UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018353 |
|---|---|
| Receipt number | R000021243 |
| Scientific Title | Enteral and Parenteral Nutrition in the Conservative Treatment for gastrectomy related Pancreatic Fistula: A Randomized Clinical Trial |
| Date of disclosure of the study information | 2015/07/20 |
| Last modified on | 2016/06/01 01:55:27 |
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Basic information
Public title
Enteral and Parenteral Nutrition in the Conservative Treatment for gastrectomy related Pancreatic Fistula: A Randomized Clinical Trial
Acronym
EN vs PN in the treatment of POPF: A Randomized Clinical Trial
Scientific Title
Enteral and Parenteral Nutrition in the Conservative Treatment for gastrectomy related Pancreatic Fistula: A Randomized Clinical Trial
Scientific Title:Acronym
EN vs PN in the treatment of POPF: A Randomized Clinical Trial
Region
| Japan |
Condition
Condition
gastrectomy related Pancreatic Fistula
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to demonstrate a significant advantage in enteral nutrition compared to parenteral nutrition by multicenter phase3 study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The cure rate of pancreatic fistula within 30 postoperative day.
Key secondary outcomes
The disease duration of pancreatic fistula.
The rate of drain removal within 30 postoperative day.
The period of postoperative hospitalization.
Nutritional index during the study(body weight, serum albumin, total serum albumin, total serum cholesterol, lymphocyte count)
The incidence of adverse effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Patients will be random allocated for enteral nutrition(EN) group or parenteral nutrition(PN) group.
Interventions/Control_2
Patients who are in EN group will be inserted nasal feeding tube and feeded, and other patients who are in PN group will be inserted central venous catheter and administered total parental nutrition.
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
Gastric cancer has been diagnosed by pathological findings.
Post-gastrectomy (R0 or R1 resection) within 3-7 postoperative days (POD).
The case has been inserted drain into the abdominal cavity. The laboratory data of amylase for drain discharge after 3POD and within 1day of enrollment must be more than three times higher limit of serum amylase.
The case has been diagnosed without anastomotic leakage by CT scan or X-Ray.
Laboratory data within 3days before enrollment must be fulfilled as follows.
WBC >=3000/mm3
Hb>=8.0g/dL
Plt >=100000/mm3
T-bil<=2.0mg/dL
AST<150IU/L
ALT<150IU/L
Creatinine<=1.5 mg/dL
The case has never received radiotherapy for their abdominal cavity including other cancers.
The case signed informed consent.
Key exclusion criteria
The case with another malignant tumors.
The case are in the catecholamine-dependent shock stage.
The case are pregnant or potentially pregnant.
The doctors define as inappropriate because of severe psychosis or psychological symptom.
The case has been systemic administered steroids continually.
The case has poorly-controlled hypertension.
The case has continually administered insulin or poor-controlled diabetes mellitus.
The case has ventilator-dependent respiratory complications.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Doki |
Organization
Osaka University, Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2, Yamadaoka, Suita city, Osaka, Japan.
TEL
+81-6-6879-3251
ydoki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuji Takiguchi |
Organization
Osaka University, Graduate School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2, Yamadaoka, Suita city, Osaka, Japan.
TEL
+81-6-6879-3251
Homepage URL
stakiguchi@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Terminated
Date of protocol fixation
| 2014 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 16 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 16 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 16 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 20 | Day |
Last modified on
| 2016 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021243
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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