Malignant Gastric Outlet ObstructionRESTORENCT06128018
Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.
A study testing Surgical gastrojejunostomy (S-GJ) and EUS-guided gastrojejunostomy (EUS-GJ) in people with Malignant Gastric Outlet Obstruction, run by AdventHealth at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Gastric Outlet Obstruction
- What is being tested?
- Surgical gastrojejunostomy (S-GJ) and EUS-guided gastrojejunostomy (EUS-GJ)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 8 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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).
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32804
Diana Paredes, RN, (407) 303-9736, Diana.Paredes@adventHealth.com
Petronio Martins, MHA, (407) 303-5503, Petronio.Martins@AdventHealth.com
About this study
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
The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction.
Read the detailed 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:
- 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
- Malignant Gastric Outlet Obstruction
- Being tested
- Surgical gastrojejunostomy (S-GJ), EUS-guided gastrojejunostomy (EUS-GJ)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical gastrojejunostomy (S-GJ)Procedure or surgery
Surgical gastro-jejunostomy
EUS-guided gastrojejunostomy (EUS-GJ)Procedure or surgery
Endoscopic Ultrasound guided gastro-jejunostomy
| Study group | Role | What they receive |
|---|---|---|
| EUS-guided gastrojejunostomy (EUS-GJ) | Other | Patients on this arm will undergo the endoscopic procedure. Receives: Procedure: Surgical gastrojejunostomy (S-GJ) |
| Surgical gastrojejunostomy (S-GJ) | Other | Patients on this arm will undergo the surgical procedure. Receives: Procedure: EUS-guided gastrojejunostomy (EUS-GJ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Months
Secondary outcomes (1)
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.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Nov 2023
- Primary completion8 Sep 2026 (estimated)
- Study completion8 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Malignant Gastric Outlet ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kambiz Kadkhodayan, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128018
- Sponsor's protocol ID
- 2036763
- Acronym
- RESTORE
- Status last verified
- Apr 2026
- First submitted
- 24 Oct 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21704805Medina-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.
PubMed 17939415Adler 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.
PubMed 11808972Tyberg 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.
PubMed 25680897Khashab 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.
PubMed 26092615Itoi 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.
PubMed 25155270Itoi 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.
PubMed 26282674Binmoeller 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.
PubMed 22531985Barthet 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.
PubMed 25527056Itoi 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.
PubMed 24237949Khashab 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.
PubMed 26215646Tyberg 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.
PubMed 27004243