Malignant Gastric Outlet Obstruction
Conditions
Brief summary
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.
Interventions
PROCEDUREEUS Gastrojejunostomy
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.
PROCEDURESurgical Gastrojejunostomy
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.
OTHERGastric Outlet Obstruction Scoring System (GOOSS)
A previously validated instrument for assessing tolerance of oral intake.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Able to provide informed consent * Biopsy-proven cancer * Cancer without surgical resection as a curative treatment option * Clinical and radiographic presentation consistent with primary or metastatic tumor causing foregut obstruction at the level of the pylorus and/or duodenum
Exclusion criteria
* Age \<18 years * Pregnancy * Unable to provide informed consent * White Blood Count \< 3,000 * Absolute Neutrophil Count \< 1,500 * International normalized ratio \> 1.6 * Platelet count \< 100,000 * Cancer with surgical resection as a curative treatment option * Surgically altered foregut anatomy * Multifocal intestinal obstruction * Abdominal ascites prohibitive of surgical candidacy * Abdominal wall mesh prohibitive of surgical candidacy * Child's Class B or C cirrhosis * Gastroesophageal varices or known portal hypertension * Body mass index \>40
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare of restoration of oral intake following EUS versus surgical gastrojejunostomy | 1 day post-operative | 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. oral liquids only 2. soft solids 3. low residue or full diet This will be given to subjects |
| Compare post procedure length of hospital stay | 14 days post-operative | 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. |
Countries
United States
Outcome results
None listed