Gastric Outlet ObstructionEAT-GONCT05561907
Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy
A study testing Surgical gastrojejunostomy (SGJ) and Endoscopic gastrojejunostomy (EGJ) in people with Gastric Outlet Obstruction, run by Northwell Health at 4 sites in United States.
Trial summary
Gastric outlet obstruction (GOO) occurs commonly in malignancies involving the periampullary region (cancers originating in the head of the pancreas, duodenum, bile duct, or ampulla) or the distal stomach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Outlet Obstruction
- What is being tested?
- Surgical gastrojejunostomy (SGJ) and Endoscopic gastrojejunostomy (EGJ)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Oct 2022to Jun 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
- Periampullary malignancy (pancreas, bile duct, ampulla, duodenum) extending to the distal duodenum (D3) or distal (antrum) gastric cancer
- Symptoms of gastric outlet obstruction (at least 2 of 4 required):
- post prandial vomiting,
- abdominal pain,
- inability to tolerate PO,
- imaging consistent with GOO
Show all 11Show fewer
- Gastric Outlet Obstruction Scoring System (GOOSS) Score of 0 (no oral intake) or 1 (liquids only)
- Age >18 years old
- Life expectancy greater than 2 months or failed duodenal stenting
- Surgical Candidate/Tolerate General Anesthesia
- Unresectable or metastatic disease
Who cannot join
- Age< 18 years old
- Pregnancy
- Intestinal obstruction distal to the Ligament of Treitz
- Evidence of other luminal strictures of the GI tract
- Previous gastric or periampullary surgery
- Inability to complete quality of life surveys (QOLS)
- Presence of abdominal ascites
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 1 recruiting
- Completed
North Shore University Hospital
Manhasset, New York, 11030
- Recruiting
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Molly Stewart, (732) 235-3247, molly.stewart1@rutgers.edu
Petros Benias, MD
- Completed
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
- Completed
Lenox Hill Hospital
New York, New York, 10075
About this study
Gastric outlet obstruction (GOO) occurs commonly in malignancies involving the periampullary region (cancers originating in the head of the pancreas, duodenum, bile duct, or ampulla) or the distal stomach. GOO not only causes debilitating symptoms such as nausea, vomiting, inability to tolerate oral intake, and prevents adequate nutritional intake. Therefore, providing therapy for GOO is imperative to improve the quality of life, and nutritional status of these patients, as well as allow them to continue receiving their cancer treatment
Read the detailed description
After potential subjects are screened from the physicians' schedules, they will be assessed for further inclusion criteria. They will be presented with the informed consent form for their review. Once they have been given the opportunity to review and ask questions, they will sign the consent form and from this point will be considered enrolled into the study.
After signing the informed consent, subjects will be randomized to one of the two cohorts in a 1:1 manner.
On the day of their assigned procedures, subjects will be asked several quality of life questionnaires to obtain a baseline status.
Data will be collected during and immediately following the procedure to assess for any possible adverse events.
Follow-up data will be completed at the following timepoints: 1-day, 2-day, 3-day, 4-day, and 7-day, 30-day, 3-month, 6-month, and 1-year post-procedure.
QOL Scoring Systems GOOSS- Gastric Outlet Obstruction Symptom Score
- 1 Inadequate or no oral intake
- 2 Liquids/thickened liquids
- 3 Semisolids/ low residue
- 4 unmodified
GFS- Gut Function Score from Lowe et al 2002
- 0 Profuse vomiting
- 1 Nausea and occasional vomiting
- 2 Nausea only
- 3 Normal gut function
Pre-Procedure Variables to Record Demographic
- Gender
- Weight
- BMI
- Cancer Type
Clinical Parameters
- GOOSS
- Gut Function Score
- Karnofsky Performance Scale
Procedural Parameters
- EUS-GJ: presence of ascites, able to pass scope beyond obstruction, use of wire to stabilize position, Length of procedure, intraprocedural AEs, Stent size used, successful completion of procedure
- Laparoscopic GJ: presence of ascites, length of procedure, intraprocedural AEs, conversion to open GJ, successful completion of procedure
Post-procedure Hospitalization Daily Function
- GOOSS
- Gut Function Score
- Time to initiation of oral intake liquids
- Time to initiation of oral intake solids
- Time to discharge
- Post procedural AEs 30 Day Outcomes
- GOOSS
- Gut Function Score
- Karnofsky Performance Scale
- Weight/BMI
- Able to tolerate TB approved chemotherapeutic regimen
- Conditions
- Gastric Outlet Obstruction
- Being tested
- Surgical gastrojejunostomy (SGJ), Endoscopic gastrojejunostomy (EGJ)
