Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT06128018
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2023-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2023-10-24', 'studyFirstSubmitQcDate': '2023-11-09', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify safety profile EUS-GJ', 'timeFrame': '24 Months', 'description': 'The severity of AEs will be determined using standard American Society of Gastrointestinal Endoscopy (ASGE) Lexicon and AGREE criteria (appendix) in the EUS-GJ group.'}], 'secondaryOutcomes': [{'measure': 'Identify safety profile for S-GJ', 'timeFrame': '24 Months', 'description': 'The severity of AEs will be determined using Claviden-Dindo classification of surgical complications in the S-GJ group.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Gastric Outlet Obstruction']}, 'referencesModule': {'references': [{'pmid': '21704805', 'type': 'BACKGROUND', 'citation': 'ASGE Standards of Practice Committee; Fukami N, Anderson MA, Khan K, Harrison ME, Appalaneni V, Ben-Menachem T, Decker GA, Fanelli RD, Fisher L, Ikenberry SO, Jain R, Jue TL, Krinsky ML, Maple JT, Sharaf RN, Dominitz JA. The role of endoscopy in gastroduodenal obstruction and gastroparesis. Gastrointest Endosc. 2011 Jul;74(1):13-21. doi: 10.1016/j.gie.2010.12.003. No abstract available.'}, {'pmid': '17939415', 'type': 'BACKGROUND', 'citation': 'Medina-Franco H, Abarca-Perez L, Espana-Gomez N, Salgado-Nesme N, Ortiz-Lopez LJ, Garcia-Alvarez MN. Morbidity-associated factors after gastrojejunostomy for malignant gastric outlet obstruction. Am Surg. 2007 Sep;73(9):871-5.'}, {'pmid': '11808972', 'type': 'BACKGROUND', 'citation': 'Adler DG, Baron TH. Endoscopic palliation of malignant gastric outlet obstruction using self-expanding metal stents: experience in 36 patients. Am J Gastroenterol. 2002 Jan;97(1):72-8. doi: 10.1111/j.1572-0241.2002.05423.x.'}, {'pmid': '25680897', 'type': 'BACKGROUND', 'citation': 'Tyberg A, Kumta N, Karia K, Zerbo S, Sharaiha RZ, Kahaleh M. EUS-guided gastrojejunostomy after failed enteral stenting. Gastrointest Endosc. 2015 Apr;81(4):1011-2. doi: 10.1016/j.gie.2014.10.018. Epub 2015 Feb 11. No abstract available.'}, {'pmid': '26092615', 'type': 'BACKGROUND', 'citation': 'Khashab MA, Tieu AH, Azola A, Ngamruengphong S, El Zein MH, Kumbhari V. EUS-guided gastrojejunostomy for management of complete gastric outlet obstruction. Gastrointest Endosc. 2015 Oct;82(4):745. doi: 10.1016/j.gie.2015.05.017. Epub 2015 Jun 16. No abstract available.'}, {'pmid': '25155270', 'type': 'BACKGROUND', 'citation': 'Itoi T, Ishii K, Tanaka R, Umeda J, Tonozuka R. Current status and perspective of endoscopic ultrasonography-guided gastrojejunostomy: endoscopic ultrasonography-guided double-balloon-occluded gastrojejunostomy (with videos). J Hepatobiliary Pancreat Sci. 2015 Jan;22(1):3-11. doi: 10.1002/jhbp.148. Epub 2014 Aug 24.'}, {'pmid': '26282674', 'type': 'BACKGROUND', 'citation': 'Itoi T, Ishii K, Ikeuchi N, Sofuni A, Gotoda T, Moriyasu F, Dhir V, Teoh AY, Binmoeller KF. Prospective evaluation of endoscopic ultrasonography-guided double-balloon-occluded gastrojejunostomy bypass (EPASS) for malignant gastric outlet obstruction. Gut. 2016 Feb;65(2):193-5. doi: 10.1136/gutjnl-2015-310348. Epub 2015 Aug 17. No abstract available.'}, {'pmid': '22531985', 'type': 'BACKGROUND', 'citation': 'Binmoeller KF, Shah JN. Endoscopic ultrasound-guided gastroenterostomy using novel tools designed for transluminal therapy: a porcine study. Endoscopy. 2012 May;44(5):499-503. doi: 10.1055/s-0032-1309382. Epub 2012 Apr 24.'}, {'pmid': '25527056', 'type': 'BACKGROUND', 'citation': 'Barthet M, Binmoeller KF, Vanbiervliet G, Gonzalez JM, Baron TH, Berdah S. Natural orifice transluminal endoscopic surgery gastroenterostomy with a biflanged lumen-apposing stent: first clinical experience (with videos). Gastrointest Endosc. 2015 Jan;81(1):215-8. doi: 10.1016/j.gie.2014.09.039.'}, {'pmid': '24237949', 'type': 'BACKGROUND', 'citation': 'Itoi T, Itokawa F, Uraoka T, Gotoda T, Horii J, Goto O, Moriyasu F, Moon JH, Kitagawa Y, Yahagi N. Novel EUS-guided gastrojejunostomy technique using a new double-balloon enteric tube and lumen-apposing metal stent (with videos). Gastrointest Endosc. 2013 Dec;78(6):934-939. doi: 10.1016/j.gie.2013.09.025.'}, {'pmid': '26215646', 'type': 'BACKGROUND', 'citation': 'Khashab MA, Kumbhari V, Grimm IS, Ngamruengphong S, Aguila G, El Zein M, Kalloo AN, Baron TH. EUS-guided gastroenterostomy: the first U.S. clinical experience (with video). Gastrointest Endosc. 