ClinicalTrials.Veeva

Menu

The Effect of Semi-solid Feeding After Percutaneous Endoscopic Gastrostomy (PEG) on the Incidence of Aspiration Pneumonia and Postoperative Length of Stay

H

Hiroshima Kyoritsu Hospital

Status

Completed

Conditions

Gastrostomy
Aspiration Pneumonia

Treatments

Dietary Supplement: Semi-solid feed (Terumo PG soft)
Dietary Supplement: Liquid feed (Meibalance)

Study type

Interventional

Funder types

Other

Identifiers

NCT02858596
Semi-solid trial

Details and patient eligibility

About

Percutaneous endoscopic gastrostomy (PEG) is a minimally invasive procedure for long-term enteral tube feeding in patients with insufficient oral intake. Although peristomal site infection is often noted as the most common adverse event after PEG tube placements, it is seldom life-threatening and considered a minor adverse event. Feeding-related adverse events have been identified as the main cause of death after PEG, with up to 50% of postoperative early mortality (30 days) being attributed to aspiration pneumonia. This may be related to the persistence of gastroesophageal reflux (GER) of enteral feed after gastrostomy, even though PEG have been demonstrated to be superior to nasogastric tube feeding in terms of preventing GER. It has been more than a decade since semi-solid feeds were developed as an alternative to conventional liquid feeds to prevent feeding-related adverse events. Unfortunately, there is limited published literature on this topic despite the wide usage of this feeding method in Japan. Amidst the growing popularity of this method and the introduction of National Healthcare Insurance coverage for semi-solid feed prescriptions, we initiated a semi-solid feed protocol along with our existing post-PEG feeding protocols in 2014.

Enrollment

136 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients receiving gastrostomy tube placement in our hospital for enteral nutrition.

Exclusion criteria

  • Patients receiving gastrostomy tube placement for decompression
  • Patients with no gut usage more than 2 weeks before procedure

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

136 participants in 2 patient groups, including a placebo group

Semi-solid feed group
Experimental group
Description:
Given semi-solid feed protocol
Treatment:
Dietary Supplement: Semi-solid feed (Terumo PG soft)
Liquid feed group
Placebo Comparator group
Description:
Given liquid feed protocol
Treatment:
Dietary Supplement: Liquid feed (Meibalance)

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems