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Recent comparative data suggest that EUS gastroenterostomy offers more durable patency than enteral stents for treatment of malignant GOO, leading some endoscopists to suggest that EUS gastroenterostomy should be the preferred endoscopic treatment approach.
EUS gastroenterostomy and surgical gastrojejunostomy have been compared in retrospective cohort analysis, suggesting a high technical success rate a shorter hospital length of stay for the endoscopic approach [4]. Comparison of these techniques has not been reported in controlled prospective fashion. A prospective trial is necessary in order to define the optimal interventional management option for treatment of malignant GOO in the context of the contemporary and rapidly evolved range of available endoscopic and surgical treatment options.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUS Gastrojejunostomy | Active Comparator | Patient will undergo an Endoscopic Ultrasound (EUS) Gastrojejunostomy procedure |
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| Surgical Gastrojejunostomy | Active Comparator | Patient will undergo Surgical Gastrojejunostomy procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS Gastrojejunostomy | Procedure | Endoscopic Ultrasound (EUS) Gastrojejunostomy. Under live real-time EUS visualization, a solution of normal saline or water and dilute methylene blue will be infused through the nasobiliary drainage catheter to mechanically distend the small intestine and create a suitable, expanded fluid-filled target for transgastric access. Once a suitable target has been identified, a lumen apposing metal stent (LAMS) will then be deployed securely across the newly created gastroenterostomy tract. Appropriate stent placement will be confirmed. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare of restoration of oral intake following EUS versus surgical gastrojejunostomy | A GOOSS score of 0 will be defined as intolerant of oral intake, while any GOOSS score greater than 0 will be defined as tolerant of oral intake. 0: no oral intake
| 1 day post-operative |
| Compare post procedure length of hospital stay | This outcome will be measured as the length of hospital stay (in days) from study intervention to discharge. Any accrued hospital stay from admission prior to study intervention will not be included in this assessment. | 14 days post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Yachimski, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
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Due to the nature and means of access of the two interventions (one via peroral approach and one via abdominal incision) blinding of the subjects, study investigators, and treating clinicians will not be practicable short of subjecting patients to sham endoscopy and/or surgery, which we feel would be unethical.
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| Surgical Gastrojejunostomy | Procedure | Gastrojejunostomy will be performed via an open technique using an upper midline or left sub-costal incision (at the discretion of the surgeon). An antecolic, pro-peristaltic, gastrojejunostomy will be performed using one of two standard techniques: 1) hand-sewn: 2-layer anastomosis using absorbable suture or 2) stapled: single-layer anastomosis using a surgical stapler with closed staple height ranging from 1.0 - 1.5 mm and suture closure of the common enterotomy. Feeding tube placement will be at the discretion of the operating surgeon and if performed, will be performed via a Stamm technique. Abdominal fascial closure will be performed with absorbable, monofilament, suture and skin will be closed using staples or suture at the discretion of the surgeon. |
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| Gastric Outlet Obstruction Scoring System (GOOSS) | Other | A previously validated instrument for assessing tolerance of oral intake. |
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