- Keywords
- Gastric outlet obstruction, GOO, Periampullary malignancy, Periampullary cancer, Surgical gastrojejunostomy, Endoscopic gastrojejunostomy, Gastrojejunostomy, Enteral anastamosis
- Medical subject headings
- Gastric Outlet Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical gastrojejunostomy (SGJ)Procedure or surgery
Laparoscopic gastrojejunostomy
Endoscopic gastrojejunostomy (EGJ)Procedure or surgery
Endoscopic ultrasound (EUS) guided gastrojejunostomy
| Study group | Role | What they receive |
|---|---|---|
| Surgical gastrojejunostomy (SGJ) | Active comparator | An anastomosis will be created between the stomach and the proximal loop of the jejunum during a laparoscopic surgical procedure. Receives: Procedure: Surgical gastrojejunostomy (SGJ) |
| Endoscopic gastrojejunostomy (EGJ) | Experimental | A stent is placed between the stomach and adjacent small intestine under endoscopic ultrasound guidance during an upper endoscopic procedure. Receives: Procedure: Endoscopic gastrojejunostomy (EGJ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to initiation of solid oral intake without symptoms of GOO
Days to initiation of solid oral intake will be measured from randomization to first day of intake of soft solid foods, as indicated by a GOOSS score of 2
Measured: 1 year
Secondary outcomes (10)
Safety of procedure
All adverse events (AEs) occurring after treatment will be graded according to ASGE lexicon. A subject will be considered to have had an adverse event if they had one or more adverse events, and they will be considered to have had a serious adverse event (SAE) if they had one or more serious adverse events
Measured: 1 year
Technical success of procedure
Technical success is defined as adequate deployment and positioning of the stent(s) for EGJ or technical possibility to create an anastomosis for SGJ.
Measured: 1 year
Clinical success of procedure
Clinical success is defined as improvement to a GOOSS score of 2 or 3 (oral intake of soft solid foods or resumption of full diet) without additional intervention.
Measured: 1 year
Time to discharge
Length of stay will be measured from randomization to discharge alive. All patients will be followed until discharge. Patients who die in hospital will be considered censored and time from randomization to death will be used.
Measured: 1 year
Change in BMI
BMI will be measured immediately prior to the procedure, and at one month and three months after the procedure.
Measured: 3 months
Change in albumin levels
Albumin levels will be measured immediately prior to the procedure, and at one month and three months after the procedure.
Measured: 3 months
Change in Gastric Outlet Obstruction Symptom Score (GOOSS)
The Gastric Outlet Obstruction Symptom Score (GOOSS) scale is as follows, whereas a score of 1 is the worst and a score of 4 is the best:
- Inadequate or no oral intake
- Liquids/thickened liquids
- Semisolids/ low residue
- Unmodified
GOOSS will be recorded at each of the following timepoints:
- immediately prior to the procedure
- immediately post-procedure
- 1-day post-procedure
- 2-days post-procedure
- 3-days post-procedure
- 4-days post-procedure
- 7-days post-procedure,
- 30-days post-procedure
- 3-months post-procedure
- 6-months post-procedure
- 1-year post-procedure
Measured: 1 year
Change in Gut Function Score (GFS)
Gut Function Score (GFS) scale is as follows, whereas a score of 1 is the worst and a score of 3 is the best:
- Profuse vomiting
- Nausea and occasional vomiting
- Nausea only
- Normal gut function
GFS will be recorded at each of the following timepoints:
- Immediately prior to the procedure
- Immediately post-procedure
- 1-day post-procedure
- 2-days post-procedure
- 3-days post-procedure
- 4-days post-procedure
- 7-days post-procedure,
- 30-days post-procedure
- 3-months post-procedure
- 6-months post-procedure
- 1-year post-procedure
Measured: 1 year
Karnofsky Performance Scale (KPS)
Karnofsky Performance Scale is measured on a scale of 0 to 100 as follows, with a score of 0 being the worst and a score of 100 being the best:
100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of their personal needs.
50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.
20 - Very sick; hospital admission necessary; active supportive treatment necessary.
10 - Moribund; fatal processes progressing rapidly. 0 - Dead
KPS will be recorded pre-procedure and at 30-days post-procedure.
Measured: 30 Days
Chemotherapeutic regimen tolerance
Ability to tolerate TB approved chemotherapeutic regimen
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start28 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for 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
- Model description
- Subjects will be randomly assigned in a 1:1 ratio to surgical gastrojejunostomy (SGJ) or endoscopic gastrojejunostomy (EGJ).
