Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-01-01 @ 2:51 PM
Study NCT ID:
NCT05517369
Status:
WITHDRAWN
Last Update Posted:
2023-08-22
First Post:
2022-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Hybrid-ESD+ and LiftUp® on the en Bloc/R0 Rate in Colorectal Adenomas Between 2 and 3 cm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants fitting into the study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-17', 'studyFirstSubmitDate': '2022-08-12', 'studyFirstSubmitQcDate': '2022-08-23', 'lastUpdatePostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'R0 resection rate of non pedunculated colorectal polyps between 2 and 3cm using hybrid ESD+', 'timeFrame': 'after 14 days', 'description': 'In how many cases a complete R0 resection (basal and lateral margin) is found on pathologic examination'}], 'secondaryOutcomes': [{'measure': 'Complication rate (perforations, bleeding)', 'timeFrame': 'up to 4 weeks', 'description': 'Perforation: dehiscence of the muscularis propria diagnosed during or after resection.\n\nHemorrhage:\n\n* Clinically significant post-endoscopic bleeding (CSPEB). Bleeding from the ablation site with hematochezia after completion of index colonoscopy\n* Intraprocedural bleeding (IPB). Percent, defined as bleeding lasting \\> 60 seconds during intervention necessitating therapy'}, {'measure': 'Recurrence rate', 'timeFrame': '6 months', 'description': 'Rate of adenoma residue and/or adenoma recurrence in percent after 6 months. This is determined by the colonoscopic and histologic findings from 2 biopsies from the scar or resection specimen.'}, {'measure': 'Procedural parameters - Intervention duration', 'timeFrame': '1 day', 'description': 'Intervention duration (time range from injection to complete resection)'}, {'measure': 'Procedural parameters - Cleanliness of the colon', 'timeFrame': '1 day', 'description': 'Cleanliness of the colon (according to the Boston Bowel Preparation Scale (BBPS) 0-9)'}, {'measure': 'Localization of polyp', 'timeFrame': '1 day', 'description': 'Position of the polyp within the colon (Coecum, Ascendens, Transversum, Deschendens, Sigmoid, Rectum)'}, {'measure': 'Polyp size', 'timeFrame': '1 day', 'description': 'Polyp diameter in mm'}, {'measure': 'Polyp morphology', 'timeFrame': '1 day', 'description': 'according to paris classification'}, {'measure': 'Polyp histology', 'timeFrame': '7 days', 'description': 'histological examination (tubular, tubulovillous, villous)'}, {'measure': 'Duration of hospital stay', 'timeFrame': 'up to 4 weeks', 'description': 'Time frame from first day to discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hybrid-ESD+', 'Endoscopic Resection'], 'conditions': ['Colorectal Adenoma']}, 'descriptionModule': {'briefSummary': 'This study examines whether the use of Hybrid-ESD+ with LiftUp (Injection solution) results in a higher en bloc and/or R0 rate for non pedunculated colorectal adenomas between 2 and 3 cm than described in the literature for conventional EMR.', 'detailedDescription': 'There are several options for endoscopic polypectomy of polyps between 2-3 cm, all of which have their advantages and disadvantages and none of which has yet become the established standard procedure.\n\nConventional EMR has the disadvantage of more frequent residuals and/or recurrences due to lack of en bloc resection, while ESD has the disadvantage of being more complex and complications more likely.\n\nA possible alternative is the use of hybrid ESD+ with LiftUp subcutaneous injection. The method with the LiftUp gel forming a stable gel cushion under the lesion, in combination with the circular circumcision of the mucosa at this site and the AWC for the current loop and the grasper, could achieve a better en bloc resection rate with a low complication rate than other procedures mentioned above.\n\nThe higher effectiveness in terms of recurrences and complications could subsequently result in a reduction of endoscopic or surgical re-interventions.\n\nIn this study, non-pedunculated colorectal polyps between 2 and 3cm in size are resected using ESD+ method and lift up as an injection solution.