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Enrolling by Invitation

NCT Number: NCT06567691

Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

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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Key information

Conditions

Malignant Gastric Outlet Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Compare of restoration of oral intake following EUS versus surgical gastrojejunostomy

    Time frame: 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

    • oral liquids only
    • soft solids
    • low residue or full diet This will be given to subjects

  2. Compare post procedure length of hospital stay

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 23, 2024
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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