NCT03259763

Brief Summary

Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is associated with substantial morbidity. Palliation of GOO has traditionally been through the surgical bypass of the obstructed lumen by creating an opening between the stomach and small intestine. However, In recent years, a less invasive approach, i.e. endoscopic stenting, has gained wide acceptance to treat unresectable malignant gastric outlet obstruction. In this study, the investigators are going to compare the safety and efficacy of the two different endoscopic techniques including Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) and enteral stenting (ES).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
7 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
3.2 years until next milestone

Study Start

First participant enrolled

October 26, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

4.6 years

First QC Date

August 15, 2017

Last Update Submit

March 4, 2026

Conditions

Gastric Outlet Obstruction

Keywords

GastroenterostomyGastric Outlet ObstructionCancerEndosonography

Outcome Measures

Primary Outcomes (1)

  • Rate of gastric outlet obstruction recurrence

    Recurrence of nausea, vomiting, and inability to tolerate PO intake up to 3 months after the procedure confirmed either endoscopically and/or radiographically.

    3 months

Secondary Outcomes (12)

  • Technical success rate

    Day of procedure

  • Clinical success rate

    1 week

  • Length of procedure

    Day of procedure

  • Adverse events rate

    1 week

  • Post-procedure length of hospital stay

    1 week

  • +7 more secondary outcomes

Study Arms (2)

EUS-guided gastroenterostomy (EUS-GE)

ACTIVE COMPARATOR

In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.

Device: Lumen-apposing metal stent

Enteral Stenting (ES)

ACTIVE COMPARATOR

In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.

Device: Self-expandable metal stent

Interventions

Lumen-apposing metal stentDEVICE

In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.

EUS-guided gastroenterostomy (EUS-GE)
Self-expandable metal stentDEVICE

In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.

Enteral Stenting (ES)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with malignant, symptomatic gastric outlet obstruction due to an unresectable malignant lesion
  • Gastric outlet obstruction scoring system (GOOSS) score of 0 (no oral intake) or 1 (liquids only)
  • Age 18-80 years

You may not qualify if:

  • Evidence of other strictures in the gastrointestinal (GI) tract
  • Previous gastric, periampullary or duodenal surgery
  • World Health Organization (WHO) performance score of 4 (patient is 100% of time in bed)
  • Unable to fill out quality of life questionnaire
  • Unable to sign the informed consent
  • Life expectancy of less than 3 months based on the endoscopist's opinion
  • Cancer extending into the body of the stomach, 4th portion of the duodenum or proximal jejunum around the ligament of Treitz
  • Large volume ascites
  • Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other severe comorbidities
  • Pregnant or breastfeeding women
  • Uncorrectable coagulopathy defined by INR \> 1.5 or platelet \< 50000/µl
  • Complete GOO evidenced by inability to either pass a wire across the stricture and/or inability to opacify small bowel distal to the malignant stricture
  • Resectable or borderline resectable tumors
  • One of the two techniques (EUS-GE and ES) cannot be performed (at the discretion of the endoscopist)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Yale University

New Haven, Connecticut, 06520, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Wake Forest Baptist University

Winston-Salem, North Carolina, 27157, United States

Location

The Research Institute of McGill University Health Centre

Montreal, Quebec, Canada

Location

Ecuadorian Institute of Digestive Diseases (IECED)

Guayaquil, Ecuador

Location

Hospital Prive des Peupliers

Paris, France

Location

Asian Institute of Gastroenterology

Hyderabad, India

Location

Emek Medical Center

Afula, 1834111, Israel

Location

Hospital Universitario Rio Hortega

Valladolid, 47012, Spain

Location

Related Publications (9)

  • Mittal A, Windsor J, Woodfield J, Casey P, Lane M. Matched study of three methods for palliation of malignant pyloroduodenal obstruction. Br J Surg. 2004 Feb;91(2):205-9. doi: 10.1002/bjs.4396.

    PMID: 14760669BACKGROUND

  • Johnsson E, Thune A, Liedman B. Palliation of malignant gastroduodenal obstruction with open surgical bypass or endoscopic stenting: clinical outcome and health economic evaluation. World J Surg. 2004 Aug;28(8):812-7. doi: 10.1007/s00268-004-7329-0. Epub 2004 Aug 3.

    PMID: 15457364BACKGROUND

  • Maetani I, Akatsuka S, Ikeda M, Tada T, Ukita T, Nakamura Y, Nagao J, Sakai Y. Self-expandable metallic stent placement for palliation in gastric outlet obstructions caused by gastric cancer: a comparison with surgical gastrojejunostomy. J Gastroenterol. 2005 Oct;40(10):932-7. doi: 10.1007/s00535-005-1651-7.

    PMID: 16261429BACKGROUND

  • Khashab 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.

    PMID: 23299137BACKGROUND

  • 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: 26215646BACKGROUND

  • Itoi T, Baron TH, Khashab MA, Tsuchiya T, Irani S, Dhir V, Bun Teoh AY. Technical review of endoscopic ultrasonography-guided gastroenterostomy in 2017. Dig Endosc. 2017 May;29(4):495-502. doi: 10.1111/den.12794. Epub 2017 Jan 27.

    PMID: 28032663BACKGROUND

  • Chen YI, Itoi T, Baron TH, Nieto J, Haito-Chavez Y, Grimm IS, Ismail A, Ngamruengphong S, Bukhari M, Hajiyeva G, Alawad AS, Kumbhari V, Khashab MA. EUS-guided gastroenterostomy is comparable to enteral stenting with fewer re-interventions in malignant gastric outlet obstruction. Surg Endosc. 2017 Jul;31(7):2946-2952. doi: 10.1007/s00464-016-5311-1. Epub 2016 Nov 10.

    PMID: 27834024BACKGROUND

  • Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.

    PMID: 20189503BACKGROUND

  • 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: 11808972BACKGROUND

MeSH Terms

Conditions

Gastric Outlet ObstructionNeoplasms

Interventions

Self Expandable Metallic Stents

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Mouen A. Khashab, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomly allocated with a 1:1 ratio to one of the study arms (EUS-GE or ES)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2017

First Posted

August 24, 2017

Study Start

October 26, 2020

Primary Completion

June 14, 2025

Study Completion

January 15, 2026

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(3)EC(1)FR(1)IN(1)IL(1)ES(1)