Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.

Malignant Gastric Outlet Obstruction Clinical Trial

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Official title:

A Randomized Trial Comparing Endoscopic UltraSound-guided GasTrojejunostomy (EUS-GJ) and Surgical GastrojejunOstomy (S-GJ) for the Management of Malignant gastRic outlEt Obstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128018
• Other study ID #: 2036763
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: March 2024
• Source: AdventHealth
• Contact: Diana Paredes
• Phone: (407)303-9736
• Email: Diana.Paredes[@]adventhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 31, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. = 18 years of age.

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:

1. < 18 years of age

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

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Malignant Gastric Outlet Obstruction
• Pyloric Stenosis

Intervention

Procedure:
• Surgical gastrojejunostomy (S-GJ)
Surgical gastro-jejunostomy
• EUS-guided gastrojejunostomy (EUS-GJ)
Endoscopic Ultrasound guided gastro-jejunostomy

Locations

Country	Name	City	State
United States	AdventHealth Orlando	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Identify safety profile for S-GJ	The severity of AEs will be determined using Claviden-Dindo classification of surgical complications in the S-GJ group.	24 Months