Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-31 @ 5:20 AM
Study NCT ID:
NCT04825457
Status:
UNKNOWN
Last Update Posted:
2021-04-01
First Post:
2021-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Anchoring-tip vs. Conventional EMR of Colorectal Polyps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome was comparing the R0 resection rate between Anchoring-tip EMR and Conventional EMR.', 'timeFrame': 'From EMR to reporting of histopathology, 1 month', 'description': 'Histopathologic complete resection (R0) was defined as en bloc resection and clear lateral and vertical resection margins.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Polyp']}, 'descriptionModule': {'briefSummary': 'Endoscopic mucosal resection (EMR) is an effective and has been widely used technique for the treatment of superficial colorectal neoplasms. Although, conventional EMR (CEMR) showed high efficacy for the management of colorectal superficial neoplasms, there is problematic limitation in this technique - incomplete resection. In literature, the anchoring-tip EMR (AEMR), named as "Tip-in EMR" was first introduced in 2016 from Japan. Recently, several retrospective studies have been suggested about the effectiveness of AEMR. However, there has been no prospective randomized controlled study to identify its advantage over CEMR. Therefore, the investigators performed a multicenter randomized controlled trial to estimate the effectiveness of AEMR compared with CEMR for the endoscopic treatment of intermediate-size (10 to 20 mm) colorectal polyps.', 'detailedDescription': 'After injection of normal saline solution mix, snaring was tried for CEMR. In AEMR, the snare tip was projected from the sheath by 1-2 mm length. Consequently, a small mucosal incision was made at proximal side of lesion. Then the snare was deployed progressively and adjusted around the lesion trying to obtain free margins. At the final step of both conventional and Tip-in EMR, the lesion was resected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intermediate-size (10 to 20 mm) colorectal polyps\n* Morphologically sessile (Is), slightly elevated (IIa), flat (IIb), and slightly depressed (IIc) as Paris classification of superficial neoplastic lesions\n* Laterally spreading tumor (granular and nongranular type) as Kudo classification.\n\nExclusion Criteria:\n\n* Pedunculated or excavated/ulcerated polyps\n* Polyps with features strongly suggestive of submucosal invasive carcinoma\n* Polyps in patients with inflammatory bowel disease, familial polyposis, electrolyte abnormality, and coagulopathy\n* Residual lesions after endoscopic resection or presence of severe submucosal fibrosis.'}, 'identificationModule': {'nctId': 'NCT04825457', 'briefTitle': 'Comparative Study of Anchoring-tip vs. Conventional EMR of Colorectal Polyps', 'organization': {'class': 'OTHER', 'fullName': 'Kyungpook National University Chilgok Hospital'}, 'officialTitle': 'Comparative Study of Anchoring-tip vs. Conventional EMR of Intermediate-Size Colorectal Polyps: Multi-center, Prospective, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2020-10-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Anchoring-tip EMR', 'description': 'AEMR, the snare tip was projected from the sheath by 1-2 mm length. Consequently, a small mucosal incision was made at proximal side of lesion. Then the snare was deployed progressively and adjusted around the lesion trying to obtain free margins.', 'interventionNames': ['Procedure: Anchoring-tip vs. Conventional']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional EMR', 'description': 'After injection of normal saline solution mix, snaring was tried for CEMR.', 'interventionNames': ['Procedure: Anchoring-tip vs. Conventional']}], 'interventions': [{'name': 'Anchoring-tip vs. Conventional', 'type': 'PROCEDURE', 'description': 'Anchoring-tip: the snare tip was projected from the sheath by 1-2 mm length. Consequently, a small mucosal incision was made at proximal side of lesion. Then the snare was deployed progressively and adjusted around the lesion trying to obtain free margins. At the final step of both conventional and Tip-in EMR, the lesion was resected.\n\nConventional: After injection of normal saline solution mix, snaring was tried for polyp resection.', 'armGroupLabels': ['Anchoring-tip EMR', 'Conventional EMR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41404', 'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joon Seop Lee, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'coolsmurf@naver.com', 'phone': '+82-53-200-3084'}], 'facility': 'Joon Seop Lee', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'centralContacts': [{'name': 'Joon Seop Lee, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'coolsmurf@naver.com', 'phone': '+82-53-200-3084'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyungpook National University Chilgok Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Joon Seop Lee', 'investigatorAffiliation': 'Kyungpook National University Chilgok Hospital'}}}}