Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-03-10 @ 8:06 PM
Study NCT ID:
NCT01565993
Status:
TERMINATED
Last Update Posted:
2012-05-25
First Post:
2012-03-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elviramquintanilla@hotmail.com', 'phone': '34 914818000', 'title': 'Dra Elvira Quintanilla', 'phoneExt': '8326', 'organization': 'Hospital Universitario Severo Ochoa'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Not to reach the sample size established previously in the initial design, implies bias and decreases the strength of the study.'}}, 'adverseEventsModule': {'timeFrame': 'During the endoscopic procedure', 'eventGroups': [{'id': 'EG000', 'title': 'Group A: Hemoclips', 'description': 'In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop', 'otherNumAtRisk': 66, 'otherNumAffected': 3, 'seriousNumAtRisk': 66, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Group B: Conventional Polipectomy', 'description': 'In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique', 'otherNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mucosal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Mucosal burn'}], 'seriousEvents': [{'term': 'Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Perforation'}], 'frequencyThreshold': '4.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Polyps With Complications After Polypectomy (The Total Complication Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'units': 'Polyps', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemoclip', 'description': 'In group HEMOCLIP, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop. In all the polypectomies that were assigned to group HEMOCLIP, a rotatable clip-fixing device "Quickclip 2" standard was used (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan), with an opening diameter of 135º and a maximum insertion portion diameter of 2.6 mm'}, {'id': 'OG001', 'title': 'Conventional Polipectomy', 'description': 'In group CONVENTIONAL POLYPECTOMY, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique.Disposable electrosurgical snares (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan) and an electrosurgery unit ERBE (ERBE Elektromedizin GmbH, Germany) were used for polyp resection.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding', 'description': 'In order to test the ability of prophylactic hemoclipping to prevent post-polypectomy bleeding, the investigators were required to register all the adverse events that occurred. These adverse events were called "complications", despite their severity and clinical significance', 'unitOfMeasure': 'polyps', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Polyps', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Based on an anticipated decrease of at least 12% in the rate of adverse bleeding events between the group A and the group B, there was an alpha error of 0.05 and a statistical power of 80% with a patient inclusion rate of 1:1. The number of polyps required is 146 per group. Using the Fleiss correction, the final number is 164 per group.'}, {'type': 'SECONDARY', 'title': 'Difficult to Place the Clip', 'timeFrame': 'During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted)', 'description': 'The hemoclips which were incorrectly placed, mainly because the pedicles were very thick and/or short.', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A: Hemoclips', 'description': 'In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop'}, {'id': 'FG001', 'title': 'Group B: Conventional Polipectomy', 'description': 'In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'comment': '3 patients were excluded for failing to meet the inclusion criteria', 'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'A total of 105 polypectomies were performed on 98 patients', 'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'From 2007 to 2010, the patients were selected at the digestive endoscopy unit.All of the consecutive patients referred for colonoscopy to the endoscopy office were informed of the aims of the ongoing research and were invited to take part in the study for which they gave their informed consent before the endoscopic procedure was performed', 'preAssignmentDetails': 'Where more than one polyp was observed in a patient, all the polyps were included in the same randomization group, so that they all underwent the same technique (conventional or modified polypectomy). 3 patients were excluded for failing to meet the inclusion criteria since they involved semi-pedunculated polyps measuring less than 1cm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A: Hemoclips', 'description': 'In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop'}, {'id': 'BG001', 'title': 'Group B: Conventional Polipectomy', 'description': 'In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.05', 'spread': '10.99', 'groupId': 'BG000'}, {'value': '65.55', 'spread': '12.68', 'groupId': 'BG001'}, {'value': '64.5', 'spread': '11.