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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031294
Receipt No. 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

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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
Institute Sapporo Kiyota Hospital
Institute
Department

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
URL(English) https://upload.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


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