GastrostomyNCT02858596
The Effect of Semi-solid Feeding After Percutaneous Endoscopic Gastrostomy (PEG) on the Incidence of Aspiration Pneumonia and Postoperative Length of Stay
A study testing Semi-solid feed (Terumo PG soft) and Liquid feed (Meibalance) in people with Gastrostomy and Aspiration Pneumonia, run by Hiroshima Kyoritsu Hospital.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrostomy, Aspiration Pneumonia
- What is being tested?
- Semi-solid feed (Terumo PG soft) and Liquid feed (Meibalance)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients receiving gastrostomy tube placement in our hospital for enteral nutrition.
Who cannot join
- Patients receiving gastrostomy tube placement for decompression
- Patients with no gut usage more than 2 weeks before procedure
About this study
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
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.
- Conditions
- Gastrostomy, Aspiration Pneumonia
- Being tested
- Semi-solid feed (Terumo PG soft), Liquid feed (Meibalance)
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-solid feed (Terumo PG soft)Dietary supplement
Liquid feed (Meibalance)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Semi-solid feed group | Experimental | Given semi-solid feed protocol Receives: Dietary Supplement: Semi-solid feed (Terumo PG soft) |
| Liquid feed group | Placebo comparator | Given liquid feed protocol Receives: Dietary Supplement: Liquid feed (Meibalance) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of aspiration pneumonia
Measured: through study completion, average 90 days postoperation
Secondary outcomes (1)
Postoperative length of stay
Measured: through study completion, average 90 days postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GastrostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hiroshima Kyoritsu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong Toh Yoon, Hiroshima Kyoritsu Hospital
- Investigators
- Toh Yoon Wong, MD, Principal investigator, Hiroshima Kyoritsu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858596
- Sponsor's protocol ID
- Semi-solid trial
- Status last verified
- Aug 2016
- First submitted
- 1 Aug 2016
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 21562643Adachi 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.
PubMed 19501431Nishiwaki 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.
PubMed 19487579Tanishima 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.
PubMed 19577758
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02858596
- Acronym / sponsor ID
- Semi-solid trial
- Conditions
- Gastrostomy, Aspiration Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Hiroshima Kyoritsu HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semi-solid feed group | Experimental | Dietary Supplement: Semi-solid feed (Terumo PG soft)Given semi-solid feed protocol |
| Liquid feed group | Placebo comparator | Dietary Supplement: Liquid feed (Meibalance)Given liquid feed protocol |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving gastrostomy tube placement in our hospital for enteral nutrition.
Key exclusion criteria (2 listed)
- Patients receiving gastrostomy tube placement for decompression
- Patients with no gut usage more than 2 weeks before procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-solid feed (Terumo PG soft) | Dietary supplement | Semi-solid feed group |
| Liquid feed (Meibalance) | Dietary supplement | Liquid feed group |
Primary outcome
Incidence of aspiration pneumonia
Time frame: through study completion, average 90 days postoperation
1 secondary outcome
Postoperative length of stay
Time frame: through study completion, average 90 days postoperation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Background: PubMed 21562643Shizuku 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.
- Background: PubMed 19501431Adachi 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.
- Background: PubMed 19487579Nishiwaki 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.
- Background: PubMed 19577758Tanishima 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toh Yoon Wong, MD principal investigator
Hiroshima Kyoritsu Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Semi-solid feed (Terumo PG soft) and Liquid feed (Meibalance) in people with Gastrostomy and Aspiration Pneumonia, run by Hiroshima Kyoritsu Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of aspiration pneumonia (time frame: through study completion, average 90 days postoperation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02858596, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.