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Complications Associated with Primary Placement of Radiologically-Inserted Gastrostomy versus Percutaneous Endoscopic Gastrostomy for Feeding

Overview

Información sobre este estudio

The use of long-term enteral tube feeding has increased dramatically in the United States and worldwide. Radiologically-inserted gastrostomy (RIG) or percutaneous endoscopic gastrostomy (PEG) are the most common techniques used for long term enteral feeding. Gastrostomy-related complications are classified as major (peritonitis, abscess, bleeding requiring intervention/transfusion, bowel perforation, death) or minor (superficial infection, skin erosion, bleeding not requiring intervention, exit site leakage or tube complication [occluded, malpositioned/dislodged, damaged]). Not many studies have compared the outcomes and major and minor complications associated with RIG versus PEG. The primary objectives of this study are to assess pain as well as major and minor complications with gastrostomy-tube placement, comparing RIG with PEG. The secondary objectives are to compare costs associated with each technique, to compare anesthesia type used with each technique, and to assess patient quality of life before and after the procedure.

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Cannot maintain adequate nutrition by mouth

Exclusion Criteria:

  • Venting-only gastrostomy
  • Patients with ALS
  • Coagulopathy with uncorrectable INR greater than 1.5 or inability to hold anticoagulation
  • Structural abnormality that would prevent one or both techniques
    • Known severe esophageal stricture
    • Obstructing malignancy in oropharynx or esophagus before surgery or before completing a course of radiation therapythat prohibits pull-through technique
    • Neoplastic, inflammatory, or infiltrative disease of abdominal wall or gastric wall
    • Known hepatomegaly
    • Abdominal wall mesh
  • Enteric functional abnormality
    • Small bowel or colonic obstruction
    • Gastric or small bowel dysmotility
  • Active abdominal infection/peritonitis/enterocutaneous fistula
  • Ascites
  • Ventriculoperitoneal shunt
  • Inpatient status

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Melissa Neisen, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20387110

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