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

Gastrostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02858596
• Other study ID #: Semi-solid trial
• Status: Completed
• Phase: N/A
• First received: August 1, 2016
• Last updated: August 5, 2016
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Hiroshima Kyoritsu Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Gastrostomy
• Pneumonia
• Pneumonia, Aspiration

Intervention

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

• Liquid feed (Meibalance)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hiroshima Kyoritsu Hospital

References & Publications (4)

Adachi K, Furuta K, Morita T, Nakata S, Ohara S, Tanimura T, Koshino K, Miki M, Ishimura N, Inoue Y, Ryuko K, Umegae N, Ohhata S, Katoh S, Yamamoto K, Nariai Y, Hashimoto Y, Sumi A, Kawaguchi M, Kinoshita Y. Half-solidification of nutrient does not decrease gastro-esophageal reflux events in patients fed via percutaneous endoscopic gastrostomy. Clin Nutr. 2009 Dec;28(6):648-51. doi: 10.1016/j.clnu.2009.05.006. Epub 2009 Jun 5. — View Citation

Nishiwaki S, Araki H, Shirakami Y, Kawaguchi J, Kawade N, Iwashita M, Tagami A, Hatakeyama H, Hayashi T, Maeda T, Saitoh K. Inhibition of gastroesophageal reflux by semi-solid nutrients in patients with percutaneous endoscopic gastrostomy. JPEN J Parenter Enteral Nutr. 2009 Sep-Oct;33(5):513-9. doi: 10.1177/0148607108327045. Epub 2009 Jun 1. — View Citation

Shizuku T, Adachi K, Furuta K, Niigaki M, Miyaoka Y, Katoh S, Kobayashi K, Otani M, Kawashima K, Otani J, Kinoshita Y. Efficacy of half-solid nutrient for the elderly patients with percutaneous endoscopic gastrostomy. J Clin Biochem Nutr. 2011 May;48(3):226-9. doi: 10.3164/jcbn.10-108. Epub 2011 Apr 13. — View Citation

Tanishima Y, Fujita T, Suzuki Y, Kawasaki N, Nakayoshi T, Tsuiboi K, Omura N, Kashiwagi H, Yanaga K. Effects of half-solid nutrients on gastroesophageal reflux in beagle dogs with or without cardioplasty and intrathoracic cardiopexy. J Surg Res. 2010 Jun 15;161(2):272-7. doi: 10.1016/j.jss.2009.03.025. Epub 2009 Apr 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of aspiration pneumonia		through study completion, average 90 days postoperation	No
Secondary	Postoperative length of stay		through study completion, average 90 days postoperation	No