Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT04220905
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2019-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2019-12-27', 'studyFirstSubmitQcDate': '2020-01-06', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of severe complications', 'timeFrame': 'Up to 14 days following the procedure.', 'description': 'Aggregate of all severe adverse events that occur at the time of the procedure or during and up to 14 days of follow-up. Severe adverse events include bleeding, perforation, postpolypectomy syndrome, and clinical events that require an admission to the hospital.'}, {'measure': 'Completeness of polyp resection', 'timeFrame': 'During the procedure', 'description': 'Complete polyp removal is defined as removal of all visible polyp tissue at the end of the EMR, as assessed by the endoscopist.'}, {'measure': 'Polyp recurrence', 'timeFrame': 'Up to 5 years (at next scheduled surveillance colonoscopy).', 'description': 'Presence of biopsy proven neoplastic polyp tissue at the EMR resection site at surveillance endoscopy following complete polyp resection.'}], 'secondaryOutcomes': [{'measure': 'Severe bleeding complications', 'timeFrame': 'Up to 14 days following the procedure.', 'description': 'Severe bleeding is defined as the need for hospitalization, transfusion, a repeat endoscopy, surgery, or interventional radiology, up to 14 days following the procedure.'}, {'measure': 'Perforation', 'timeFrame': 'Up to 14 days following the procedure.', 'description': 'Defined as a complete hole, or full-thickness resection of the muscularis propria (Sydney Classification of Deep Mural Injury Type IV)'}, {'measure': 'Postpolypectomy syndrome', 'timeFrame': 'Following the procedure up to 14 days.', 'description': 'Defined as abdominal pain severe enough to warrant an ED visit or hospital admission and presence of leukocytosis and/or required treatment with antibiotics.'}, {'measure': 'Efficacy of submucosal injectate', 'timeFrame': 'During the procedure.', 'description': 'Volume of solution per lesion size (mL/cm2), time of resection.'}, {'measure': 'Intraprocedural bleeding', 'timeFrame': 'During the procedure', 'description': 'Immediate bleeding that requires endoscopic intervention to stop the bleeding (e.g. clip placement or snare tip soft coagulation or coagulation grasper).'}, {'measure': 'Need for colon resection', 'timeFrame': 'Up to 3 years following the procedure.', 'description': 'Patients who require surgery for polyp removal or as a result of complications related to the EMR or follow up procedures.'}, {'measure': 'Technical skill of the endoscopist', 'timeFrame': 'During the procedure', 'description': 'To perform video based assessment of endoscopic resection skills'}, {'measure': 'Cold snare of duodenal adenomas greater than 10 mm', 'timeFrame': 'Up to 3 years following baseline procedure', 'description': 'Safety, efficacy, recurrence of neoplastic polyp at first surveillance endoscopy, serious adverse events'}, {'measure': 'Cold snare of Paris IIa polyps greater than 20 mm', 'timeFrame': '1 year following baseline procedure', 'description': 'Safety, efficacy, recurrence, serious adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colonic Polyp', 'Colonoscopy', 'Complication', 'Recurrence', 'Duodenal Polyp']}, 'descriptionModule': {'briefSummary': 'This protocol describes a prospective cohort study. It addresses an important challenge in the prevention of colorectal cancer and duodenal cancer: how to safely and effectively remove large polyps.', 'detailedDescription': 'Over recent years, a number of studies have been published that have highlighted factors associated with improved efficacy and safety of large polyp resection. Almost all of these studies originate from one large Australian cohort. It is unclear, whether the results are generalizable to other populations. It is important to understand if these findings can be duplicated, to further build on the gained knowledge. At the same time the technology of endoscopic resection is evolving.\n\nEstablished in 2012, the Large Polyp Study group aims to prospectively examine outcomes related to endoscopic large polyp removal. Enrollment of an ongoing randomized trial of 920 patients has just been completed and a second trial is planned. The primary aim of both trials is to understand whether a specific intervention will reduce the risk of adverse events. The added observational study will complement the trials in different ways: It will enroll patients who might not have been eligible for the trials and allow the application of other resection techniques. The observational study will therefore better represent the average patient who undergoes resection of a large polyp. Furthermore, it will add sample size to examine secondary outcomes with greater power.\n\nThis is a continuation of NCT01936948 (Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial) as a observational cohort.\n\nThe continuation was approved by the institutional IRB as part of the initial RCT. At this point the investigators document the observational arm as its own study in this registry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient who is known to have a large colorectal polyp or duodenal polyp and are referred for resection of the polyp.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient ≥18 who presents for an upper endoscopy or colonoscopy and who does not have criteria for exclusion\n* Patients with a ≥20mm colon polyp\n* Patients with a ≥10mm duodenal polyp\n\nExclusion Criteria:\n\n* Patients who are receiving an emergency endoscopy\n* Patients with coagulopathy with an elevated INR ≥1.5, or platelets \\<50\n* Poor bowel preparation\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04220905', 'briefTitle': 'Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study', 'organization': {'class': 'FED', 'fullName': 'White River Junction Veterans Affairs Medical Center'}, 'officialTitle': 'Large Polyp Study (LPS) III - Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study', 'orgStudyIdInfo': {'id': 'CPHS 23578'}}, 'contactsLocationsModule': {'locations': [{'zip': '05009', 'city': 'White River Junction', 'state': 'Vermont', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heiko Pohl, MD', 'role': 'CONTACT', 'email': 'heiko.pohl@va.gov', 'phone': '802-295-9363'}, {'name': 'Laura L Jensen, MPH', 'role': 'CONTACT', 'email': 'Laura.Jensen@va.gov', 'phone': '8022959363', 'phoneExt': '6953'}], 'facility': 'White River Junction VAMC', 'geoPoint': {'lat': 43.64896, 'lon': -72.31926}}], 'centralContacts': [{'name': 'Heiko Pohl, MD', 'role': 'CONTACT', 'email': 'heiko.pohl@va.gov', 'phone': '8022959363'}, {'name': 'Laura L Jensen, MPH', 'role': 'CONTACT', 'email': 'Laura.Jensen@va.gov', 'phone': '802-295-9363', 'phoneExt': '6953'}], 'overallOfficials': [{'name': 'Heiko Pohl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'White River Junction Veterans Affairs Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'White River Junction Veterans Affairs Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine, Dartmouth College', 'investigatorFullName': 'Dr. Heiko Pohl', 'investigatorAffiliation': 'White River Junction Veterans Affairs Medical Center'}}}}