Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-06 @ 10:55 PM
Study NCT ID:
NCT03037034
Status:
COMPLETED
Last Update Posted:
2017-01-31
First Post:
2017-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Endoscopic Resection of Upper Gastrointestinal Subepithelial Tumors Originating From the Muscularis Propria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013525', 'term': 'Surgical Instruments'}], 'ancestors': [{'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2017-01-30', 'lastUpdatePostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete resection rate', 'timeFrame': '1 week', 'description': 'Proportion of study patients with a histologically confirmed diagnosis after Forcep Strip Method'}], 'secondaryOutcomes': [{'measure': 'The mean procedure time', 'timeFrame': '1day', 'description': 'procedure time of submucosal tumor removal using forcep strip method'}, {'measure': 'mean tumor size', 'timeFrame': '1day', 'description': 'tumor size of submucosal tumor removed by forcep strip method'}, {'measure': 'the mean hospitalization time', 'timeFrame': '1week', 'description': 'patient hospitalization time during submucosal tumor removal'}, {'measure': 'Adverse Events', 'timeFrame': '5 days', 'description': 'Peri-interventional adverse events whether related or not'}, {'measure': 'Tumor status after endoscopic resection', 'timeFrame': '10 months', 'description': 'Local result during follow up after Forcep Strip Method'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Subepithelial Tumor']}, 'descriptionModule': {'briefSummary': 'Endoscopic submucosal tumor resection using biopsy forceps was performed for 11 consecutive patients who had clinical indications for lesion removal. Following the injection around a submucosal tumor, the adjacent mucosa or submucosa was grasped with the forceps and pulled away to form a "tent". The tissue was dissected using an electrocoagulating current. In brief, the tumor was dissected from the muscularis propria layer and then carefully removed using forceps. Demographic data, indication for intervention, safety of the procedure and follow-up will be assessed.', 'detailedDescription': 'After the target lesion was identified, several marking dots were made around the lesion, using the hot biopsy forcep. A 0.9% saline solution mixed with epinephrine (1:10,000) and indigo carmine dye was injected along the border of the tumor to raise the gastric mucosa. Then, a circumferential incision was made along the margin of the targeted lesion, using the hot biopsy forceps, and the superficial mucosa was removed. Repeated injection was performed into the submucosal layer. The surrounding tissue was then carefully dissected using the hot biopsy forceps to the level of the deepest submucosal layer. The adjacent tissue was grasped using the forceps and pulled away, forming a "tent". To ensure complete resection, the muscular fibers and stalks that connected the tumor to the propria layer were shelled along the capsule of the tumor, using the coagulating forceps. The investigators used a coagulating forceps when strip the tissue of the outer longitudinal layer. Visible blood vessels in the submucosal layer were directly coagulated using coagulating forceps. After the lesion was removed, further visible blood vessels were coagulated. The hot biopsy forcep was used to apply a forced coagulation current (80 W, Effect 2, VIO300D; Erbe, Germany). However, coagulating forceps with a soft coagulation current (60 W, Effect 6, VIO300D; Erbe, Germany) were used to cut muscle fibers adjacent to the tumor or hemostasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. the tumor size had increased on the follow up gastroscopy,\n2. the EUS showed a well demarcated GI SET, or\n3. they requested an endoscopic excision because the tumor was causing them anxiety.\n\nExclusion Criteria:\n\n1. they had predominantly extraluminal growth,\n2. they were ill demarcated, or\n3. the EUS showed adjacent lymph nodes with a malignant appearance.'}, 'identificationModule': {'nctId': 'NCT03037034', 'briefTitle': 'Novel Endoscopic Resection of Upper Gastrointestinal Subepithelial Tumors Originating From the Muscularis Propria', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': 'Novel Endoscopic Resection of Upper Gastrointestinal Subepithelial Tumors Originating From the Muscularis Propria: a Promising Forcep Strip Method', 'orgStudyIdInfo': {'id': 'Novel Forcep Srip Method'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Forcep Strip Method Treatment', 'description': 'patients who have Gastrointestinal Subepithelial Tumors Originating from the Muscularis Propria are enrolled', 'interventionNames': ['Device: Forcep']}], 'interventions': [{'name': 'Forcep', 'type': 'DEVICE', 'description': 'Following the injection around a submucosal tumor, the adjacent mucosa or submucosa was grasped with the forceps and pulled away to form a "tent". The tissue was dissected using an electrocoagulating current.', 'armGroupLabels': ['Forcep Strip Method Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '136-705', 'city': 'Seoul', 'state': 'Anamdong , Seongbuk-gu', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hoon Jai Chun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'In-Kyung Yoo', 'investigatorAffiliation': 'Korea University Anam Hospital'}}}}