Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-31 @ 1:15 AM
Study NCT ID:
NCT05258604
Status:
UNKNOWN
Last Update Posted:
2022-02-28
First Post:
2022-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Band Ligation Vs APC in Management of GAVE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020252', 'term': 'Gastric Antral Vascular Ectasia'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D016888', 'term': 'Angiodysplasia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057908', 'term': 'Argon Plasma Coagulation'}], 'ancestors': [{'id': 'D004564', 'term': 'Electrocoagulation'}, {'id': 'D002425', 'term': 'Cautery'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006489', 'term': 'Hemostatic Techniques'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D006488', 'term': 'Hemostasis, Surgical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-17', 'studyFirstSubmitDate': '2022-01-21', 'studyFirstSubmitQcDate': '2022-02-17', 'lastUpdatePostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of gastric antral vascular ectasia (GAVE) among other causes of gastrointestinal bleeding and study different endoscopic modalities in GAVE management according to its side effects and capacity in management of GAVE', 'timeFrame': 'two years', 'description': 'prevalence OF GAVE will be assessed according to number of cases presented by gastrointestinal bleeding diagnosed as GAVE by upper endoscopy\n\nside effects of endoscopic modalities will be assessed according\n\n1. incidence of re-bleeding\n2. Need for blood transfusion according to numbers of packed red blood cells units.\n3. Hospital stay and total cost.\n4. post procedure gastric ulceration detected by upper endoscopy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['GAVE - Gastric Antral Vascular Ectasia']}, 'referencesModule': {'references': [{'pmid': '29255747', 'type': 'BACKGROUND', 'citation': 'Zepeda-Gomez S. Endoscopic Treatment for Gastric Antral Vascular Ectasia: Current Options. GE Port J Gastroenterol. 2017 Jul;24(4):176-182. doi: 10.1159/000453271. Epub 2016 Dec 21.'}, {'pmid': '23330048', 'type': 'BACKGROUND', 'citation': 'Fuccio L, Mussetto A, Laterza L, Eusebi LH, Bazzoli F. Diagnosis and management of gastric antral vascular ectasia. World J Gastrointest Endosc. 2013 Jan 16;5(1):6-13. doi: 10.4253/wjge.v5.i1.6.'}, {'pmid': '23418384', 'type': 'BACKGROUND', 'citation': 'Hung EW, Mayes MD, Sharif R, Assassi S, Machicao VI, Hosing C, St Clair EW, Furst DE, Khanna D, Forman S, Mineishi S, Phillips K, Seibold JR, Bredeson C, Csuka ME, Nash RA, Wener MH, Simms R, Ballen K, Leclercq S, Storek J, Goldmuntz E, Welch B, Keyes-Elstein L, Castina S, Crofford LJ, Mcsweeney P, Sullivan KM. Gastric antral vascular ectasia and its clinical correlates in patients with early diffuse systemic sclerosis in the SCOT trial. J Rheumatol. 2013 Apr;40(4):455-60. doi: 10.3899/jrheum.121087. Epub 2013 Feb 15.'}, {'pmid': '29399041', 'type': 'BACKGROUND', 'citation': 'Hsu WH, Wang YK, Hsieh MS, Kuo FC, Wu MC, Shih HY, Wu IC, Yu FJ, Hu HM, Su YC, Wu DC. Insights into the management of gastric antral vascular ectasia (watermelon stomach). Therap Adv Gastroenterol. 2018 Jan 14;11:1756283X17747471. doi: 10.1177/1756283X17747471. eCollection 2018.'}, {'pmid': '12612530', 'type': 'BACKGROUND', 'citation': 'Kantsevoy SV, Cruz-Correa MR, Vaughn CA, Jagannath SB, Pasricha PJ, Kalloo AN. Endoscopic cryotherapy for the treatment of bleeding mucosal vascular lesions of the GI tract: a pilot study. Gastrointest Endosc. 2003 Mar;57(3):403-6. doi: 10.1067/mge.2003.115.'}, {'pmid': '19028211', 'type': 'BACKGROUND', 'citation': 'American Society for Gastrointestinal Endoscopy Technology Committee. Mucosal ablation devices. Gastrointest Endosc. 2008 Dec;68(6):1031-42. doi: 10.1016/j.gie.2008.06.018. No abstract available.'}, {'pmid': '17140926', 'type': 'BACKGROUND', 'citation': 'Sinha SK, Udawat HP, Varma S, Lal A, Rana SS, Bhasin DK. Watermelon stomach treated with endoscopic band ligation. Gastrointest Endosc. 2006 Dec;64(6):1028-31. doi: 10.1016/j.gie.2006.05.006. Epub 2006 Aug 22. No abstract available.'}, {'pmid': '23808945', 'type': 'BACKGROUND', 'citation': 'Keohane J, Berro W, Harewood GC, Murray FE, Patchett SE. Band ligation of gastric antral vascular ectasia is a safe and effective endoscopic treatment. Dig Endosc. 2013 Jul;25(4):392-6. doi: 10.1111/j.1443-1661.2012.01410.x. Epub 2012 Dec 17.'}, {'pmid': '22725108', 'type': 'BACKGROUND', 'citation': 'Sato T, Yamazaki K, Akaike J. Endoscopic band ligation versus argon plasma coagulation for gastric antral vascular ectasia associated with liver diseases. Dig Endosc. 