Deglutition DisordersNCT02512224

Comparison of Outcomes Between Parenteral and Enteral Nutrition

An observational study of Deglutition Disorders, run by Tokyo University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Short-term outcomes of parenteral and enteral nutrition for patients unable to eat normally were compared and analyzed. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Deglutition Disorders
What is being tested?: Parenteral nutrition and Enteral nutrition
Type of treatment: Medical device
How many people: 5,824 participants
Where: No sites listed yet
Study dates: Apr 2012to Dec 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: For this study, the investigators used the Japanese Diagnosis Procedure Combination database, the details of which have been described elsewhere. The database includes administrative claims and discharge abstract data. In 2012, these data were collected for about seven million inpatients from 1,057 participating hospitals across Japan, which amounted to about half of the acute-care hospitalizations in the country.

Who may be able to join

investigators selected participants aged 20 years or older who had undergone either parenteral nutrition by central venous port insertion or enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013. Patients who received both gastrostomy and central venous port insertion were assigned to the gastrostomy group.

Who cannot join

investigators excluded participants who had been diagnosed with cancer.

About this study

Official title: Comparison of Short-term Mortality and Morbidity Between Parenteral and Enteral Nutrition for Adults Without Cancer: a Propensity-matched Analysis Using a National Inpatient Database

Short-term outcomes of parenteral and enteral nutrition for patients unable to eat normally were compared and analyzed.

Read the detailed description

Data were acquired from patients selected from a national inpatient database covering 1,057 hospitals in Japan. Participants had received artificial nutrition between April 2012 and March 2013, were 20 years or older, and did not have cancer. Participants were grouped into two groups: those receiving parenteral nutrition and those receiving enteral nutrition. The investigators performed one-to-one propensity-score matching between the groups. The primary outcome measurements were mortality rates at 30 and 90 days after the start of the procedure. The secondary outcomes were post-procedural complications, pneumonia, and sepsis. The investigators analyzed survival length of stay after the procedure using a Cox proportional hazards model.

Conditions: Deglutition Disorders
Being tested: Parenteral nutrition, Enteral nutrition
Keywords: parenteral nutrition, enteral nutrition
Medical subject headings: Deglutition Disorders, Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Parenteral nutritionDevice
Participants are retrospectively selected with propensity score matching
Enteral nutritionDevice
Participants are retrospectively selected with propensity score matching

Study groups in NCT02512224
Study group	Role	What they receive
Parenteral nutrition		investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013. Receives: Device: Parenteral nutrition
Enteral nutrition		investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013. Receives: Device: Enteral nutrition

What is being measured

The primary outcome is the main question the study is designed to answer.

Mortality Calculated From Outcome Section From DPC Database at 90 Days
Measured: 90 days after the start of the procedure

Secondary outcomes (5)

Post-procedural Pneumonia
Measured: the incidence of post-procedural pneumonia occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure.
Post-procedural Sepsis
Measured: the incidence of post-procedural sepsis occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure.
Re-admission 30 Days
Measured: re-admission within 30 days of discharge.
Mortality Calculated From Outcome Section From DPC Database at 14 Days
Measured: 14 days after the start of the procedure
Mortality Calculated From Outcome Section From DPC Database at 30 Days
Measured: 30 days after the start of the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Dec 2014

First posted30 Jul 2015 (estimated)
Study startApr 2012
Primary completionMar 2013
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Deglutition DisordersStudies 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: Observational
Time perspective: Retrospective
Enrolment: 5,824 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02512224
Sponsor's protocol ID: MHLW H26-Policy-011
Other IDs: MHLW H26-Special-047, NCGG 25-11
Status last verified: Sep 2015
First submitted: 28 Jul 2015
Last updated: 30 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Tamiya H, Yasunaga H, Matusi H, Fushimi K, Akishita M, Ogawa S. Comparison of short-term mortality and morbidity between parenteral and enteral nutrition for adults without cancer: a propensity-matched analysis using a national inpatient database. Am J Clin Nutr. 2015 Nov;102(5):1222-8. doi: 10.3945/ajcn.115.111831. Epub 2015 Oct 7.
PubMed 26447149

