EUS-GE vs ES for Palliation of GOO
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/15/2018 |
| Start Date: | March 2019 |
| End Date: | October 2020 |
| Contact: | Mouen A. Khashab, MD |
| Email: | mkhasha1@jhmi.edu |
| Phone: | 443-509-3388 |
EUS-guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: A Randomized Clinical Trial
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).
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).
In recent years, Enteral Stenting (ES) has commonly been used as the first line management of
unresectable malignant gastric outlet obstruction. On the other hand, Endoscopic
ultrasonography-guided gastroenterostomy (EUS-GE) is the most recently described technique
for palliation of malignant GOO, which has the theoretical potential to minimize the risk for
stent occlusion while maintaining the less invasive endoscopic approach. This novel
endoscopic treatment entails creating a gastroenterostomy under EUS-guidance thereby
bypassing the occluded lumen. This endoscopic technique has been performed to treat patients
with GOO since 2014, and recent retrospective studies have shown that EUS-GE was comparable
to ES in terms of efficacy and safety; however, EUS-GE was associated with a significantly
decreased risk of recurrent GOO and reinterventions.
Based on the investigator's clinical experience for the last three years and the
above-mentioned study results, the goal of this study is to prospectively compare EUS-GE with
ES in the management of unresectable malignant gastric outlet obstruction. The investigators
hypothesize that EUS-GE is associated with comparable technical and clinical success and
safety profile while requiring fewer re-interventions.
unresectable malignant gastric outlet obstruction. On the other hand, Endoscopic
ultrasonography-guided gastroenterostomy (EUS-GE) is the most recently described technique
for palliation of malignant GOO, which has the theoretical potential to minimize the risk for
stent occlusion while maintaining the less invasive endoscopic approach. This novel
endoscopic treatment entails creating a gastroenterostomy under EUS-guidance thereby
bypassing the occluded lumen. This endoscopic technique has been performed to treat patients
with GOO since 2014, and recent retrospective studies have shown that EUS-GE was comparable
to ES in terms of efficacy and safety; however, EUS-GE was associated with a significantly
decreased risk of recurrent GOO and reinterventions.
Based on the investigator's clinical experience for the last three years and the
above-mentioned study results, the goal of this study is to prospectively compare EUS-GE with
ES in the management of unresectable malignant gastric outlet obstruction. The investigators
hypothesize that EUS-GE is associated with comparable technical and clinical success and
safety profile while requiring fewer re-interventions.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
We found this trial at
2
sites
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