Complications Associated with Primary Placement of Radiologically-Inserted Gastrostomy versus Percutaneous Endoscopic Gastrostomy for Feeding
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-010077
NCT ID: NCT05173935
Sponsor Protocol Number: 16-010077
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Melissa Neisen, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available