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

Overview

About this study

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.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Melissa Neisen, M.D.

Open for enrollment

Contact information:

Manpreet Mundi M.D.

(507)284-4080

Mundi.Manpreet@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

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Supplemental Study Information

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