Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.
NCT ID: NCT06128018
Last Updated: 2024-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2023-11-01
2026-07-31
Brief Summary
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Detailed Description
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1\. 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).
Study 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EUS-guided gastrojejunostomy (EUS-GJ)
Patients on this arm will undergo the endoscopic procedure.
Surgical gastrojejunostomy (S-GJ)
Surgical gastro-jejunostomy
Surgical gastrojejunostomy (S-GJ)
Patients on this arm will undergo the surgical procedure.
EUS-guided gastrojejunostomy (EUS-GJ)
Endoscopic Ultrasound guided gastro-jejunostomy
Interventions
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Surgical gastrojejunostomy (S-GJ)
Surgical gastro-jejunostomy
EUS-guided gastrojejunostomy (EUS-GJ)
Endoscopic Ultrasound guided gastro-jejunostomy
Eligibility Criteria
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Inclusion Criteria
2. Radiographic OR Endoscopic evidence of an obstructing neoplasm in the distal stomach or duodenum.
3. GOOSS of 0 or 1
4. BOTH surgical and endoscopic GJ are technically and clinically feasible
5. 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).
Exclusion Criteria
2. ECOG \>2
3. Expected survival (determined by the treating oncologist) is less than 2 months.
4. Candidates for potential resection of the cancer and obstructed anatomical area (this includes patients with borderline resectable pancreatic cancer)
5. Peritoneal carcinomatosis with associated bowel obstruction on imaging or during laparoscopy
6. Large volume ascites (patients with moderate volume ascites may undergo IR guided drainage prior to randomization)
7. 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)
8. Pregnancy
18 Years
ALL
No
Sponsors
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AdventHealth
OTHER
Responsible Party
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Principal Investigators
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Kambiz Kadkhodayan, MD
Role: PRINCIPAL_INVESTIGATOR
AdventHealth
Locations
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AdventHealth Orlando
Orlando, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2036763
Identifier Type: -
Identifier Source: org_study_id
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