2015 Nov;82(5):932-8. doi: 10.1016/j.gie.2015.06.017. Epub 2015 Jul 26.'}, {'pmid': '27004243', 'type': 'BACKGROUND', 'citation': 'Tyberg A, Perez-Miranda M, Sanchez-Ocana R, Penas I, de la Serna C, Shah J, Binmoeller K, Gaidhane M, Grimm I, Baron T, Kahaleh M. Endoscopic ultrasound-guided gastrojejunostomy with a lumen-apposing metal stent: a multicenter, international experience. Endosc Int Open. 2016 Mar;4(3):E276-81. doi: 10.1055/s-0042-101789.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction.', 'detailedDescription': "The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction. The main question this study aims to answer is:\n\n1\\. To compare the rates of procedure related adverse events (AE's) between patients undergoing Endoscopy Ultrasound-guided gastro-jejunostomy (EUS-GJ) and Surgical gastro-jejunostomy (S-GJ).\n\nStudy participants will be randomized into one of the two standard procedures and followed for up to 12 months post procedure for collection of outcomes related data"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. ≥ 18 years of age.\n2. Radiographic OR Endoscopic evidence of an obstructing neoplasm in the distal stomach or duodenum.\n3. GOOSS of 0 or 1\n4. BOTH surgical and endoscopic GJ are technically and clinically feasible\n5. Can understand and is willing to sign informed consent form prior to the initiation of any study procedures (or when applicable the subject's LAR).\n\nExclusion Criteria:\n\n1. \\< 18 years of age\n2. ECOG \\>2\n3. Expected survival (determined by the treating oncologist) is less than 2 months.\n4. Candidates for potential resection of the cancer and obstructed anatomical area (this includes patients with borderline resectable pancreatic cancer)\n5. Peritoneal carcinomatosis with associated bowel obstruction on imaging or during laparoscopy\n6. Large volume ascites (patients with moderate volume ascites may undergo IR guided drainage prior to randomization)\n7. Anatomical factors that technically hinder EUS-GJ OR Surgical-GJ (diffuse tumor involvement in path of LAMS or surgery, surgically altered anatomy that interferes with the ability to perform an anastomosis etc)\n8. Pregnancy"}, 'identificationModule': {'nctId': 'NCT06128018', 'acronym': 'RESTORE', 'briefTitle': 'Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'A Randomized Trial Comparing Endoscopic UltraSound-guided GasTrojejunostomy (EUS-GJ) and Surgical GastrojejunOstomy (S-GJ) for the Management of Malignant gastRic outlEt Obstruction', 'orgStudyIdInfo': {'id': '2036763'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'EUS-guided gastrojejunostomy (EUS-GJ)', 'description': 'Patients on this arm will undergo the endoscopic procedure.', 'interventionNames': ['Procedure: Surgical gastrojejunostomy (S-GJ)']}, {'type': 'OTHER', 'label': 'Surgical gastrojejunostomy (S-GJ)', 'description': 'Patients on this arm will undergo the surgical procedure.', 'interventionNames': ['Procedure: EUS-guided gastrojejunostomy (EUS-GJ)']}], 'interventions': [{'name': 'Surgical gastrojejunostomy (S-GJ)', 'type': 'PROCEDURE', 'description': 'Surgical gastro-jejunostomy', 'armGroupLabels': ['EUS-guided gastrojejunostomy (EUS-GJ)']}, {'name': 'EUS-guided gastrojejunostomy (EUS-GJ)', 'type': 'PROCEDURE', 'description': 'Endoscopic Ultrasound guided gastro-jejunostomy', 'armGroupLabels': ['Surgical gastrojejunostomy (S-GJ)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diana Paredes, RN', 'role': 'CONTACT', 'email': 'Diana.Paredes@adventHealth.com', 'phone': '407-303-9736'}, {'name': 'Petronio Martins, MHA', 'role': 'CONTACT', 'email': 'Petronio.Martins@AdventHealth.com', 'phone': '(407) 303-5503'}, {'name': 'Kambiz Kadkhodayan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dennis Yang, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Natalie Cosgrove, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Deepanshu Jain, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sebastian De La Fuente, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Armando Rosales, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'centralContacts': [{'name': 'Diana Paredes', 'role': 'CONTACT', 'email': 'Diana.Paredes@adventhealth.com', 'phone': '(407)303-9736'}, {'name': 'Petronio Martins', 'role': 'CONTACT', 'email': 'Petronio.martins@adventhealth.com', 'phone': '(407)303-5503'}], 'overallOfficials': [{'name': 'Kambiz Kadkhodayan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AdventHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}