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'whyStopped': 'The unexpected increase in morbidity of the hemoclip group', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-25', 'studyFirstSubmitDate': '2012-03-27', 'resultsFirstSubmitDate': '2012-03-28', 'studyFirstSubmitQcDate': '2012-03-27', 'lastUpdatePostDateStruct': {'date': '2012-05-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-25', 'studyFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Polyps With Complications After Polypectomy (The Total Complication Rate)', 'timeFrame': 'Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding', 'description': 'In order to test the ability of prophylactic hemoclipping to prevent post-polypectomy bleeding, the investigators were required to register all the adverse events that occurred. These adverse events were called "complications", despite their severity and clinical significance'}], 'secondaryOutcomes': [{'measure': 'Difficult to Place the Clip', 'timeFrame': 'During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted)', 'description': 'The hemoclips which were incorrectly placed, mainly because the pedicles were very thick and/or short.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postpolypectomy Bleeding']}, 'referencesModule': {'references': [{'pmid': '23687606', 'type': 'DERIVED', 'citation': 'Quintanilla E, Castro JL, Rabago LR, Chico I, Olivares A, Ortega A, Vicente C, Carbo J, Gea F. Is the use of prophylactic hemoclips in the endoscopic resection of large pedunculated polyps useful? A prospective and randomized study. J Interv Gastroenterol. 2012 Oct;2(4):183-188. doi: 10.4161/jig.23741. Epub 2012 Oct 1.'}, {'pmid': '23687598', 'type': 'DERIVED', 'citation': 'Quintanilla E, Castro JL, Rabago LR, Chico I, Olivares A, Ortega A, Vicente C, Carbo J, Gea F. Is the use of prophylactic hemoclips in the endoscopic resection of large pedunculated polyps useful? A prospective and randomized study. J Interv Gastroenterol. 2012 Apr;2(2):99-104. doi: 10.4161/jig.22210. Epub 2012 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of our study is to analyze the advantages of the prophylactic use of hemoclips before polypectomy in our usual clinical practice, through a prospective randomized study that determines their effectiveness compared to conventional polypectomy, assessing the decrease in immediate and delayed post-polypectomy bleeding', 'detailedDescription': 'The methods for preventing post-polypectomy bleeding (PPB) are not standardised and there are groups that use hemoclips for this purpose.\n\nThe aim of our study is to analyze whether the use of hemoclips reduces PPB complications. It is a prospective, randomised study of patients with pedunculated polyps larger than 10mm. The patients were included in two groups (hemoclip before polypectomy -HC- and standard polypectomy -SP-)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with one or more pedunculated polyps, the heads of which measured more than 1cm (regardless of the stalk thickness and length), and they were compared against the size of the biopsy forceps (6mm) and subsequently confirmed in the anatomical specimen\n* Not to have any hemostatic alterations at the time the endoscopy was performed (confirmed by the usual blood tests taken before the procedure).\n\nExclusion Criteria:\n\n* Patients younger than 18 years of age\n* Patients with a platelet count of less than 50000, INR larger than 1.5\n* Patients who refused to give their informed consent.'}, 'identificationModule': {'nctId': 'NCT01565993', 'briefTitle': 'The Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Severo Ochoa'}, 'officialTitle': 'Is the Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps Useful? A Prospective and Randomized Study', 'orgStudyIdInfo': {'id': 'EQCLIPS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hemoclip', 'description': 'In group HEMOCLIP, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop', 'interventionNames': ['Device: Hemoclip']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Polipectomy', 'description': 'In group CONVENTIONAL POLYPECTOMY, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique', 'interventionNames': ['Device: Conventional Polipectomy']}], 'interventions': [{'name': 'Hemoclip', 'type': 'DEVICE', 'description': 'A rotatable clip-fixing device "Quickclip 2" standard was used (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan), with an opening diameter of 135º and a maximum insertion portion diameter of 2.6 mm', 'armGroupLabels': ['Hemoclip']}, {'name': 'Conventional Polipectomy', 'type': 'DEVICE', 'description': 'Disposable electrosurgical snares (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan) and an electrosurgery unit ERBE (ERBE Elektromedizin GmbH, Germany) were used for polyp resection', 'armGroupLabels': ['Conventional Polipectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28911', 'city': 'Leganés', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Severo Ochoa', 'geoPoint': {'lat': 40.32718, 'lon': -3.7635}}], 'overallOfficials': [{'name': 'Elvira M Quintanilla, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Severo Ochoa'}, {'name': 'Luis R Rábago, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitario Severo Ochoa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Severo Ochoa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Elvira Quintanilla', 'investigatorAffiliation': 'Hospital Severo Ochoa'}}}}