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
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Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
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The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
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taVNS in Infants Severe Dysphagia
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Active, not recruitingObservational study
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All Deglutition Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Short-term Mortality and Morbidity Between Parenteral and Enteral Nutrition for Adults Without Cancer: a Propensity-matched Analysis Using a National Inpatient Database
ClinicalTrials.gov ID: NCT02512224
Acronym / sponsor ID: MHLW H26-Policy-011
Conditions: Deglutition Disorders
Keywords: parenteral nutrition, enteral nutrition
Study type: Observational
Recruitment status: Completed
Enrolment: 5,824 participants (actual)
Lead sponsor: Tokyo UniversityUniversity, hospital or other
Study start: Apr 2012
Primary completion: Mar 2013 (actual)
Study completion: Dec 2014 (actual)
First posted: 30 Jul 2015 (estimated)
Results: Posted 10 Sep 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Short-term outcomes of parenteral and enteral nutrition for patients unable to eat normally were compared and analyzed.

Detailed description

Study design

Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Parenteral nutrition	–	Device: Parenteral nutritioninvestigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.
Enteral nutrition	–	Device: Enteral nutritioninvestigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: For this study, the investigators used the Japanese Diagnosis Procedure Combination database, the details of which have been described elsewhere. The database includes administrative claims and discharge abstract data. In 2012, these data were collected for about seven million inpatients from 1,057 participating hospitals across Japan, which amounted to about half of the acute-care hospitalizations in the country.

Key inclusion criteria (1 listed)

investigators selected participants aged 20 years or older who had undergone either parenteral nutrition by central venous port insertion or enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013. Patients who received both gastrostomy and central venous port insertion were assigned to the gastrostomy group.

Key exclusion criteria (1 listed)

investigators excluded participants who had been diagnosed with cancer.

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
Parenteral nutritionParticipants are retrospectively selected with propensity score matching	Device	Parenteral nutrition
Enteral nutritionParticipants are retrospectively selected with propensity score matching	Device	Enteral nutrition

Primary outcome

Mortality Calculated From Outcome Section From DPC Database at 90 Days
Time frame: 90 days after the start of the procedure

5 secondary outcomes

Post-procedural Pneumonia
Time frame: the incidence of post-procedural pneumonia occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure.
Post-procedural Sepsis
Time frame: the incidence of post-procedural sepsis occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure.
Re-admission 30 Days
Time frame: re-admission within 30 days of discharge.
Mortality Calculated From Outcome Section From DPC Database at 14 Days
Time frame: 14 days after the start of the procedure
Mortality Calculated From Outcome Section From DPC Database at 30 Days
Time frame: 30 days after the start of the procedure

Results and safety

Results posted to the registry on 10 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Parenteral Nutrition	2,912	2,912
Enteral Nutrition	2,912	2,912

Primary outcome: Mortality Calculated From Outcome Section From DPC Database at 90 Days

Time frame: 90 days after the start of the procedure. Number. Unit: Participants

Measure	Parenteral Nutrition n = 2912	Enteral Nutrition n = 2912
Value	359	287

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Parenteral Nutrition	0 of 2,912 (0%)	0 of 2,912 (0%)	Not reported
Enteral Nutrition	0 of 2,912 (0%)	0 of 2,912 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26447149Tamiya H, Yasunaga H, Matusi H, Fushimi K, Akishita M, Ogawa S. Comparison of short-term mortality and morbidity between parenteral and enteral nutrition for adults without cancer: a propensity-matched analysis using a national inpatient database. Am J Clin Nutr. 2015 Nov;102(5):1222-8. doi: 10.3945/ajcn.115.111831. Epub 2015 Oct 7.

Related trials for Deglutition Disorders

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
Early Feeding TL Trial
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Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux

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.

Sumito Ogawa, MD. PhD. principal investigator

Tokyo University

Questions about this trial

What is this clinical trial studying?

An observational study of Deglutition Disorders, run by Tokyo University.

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 1 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 30 Sep 2015. 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. 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?

Yes. Results are posted in the registry (first posted 10 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mortality Calculated From Outcome Section From DPC Database at 90 Days (time frame: 90 days after the start of the procedure). 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 NCT02512224, which also lists 1 linked publication.

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 30 Sep 2015.