UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031294
Receipt number R000035725
Scientific Title Effects of differences in nutritional management after percutaneous endoscopic gastrostomy (PEG) on postoperative pneumonia: A retrospective analysis
Date of disclosure of the study information 2018/03/01
Last modified on 2018/12/19 14:40:31

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Basic information

Public title

Effects of differences in nutritional management after percutaneous endoscopic gastrostomy (PEG) on postoperative pneumonia: A retrospective analysis

Acronym

Effects of nutritional management after PEG on pneumonia

Scientific Title

Effects of differences in nutritional management after percutaneous endoscopic gastrostomy (PEG) on postoperative pneumonia: A retrospective analysis

Scientific Title:Acronym

Effects of nutritional management after PEG on pneumonia

Region

Japan


Condition

Condition

Patients who underwent PEG

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of differences in postoperative nutritional management on incidence of pneumonia after PEG.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Incidence of postoperative pneumonia (within 14 days after PEG)

Key secondary outcomes

(1) Incidence of leakage of nutritional formula from fistula (within 14 days after PEG)
(2) Incidence of fistula infection (within 14 days after PEG)
(3) Mortality rate (within 30 days after PEG)


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patients who underwent PEG in department of gastroenterology, Sapporo Kiyota Hospital from March 1999 to March 2014
(2) Patients aged 20 years or older

Key exclusion criteria

(1) Patients who were not received contrast radiography via the gastrostomy within 2 days after PEG
(2) Patients who underwent PEG in order to decompress stomach

Target sample size

350


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuro Okamoto

Organization

Sapporo Kiyota Hospital

Division name

Department of Gastroenterology

Zip code


Address

1-1-1-1 Shinei, Kiyota-ku, Sapporo Hokkaido

TEL

011-883-6111

Email

gofightersgo@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Satoru Kamoshita

Organization

Otsuka Pharmaceutical Factory, Inc.

Division name

Applied Clinical Development Department

Zip code


Address

2-9 Kanda Tsukasamachi, Chiyoda-ku Tokyo

TEL

03-5217-5954

Homepage URL


Email

kamoshitas@otsuka.jp


Sponsor or person

Institute

Sapporo Kiyota Hospital

Institute

Department

Personal name



Funding Source

Organization

Otsuka Pharmaceutical Factory, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Rumoi Municipal Hospital
Otsuka Pharmaceutical Factory, Inc.
EN Otsuka Pharmaceutical Co., Ltd.

Name of secondary funder(s)

EN Otsuka Pharmaceutical Co., Ltd.


IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

札幌清田病院(北海道)


Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Primary outcome
The incidence of postoperative pneumonia (within 14 days after PEG) was 20.8% (31/149) in period I, 7.8% (5/64) in period II and 10.2% (16/157) in period III. The odds ratio (95% confidence interval) of the event was 3.10 (1.15-8.38) for period I vs. II, 2.32 (1.21-4.44) for period I vs. III, 0.75 (0.26 - 2.13) for period II vs. III.

Secondary outcomes
The mortality rate (within 30 days after PEG) was 2.0% (3/149) in period I, 0.0% (0/64) in period II and 0.6% (1/157) in period III. The incidence of leakage of nutritional formula from fistula (within 14 days after PEG) was 6.0% (9/149) in period I, 1.6% (1/64) in period II and 1.9% (3/157) in period III. The incidence of fistula infection (within 14 days after PEG) was 28.2% (42/149) in period I, 17.2% (11/64) in period II and 20% (20/157) in period III.

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 01 Month 23 Day

Date of IRB


Anticipated trial start date

2018 Year 01 Month 23 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2018 Year 04 Month 13 Day


Other

Other related information

Study design:
Single center retrospective observational study

Creation of dataset:
The data set should include patient backgrounds, postoperative complications and PEG-related adverse events collected from the medical record.

Study groups:
Patients are divided into three groups based on their treatment periods.
Period I (from March 1999 to June 2005): All patients received enteral formula after PEG.
Period II (from November 2005 to May 2007): Patients with gastroesophageal reflux revealed by contrast radiography via the gastrostomy after PEG received semi-solid enteral formula. Patients without gastroesophageal reflux revealed by contrast radiography via the gastrostomy after PEG received enteral formula.
Period III (from April 2010 to March 2014): All patients received semi-solid enteral formula after PEG.

Statistical analysis:
The incidence of postoperative pneumonia, leakage of nutritional formula, fistula infection, and mortality are compared between period I and II, I and III, and II and III. Logistic regression analysis is used to calculate odds ratio and 95% confidence interval.


Management information

Registered date

2018 Year 02 Month 14 Day

Last modified on

2018 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035725


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name