Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-02-18 @ 4:02 PM
Study NCT ID:
NCT00514332
Status:
TERMINATED
Last Update Posted:
2007-08-09
First Post:
2007-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Colorectal Stents and Primary Surgery in Obstructive Colonic Cancer. A Randomized, Controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic 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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015607', 'term': 'Stents'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'whyStopped': 'enrolling participants stopped', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-08-08', 'studyFirstSubmitDate': '2007-08-08', 'studyFirstSubmitQcDate': '2007-08-08', 'lastUpdatePostDateStruct': {'date': '2007-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of stoma in each group', 'timeFrame': 'within the first 6 month(plus or minus 1 month) after surgery'}], 'secondaryOutcomes': [{'measure': 'mortality in each group', 'timeFrame': 'within the first 6 month (plus or minus 1 month) after surgery'}, {'measure': 'complications', 'timeFrame': 'within the first 6 month (plus or minus 1 month) after surgery'}, {'measure': 'number of procedures', 'timeFrame': 'within the first 6 month (plus or minus 1 month) after surgery'}, {'measure': 'length of stay', 'timeFrame': 'within the first 6 month (plus or minus 1 month) after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colorectal stents', 'colonic obstruction', 'colonic adenocarcinoma', 'colorectal surgery'], 'conditions': ['Colorectal Obstruction', 'Left Colonic Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '21170659', 'type': 'DERIVED', 'citation': 'Pirlet IA, Slim K, Kwiatkowski F, Michot F, Millat BL. Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial. Surg Endosc. 2011 Jun;25(6):1814-21. doi: 10.1007/s00464-010-1471-6. Epub 2010 Dec 18.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate wether colorectal stenting carry a significant clinical advantage', 'detailedDescription': 'Randomized controlled comparison between stents and primary surgery in obstructive left colonic obstructive carcinoma outside palliative situations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obstructive stenosis due to left colorectal cancer\n\nExclusion Criteria:\n\n* previous colorectal cancer\n* other colorectal location'}, 'identificationModule': {'nctId': 'NCT00514332', 'briefTitle': 'Comparison Between Colorectal Stents and Primary Surgery in Obstructive Colonic Cancer. A Randomized, Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Etude Prospective Multicentrique randomisée Comparant Deux stratégies thérapeutiques Pour Les Cancers Coliques en Occlusion : stratégie Chirurgicale Exclusive Versus stratégie thérapeutique Avec Stent Colique Initial', 'orgStudyIdInfo': {'id': 'UF7683'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'primary surgery group', 'interventionNames': ['Procedure: stent']}], 'interventions': [{'name': 'stent', 'type': 'PROCEDURE', 'otherNames': ['self-expending metallic stents'], 'description': 'stent placement for colorectal cancer obstruction', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bertrand L MILLAT, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Rouen', 'class': 'OTHER'}, {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, {'name': 'Rennes University Hospital', 'class': 'OTHER'}, {'name': 'University Hospital, Lille', 'class': 'OTHER'}, {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}]}}}