Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy

Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy

After potential subjects are screened from the physicians’ schedules, they will be assessed for further inclusion criteria. They will be presented with the informed consent form for their review. Once they have been given the opportunity to review and ask questions, they will sign the consent form and from this point will be considered enrolled into the study.

After signing the informed consent, subjects will be randomized to one of the two cohorts in a 1:1 manner.

On the day of their assigned procedures, subjects will be asked several quality of life questionnaires to obtain a baseline status.

Data will be collected during and immediately following the procedure to assess for any possible adverse events.

Follow-up data will be completed at the following timepoints: 1-day, 2-day, 3-day, 4-day, and 7-day, 30-day, 3-month, 6-month, and 1-year post-procedure.

QOL Scoring Systems GOOSS- Gastric Outlet Obstruction Symptom Score

  • 1 Inadequate or no oral intake
  • 2 Liquids/thickened liquids
  • 3 Semisolids/ low residue
  • 4 unmodified

GFS- Gut Function Score from Lowe et al 2002

  • 0 Profuse vomiting
  • 1 Nausea and occasional vomiting
  • 2 Nausea only
  • 3 Normal gut function

Pre-Procedure Variables to Record Demographic

  • Gender
  • Weight
  • BMI
  • Cancer Type

Clinical Parameters

  • GOOSS
  • Gut Function Score
  • Karnofsky Performance Scale

Procedural Parameters

  • EUS-GJ: presence of ascites, able to pass scope beyond obstruction, use of wire to stabilize position, Length of procedure, intraprocedural AEs, Stent size used, successful completion of procedure
  • Laparoscopic GJ: presence of ascites, length of procedure, intraprocedural AEs, conversion to open GJ, successful completion of procedure

Post-procedure Hospitalization Daily Function

  • GOOSS
  • Gut Function Score
  • Time to initiation of oral intake liquids
  • Time to initiation of oral intake solids
  • Time to discharge
  • Post procedural AEs

    30 Day Outcomes

  • GOOSS
  • Gut Function Score
  • Karnofsky Performance Scale
  • Weight/BMI
  • Able to tolerate TB approved chemotherapeutic regimen

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

December 22, 2022Comments OffClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine
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