Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-02-11 @ 2:01 PM
Study NCT ID:
NCT02421432
Status:
UNKNOWN
Last Update Posted:
2021-09-10
First Post:
2015-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and the Efficacy of Transanal TME in Difficult Cases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-02', 'studyFirstSubmitDate': '2015-04-05', 'studyFirstSubmitQcDate': '2015-04-15', 'lastUpdatePostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '2-year local recurrence free survival', 'timeFrame': '2 years after surgery'}, {'measure': '5-year overall survival', 'timeFrame': '5 years after surgery'}], 'primaryOutcomes': [{'measure': 'TME quality & circumferential resection margin (CRM)', 'timeFrame': 'the day of surgery', 'description': 'The quality of the mesorectum was determined using pathology reports and scored using three grades:\n\n* Complete: intact mesorectum with only minor irregularities of a smooth mesorectal surface. No defect is deeper than 5 mm, and there is no coning toward the distal margin of the specimen. There is a smooth circumferential resection margin on slicing.\n* Nearly complete: moderate bulk to the mesorectum, but irregularity of the mesorectal surface. Moderate coning of the specimen is allowed. At no site is the muscularis propria visible, with the exception of the insertion of the levator muscles.\n* Incomplete: little bulk to mesorectum with defects down onto muscularis propria and/or very irregular circumferential resection margin.'}], 'secondaryOutcomes': [{'measure': '30-day postoperative complications', 'timeFrame': '1 month after surgery', 'description': 'The Clavien-Dindo Classification of Surgical Complications. Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.\n\nGrade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications.\n\nGrade III: : Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management.\n\nGrade V: Death of a patient'}, {'measure': 'Number of harvested Lymph Nodes', 'timeFrame': 'the day of surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['trananal TME', 'safety', 'efficacy', 'difficult cases'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision in difficult case.\n\nDifficult case is defined as below;\n\n\\- If any one of the following (1 or 2 or 3)\n\n1. BMI: 30 or more\n2. Tumor size: more than 7cm in long diameter\n3. CRM: mesorectal fascia involvement or less than 1 mm on MRI', 'detailedDescription': 'Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 20-80 years\n* biopsy-proven adenocarcinoma of the rectum\n* clinical staging (c or yc): T0-3, N0-2, M0\n* Rectal cancer located 3-12 cm from the anal verge\n* ECOG performance status: 2 or less\n* If any one of the following (1 or 2 or 3)\n\n 1. BMI: 30 or more\n 2. Tumor size: more than 7cm in long diameter\n 3. CRM: mesorectal fascia involvement or less than 1 mm on MRI\n\nExclusion Criteria:\n\n* Synchronous colon cancer or other malignancy\n* Obstructing rectal cancer\n* Pregnant or breast-feeding\n* Receiving any other study agents\n* Fecal incontinence\n* History of prior colorectal cancer or inflammatory bowel disease'}, 'identificationModule': {'nctId': 'NCT02421432', 'briefTitle': 'Evaluation of the Safety and the Efficacy of Transanal TME in Difficult Cases', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision in Difficult Cases of Laparoscopic Surgery for Rectal Cancer', 'orgStudyIdInfo': {'id': 'NCC2015-0050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transanal total mesorectal excision', 'description': 'Laparoscopy-assisted transanal total mesorectal excision', 'interventionNames': ['Procedure: Transanal total mesorectal excision']}], 'interventions': [{'name': 'Transanal total mesorectal excision', 'type': 'PROCEDURE', 'description': 'Laparoscopy-assisted transanal total mesorectal excision', 'armGroupLabels': ['Transanal total mesorectal excision']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-769', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'overallOfficials': [{'name': 'Dae Kyung Sohn, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea: National Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD., PHD.', 'investigatorFullName': 'Dae Kyung Sohn', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}