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Enrolling by invitation NCT06567691

Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

No phase Interventional Malignant Gastric Outlet Obstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EUS Gastrojejunostomy, Surgical Gastrojejunostomy, Gastric Outlet Obstruction Scoring System (GOOSS).
Who it may be relevant to
Registry conditions: Malignant Gastric Outlet Obstruction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy for Treatment of Malignant Gastric Outlet Obstruction: a Randomized Controlled Trial

Overview

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

  • Procedure EUS 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. Appropriat
  • Procedure Surgical 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
  • Other Gastric Outlet Obstruction Scoring System (GOOSS)
    A previously validated instrument for assessing tolerance of oral intake.

Primary outcome measures

  • Compare of restoration of oral intake following EUS versus surgical gastrojejunostomy [Time frame: 1 day post-operative]
  • Compare post procedure length of hospital stay [Time frame: 14 days post-operative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT06567691 · 240747

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