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers, The State University of New Jersey
- Responsible party
- Principal investigator, Petros Benias, Northwell Health
- Investigators
- Nichol Martinez, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561907
- Sponsor's protocol ID
- 21-1130
- Acronym
- EAT-GO
- Status last verified
- Jun 2026
- First submitted
- 13 Sep 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lorusso D, Giliberti A, Bianco M, Lantone G, Leandro G. Stomach-partitioning gastrojejunostomy is better than conventional gastrojejunostomy in palliative care of gastric outlet obstruction for gastric or pancreatic cancer: a meta-analysis. J Gastrointest Oncol. 2019 Apr;10(2):283-291. doi: 10.21037/jgo.2018.10.10.
PubMed 31032096Troncone E, Fugazza A, Cappello A, Del Vecchio Blanco G, Monteleone G, Repici A, Teoh AYB, Anderloni A. Malignant gastric outlet obstruction: Which is the best therapeutic option? World J Gastroenterol. 2020 Apr 28;26(16):1847-1860. doi: 10.3748/wjg.v26.i16.1847.
PubMed 32390697Maetani I, Inoue H, Sato M, Ohashi S, Igarashi Y, Sakai Y. Peroral insertion techniques of self-expanding metal stents for malignant gastric outlet and duodenal stenoses. Gastrointest Endosc. 1996 Oct;44(4):468-71. doi: 10.1016/s0016-5107(96)70102-5.
PubMed 8905371Tonozuka R, Tsuchiya T, Mukai S, Nagakawa Y, Itoi T. Endoscopic Ultrasonography-Guided Gastroenterostomy Techniques for Treatment of Malignant Gastric Outlet Obstruction. Clin Endosc. 2020 Sep;53(5):510-518. doi: 10.5946/ce.2020.151. Epub 2020 Sep 23.
PubMed 32962331Khashab M, Alawad AS, Shin EJ, Kim K, Bourdel N, Singh VK, Lennon AM, Hutfless S, Sharaiha RZ, Amateau S, Okolo PI, Makary MA, Wolfgang C, Canto MI, Kalloo AN. Enteral stenting versus gastrojejunostomy for palliation of malignant gastric outlet obstruction. Surg Endosc. 2013 Jun;27(6):2068-75. doi: 10.1007/s00464-012-2712-7. Epub 2013 Jan 9.
PubMed 23299137Jeurnink SM, Steyerberg EW, van Hooft JE, van Eijck CH, Schwartz MP, Vleggaar FP, Kuipers EJ, Siersema PD; Dutch SUSTENT Study Group. Surgical gastrojejunostomy or endoscopic stent placement for the palliation of malignant gastric outlet obstruction (SUSTENT study): a multicenter randomized trial. Gastrointest Endosc. 2010 Mar;71(3):490-9. doi: 10.1016/j.gie.2009.09.042. Epub 2009 Dec 8.
PubMed 20003966Jeurnink SM, Steyerberg EW, Hof Gv, van Eijck CH, Kuipers EJ, Siersema PD. Gastrojejunostomy versus stent placement in patients with malignant gastric outlet obstruction: a comparison in 95 patients. J Surg Oncol. 2007 Oct 1;96(5):389-96. doi: 10.1002/jso.20828.
PubMed 17474082Itoi 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 26215646Khashab 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 26092615Carbajo AY, Kahaleh M, Tyberg A. Clinical Review of EUS-guided Gastroenterostomy (EUS-GE). J Clin Gastroenterol. 2020 Jan;54(1):1-7. doi: 10.1097/MCG.0000000000001262.
PubMed 31567785Barthet 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 25527056Ge PS, Young JY, Dong W, Thompson CC. EUS-guided gastroenterostomy versus enteral stent placement for palliation of malignant gastric outlet obstruction. Surg Endosc. 2019 Oct;33(10):3404-3411. doi: 10.1007/s00464-018-06636-3. Epub 2019 Feb 6.
PubMed 30725254Kerdsirichairat T, Irani S, Yang J, Brewer Gutierrez OI, Moran R, Sanaei O, Dbouk M, Kumbhari V, Singh VK, Kalloo AN, Khashab MA. Durability and long-term outcomes of direct EUS-guided gastroenterostomy using lumen-apposing metal stents for gastric outlet obstruction. Endosc Int Open. 2019 Feb;7(2):E144-E150. doi: 10.1055/a-0799-9939. Epub 2019 Jan 30.
PubMed 30705945James TW, Greenberg S, Grimm IS, Baron TH. EUS-guided gastroenteric anastomosis as a bridge to definitive treatment in benign gastric outlet obstruction. Gastrointest Endosc. 2020 Mar;91(3):537-542. doi: 10.1016/j.gie.2019.11.017. Epub 2019 Nov 20.
PubMed 31759034