2012 Jul;24(4):237-42. doi: 10.1111/j.1443-1661.2011.01221.x. Epub 2011 Dec 29.'}]}, 'descriptionModule': {'briefSummary': '* overall aim: To compare the efficacy and safety of endoscopic band ligation and endoscopic argon plasma coagulation for the management of gastric antral vascular ectasia.\n* Secondary aims:\n\n 1. Study risk factors of GAVE.\n 2. Prevalence of GAVE among causes of non-variceal gastrointestinal bleeding.', 'detailedDescription': 'Gastric antral vascular ectasia (GAVE) is a capillary-type vascular malformation characterized endoscopically by red, angiomatous lesions originating in the antrum and organized either in stripes or in a diffuse pattern.\n\nGAVE may cause chronic iron-deficiency anemia with or without the presence of overt gastrointestinal bleeding, manifested commonly by melena, may account for about 4% of the causes of non-variceal bleeding.\n\nGAVE can be isolated or associated with systemic conditions, especially in patients with liver cirrhosis, scleroderma, chronic renal failure, and after bone marrow transplantation.\n\nMultiple mechanisms have been proposed as the origin of its development. These have included gastric dysmotility leading to chronic mucosal trauma and subsequent fibromuscular hyperplasia and vascular ectasia or an autoimmune reaction to gastric blood vessels among the main contributing factors.\n\nManagement of GAVE-related gastrointestinal bleeding is a clinically challenging issue. In the last two decades, many therapeutic options and modalities have been applied for GAVE including medical, endoscopic, and surgical management.\n\nEndoscopic management including different options such as cryotherapy, argon photo coagulation (APC), Neodymium-yttrium-aluminum garnet laser coagulation, radiofrequency ablation and endoscopic band ligation.\n\nThe first case using endoscopic band ligation as salvage treatment for GAVE was reported in 2006. After two sessions of EBL with a Multi-Band Ligature, hemoglobin became stable and serum ferritin normalized in 16 months of follow up.\n\nSome studies show that management of GAVE with endoscopic band ligation superior to APC in bleeding cessation and fewer treatment sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Both sexes will be included.\n\n * Age above 18 years old patients will be included.\n * With overt or occult bleeding from GAVE.\n * Characteristic endoscopic findings of GAVE: GAVE was limited to the antrum and its appearance either watermelon stomach or diffuse pattern.\n\nExclusion Criteria:\n\n* • All causes of emergence upper GIT bleeding other than GAVE.\n\n * Patient with contraindication to general anesthesia'}, 'identificationModule': {'nctId': 'NCT05258604', 'briefTitle': 'Endoscopic Band Ligation Vs APC in Management of GAVE', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Endoscopic Band Ligation Versus Argon Plasma Coagulation in Management of Gastric Antral Vascular Ectasia; Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'endoscopic management of GAVE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'argon plasma coagulation (APC).', 'description': 'APC Standard APC equipment will be used, consisting of a high-frequency electrosurgical generator (ICC 350; ERBE, Tübingen, Germany), an argon source which is regulated automatically (APC 300) and APC probe.', 'interventionNames': ['Procedure: argon plasma coagulation']}, {'type': 'EXPERIMENTAL', 'label': 'endoscopic band ligation.', 'description': 'endoscopic band ligation will be carried out using a Saeed Multi-Band Ligator (Cook Medical, WinstonSalem, NC), and ligation bands were placed on the GAVE.', 'interventionNames': ['Procedure: endoscopic band ligation']}], 'interventions': [{'name': 'argon plasma coagulation', 'type': 'PROCEDURE', 'description': 'APC Standard APC equipment will be used, consisting of a high-frequency electrosurgical generator (ICC 350; ERBE, Tübingen, Germany), an argon source which is regulated automatically (APC 300) and APC probe.', 'armGroupLabels': ['argon plasma coagulation (APC).']}, {'name': 'endoscopic band ligation', 'type': 'PROCEDURE', 'description': 'endoscopic band ligation will be carried out using a Saeed Multi-Band Ligator (Cook Medical, WinstonSalem, NC), and ligation bands were placed on the GAVE.', 'armGroupLabels': ['endoscopic band ligation.']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Esraa swifee, assistant lecturer', 'role': 'CONTACT', 'email': 'esraayousef27@yahoo.com', 'phone': '00201000700150'}, {'name': 'osman abdelhameed, professor', 'role': 'CONTACT', 'phone': '00201222302355'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Esraa Yousef Mohammed', 'investigatorAffiliation': 'Assiut University'}}}}