Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.

NCT06128018 | Recruiting DMC

• 1 other identifier: 2036763
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction.

Conditions

Malignant Gastric Outlet Obstruction

Outcome Measures

Primary Outcomes (1)

• Identify safety profile EUS-GJ

  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.

  24 Months

Secondary Outcomes (1)

• Identify safety profile for S-GJ

  24 Months

Study Arms (2)

EUS-guided gastrojejunostomy (EUS-GJ)

OTHER

Patients on this arm will undergo the endoscopic procedure.

Procedure: Surgical gastrojejunostomy (S-GJ)

Surgical gastrojejunostomy (S-GJ)

OTHER

Patients on this arm will undergo the surgical procedure.

Procedure: EUS-guided gastrojejunostomy (EUS-GJ)

Interventions

Surgical gastrojejunostomy (S-GJ) PROCEDURE

Surgical gastro-jejunostomy

EUS-guided gastrojejunostomy (EUS-GJ)

EUS-guided gastrojejunostomy (EUS-GJ) PROCEDURE

Endoscopic Ultrasound guided gastro-jejunostomy

Surgical gastrojejunostomy (S-GJ)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age.
• Radiographic OR Endoscopic evidence of an obstructing neoplasm in the distal stomach or duodenum.
• GOOSS of 0 or 1
• BOTH surgical and endoscopic GJ are technically and clinically feasible
• 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).

You may not qualify if:

• \< 18 years of age
• ECOG \>2
• Expected survival (determined by the treating oncologist) is less than 2 months.
• Candidates for potential resection of the cancer and obstructed anatomical area (this includes patients with borderline resectable pancreatic cancer)
• Peritoneal carcinomatosis with associated bowel obstruction on imaging or during laparoscopy
• Large volume ascites (patients with moderate volume ascites may undergo IR guided drainage prior to randomization)
• 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)
• Pregnancy

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

AdventHealth Orlando

Orlando, Florida, 32804, United States

RECRUITING

Related Publications (12)

• 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: 21704805 BACKGROUND

• 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: 17939415 BACKGROUND

• 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: 11808972 BACKGROUND

• 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: 25680897 BACKGROUND

• 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: 26092615 BACKGROUND

• 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: 25155270 BACKGROUND

• 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: 26282674 BACKGROUND

• 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: 22531985 BACKGROUND

• 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: 25527056 BACKGROUND

• 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: 24237949 BACKGROUND

• 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: 26215646 BACKGROUND

• 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.

  PMID: 27004243 BACKGROUND

Study Officials

• Kambiz Kadkhodayan, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Paredes

CONTACT

(407)303-9736; Diana.Paredes@adventhealth.com

Petronio Martins

CONTACT

(407)303-5503; Petronio.martins@adventhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 13, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): September 8, 2026
• Study Completion (Estimated): March 8, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)