosal resection (EMR) thermal ablation versus no adjuvant therapy (RESPECT): a protocol of an international randomized controlled trial. Trials. 2024 Feb 17;25(1):132. doi: 10.1186/s13063-024-07915-2.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to investigate whether thermal ablation EMR with soft tip snare coagulation (STSC) reduces the recurrence rate of lateral spreading or sessile polyps ≥20mm compared to standard EMR.', 'detailedDescription': 'Rationale:\n\nLowering the EMR recurrence rate will potentially lead to fewer colonoscopies resulting in less additional costs, less compliance burdens and less exposure to possible procedure related risks.\n\nObjective:\n\nTo investigate whether thermal ablation EMR with snare tip soft coagulation (STSC) reduces the recurrence rate of lateral spreading or sessile polyps ≥20mm compared to standard EMR.\n\nStudy design:\n\nThis study entails a patient-blinded multicenter prospective randomized controlled trial that will be conducted between January 2022 and May 2025 in 1 academic and 7 non-academic hospitals in The Netherlands and it will take place in the outpatient clinics of the participating centers.\n\nStudy population:\n\nAll patients aged ≥ 18 years with proven colorectal sessile of lateral spreading polyps (Paris classification 0-IIa/b/c, Is) with a diameter of ≥ 20mm requiring piecemeal resection with EMR are eligible for inclusion.\n\nIntervention:\n\nSnare tip soft coagulation of the entire EMR margin is a technique for the removal of potential residual adenoma.\n\nMain study endpoint:\n\nPolyp recurrence after 6 months follow up. Recurrence is evaluated histologically and endoscopically with biopsies taken during follow up colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Proven colorectal sessile or lateral spreading polyps with a diameter of ≥ 20mm requiring piecemeal resection with EMR.\n\nExclusion Criteria:\n\n* Previously attempted intervention\n* Polyps with any signs of invasive malignancy\n* Presence or suspicion of inflammatory bowel disease\n* En bloc resection\n* Incomplete resection'}, 'identificationModule': {'nctId': 'NCT05121805', 'acronym': 'RESPECT', 'briefTitle': 'Recurrences After Standard EMR vs Plus Thermal Ablation EMR', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Recurrences After Standard EMR vs Plus Thermal Ablation EMR of Advanced Sessile and Lateral Spreading Colorectal Adenoma', 'orgStudyIdInfo': {'id': 'NL7463209120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EMR plus snare tip soft coagulation', 'description': 'Post procedural prophylactic coagulation of the entire margin of the resection site creating a 2-3mm rim.', 'interventionNames': ['Procedure: Snare tip soft coagulation']}, {'type': 'NO_INTERVENTION', 'label': 'Standard EMR', 'description': 'No prophylactic coagulation'}], 'interventions': [{'name': 'Snare tip soft coagulation', 'type': 'PROCEDURE', 'description': 'Thermal ablation of the entire resection margin', 'armGroupLabels': ['EMR plus snare tip soft coagulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Gijs Kemper', 'role': 'CONTACT'}], 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'centralContacts': [{'name': 'Gijs Kemper, MD', 'role': 'CONTACT', 'email': 'gijs.kemper@radboudumc.nl', 'phone': '31 614945308'}], 'overallOfficials': [{'name': 'Peter Siersema', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no particular plan. But the investigators are willing to share the data with colleagues depending which research question they want to answer.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maas Hospital Pantein', 'class': 'OTHER'}, {'name': 'Evangelisches Krankenhaus Düsseldorf', 'class': 'OTHER'}, {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, {'name': 'Bernhoven Hospital', 'class': 'OTHER'}, {'name': 'Maasstad Hospital', 'class': 'OTHER'}, {'name': 'St Jansdal Hospital', 'class': 'OTHER'}, {'name': 'Bravis Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}