\n\nMethodological and clinical parameters are recorded. After 4 weeks, the patients are contacted by telephone to record possible late effects.\n\nIf an endoscopic control is performed after 6 months (according to the guideline or according to the investigator), the findings are also recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-pedunculated lesion in the colorectum (epithelial lesion, 2-3 cm).\n* Ablation medically indicated and possible (coagulation, etc. - as determined by the center)\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Pedunculated lesion (Paris0-Ip)\n* Size of the lesion \\<2cm or \\>3cm\n* Pregnant and breastfeeding women\n* Patient not capable of informed consent / consent not possible\n* Bioptic evidence of a carcinoma / high probability of the presence of a carcinoma\n* Non-lifting sign / known recurrence after previous therapy\n* Impassable stenosis in the colon / rectum\n* Patients with compelling need for therapeutic anticoagulation or dual antiplatelet therapy that cannot be discontinued for resection\n* As per contraindications from the AWC \\& LiftUp Instructions for Use:\n* The AWC is not to be used if flexible-endoscopic procedures are contraindicated.\n* The LiftUp gel should not be used when flexible endoscopic procedures are contraindicated, especially in combination with submucosal endoscopic resection (EMR) or endoscopic submucosal dissection (ESD) injectables.\n* LiftUp gel should not be used in patients with known sensitivity to any of the ingredients.'}, 'identificationModule': {'nctId': 'NCT05517369', 'acronym': 'HADRIAN', 'briefTitle': 'Impact of Hybrid-ESD+ and LiftUp® on the en Bloc/R0 Rate in Colorectal Adenomas Between 2 and 3 cm', 'organization': {'class': 'OTHER', 'fullName': 'Wuerzburg University Hospital'}, 'officialTitle': 'Impact of Using Hybrid-ESD+ and LiftUp® as Injectable on en Bloc/R0 Rate in Colorectal Adenomas Between 2 and 3 cm.', 'orgStudyIdInfo': {'id': 'Brand_HADRIAN_10_08_2022'}, 'secondaryIdInfos': [{'id': 'WHO Universal Trail Number', 'type': 'OTHER', 'domain': 'U1111-1281-5357'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hybrid-ESD+', 'description': 'All participants receive resection of non-pedunculated colorectal polyp between 2 and 3 cm using the Hybrid-ESD+ method.', 'interventionNames': ['Procedure: Hybrid ESD+']}], 'interventions': [{'name': 'Hybrid ESD+', 'type': 'PROCEDURE', 'description': 'Injection of the Lift Up solution, followed by circumcision of the lesion using a snare tip or ESD knife. Using an additional working channel (AWC), the lesion is resected using a grasper and snare.', 'armGroupLabels': ['Hybrid-ESD+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32052', 'city': 'Herford', 'country': 'Germany', 'facility': 'Mathilden Hospital Herford', 'geoPoint': {'lat': 52.11457, 'lon': 8.67343}}, {'zip': '34119', 'city': 'Kassel', 'country': 'Germany', 'facility': 'Agaplesion Diakonie Kliniken Kassel', 'geoPoint': {'lat': 51.31667, 'lon': 9.5}}, {'zip': '71640', 'city': 'Ludwigsburg', 'country': 'Germany', 'facility': 'Klinikum Ludwigsburg', 'geoPoint': {'lat': 48.89731, 'lon': 9.19161}}, {'zip': '48145', 'city': 'Münster', 'country': 'Germany', 'facility': 'St. Franziskus Hospital Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '71364', 'city': 'Winnenden', 'country': 'Germany', 'facility': 'Rems-Murr-Klinikum Winnenden', 'geoPoint': {'lat': 48.87563, 'lon': 9.39819}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universitätsklinik Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '8037', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Stadtspital Waid', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Waid City Hospital, Zurich', 'class': 'OTHER'}, {'name': 'University Hospital Ulm', 'class': 'OTHER'}, {'name': 'Rems-Murr-Klinikum Winnenden', 'class': 'UNKNOWN'}, {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, {'name': 'Klinikum Ludwigsburg', 'class': 'OTHER'}, {'name': 'Mathilden Hospital Herford', 'class': 'UNKNOWN'}, {'name': 'St. Franziskus Hospital Münster', 'class': 'UNKNOWN'}, {'name': 'Agaplesion Kliniken Kassel', 'class': 'UNKNOWN'}, {'name': 'Ovesco Endoscopy AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}