Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06567691
Status
Enrolling By Invitation

Conditions

  • Malignant Gastric Outlet Obstruction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.
  • Gastric Outlet Obstruction Scoring System (GOOSS) — OTHER
    A previously validated instrument for assessing tolerance of oral intake.

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Aug 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: EUS Gastrojejunostomy
    Patient will undergo an Endoscopic Ultrasound (EUS) Gastrojejunostomy procedure
  • Active Comparator: Surgical Gastrojejunostomy
    Patient will undergo Surgical Gastrojejunostomy procedure.

Primary Outcome Measure

Compare of restoration of oral intake following EUS versus surgical gastrojejunostomy [ Time Frame: 1 day post-operative ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37212-

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