UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028945 |
|---|---|
| Receipt number | R000033120 |
| Scientific Title | Multicenter phase II trial to evaluate the efficacy of Abound (nutrition product including HMB, arginine, and glutamine) on the clinical course of anastomotic leakage after gastrectomy in patients with gastric cancer |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2025/03/07 09:56:53 |
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Basic information
Public title
Multicenter phase II trial to evaluate the efficacy of Abound (nutrition product including HMB, arginine, and glutamine) on the clinical course of anastomotic leakage after gastrectomy in patients with gastric cancer
Acronym
Efficacy of Abound on the clinical course of anastomotic leakage after gastrectomy in patients with gastric cancer
Scientific Title
Multicenter phase II trial to evaluate the efficacy of Abound (nutrition product including HMB, arginine, and glutamine) on the clinical course of anastomotic leakage after gastrectomy in patients with gastric cancer
Scientific Title:Acronym
Efficacy of Abound on the clinical course of anastomotic leakage after gastrectomy in patients with gastric cancer
Region
| Japan |
Condition
Condition
Anastomotic leakage after gastrectomy for gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Abound (nutrition product including HMB, arginine, and glutamine) on the clinical course of anastomotic leakage after gastrectomy in patients with gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
The period from the diagnosis to cure of the anastomotic leakage
Key secondary outcomes
Total amount and safety of Abound administration, duration of drain placement and fasting, hospital stay, location and procedure of anastomosis, blood test and nutritional management
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Administration of Abound (nutrition product including HMB, arginine, and glutamine) twice a day for 14 days
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) Age <= 20 years
2) Performance status (PS) 0-2
3) Patients who underwent gastrectomy for gastric cancer
4) Patients who were diagnosed as an anastomotic leakage within 14 days after gastrectomy
5) Written informed consent
Key exclusion criteria
1) Severe pneumonia and sepsis
2) Leakage at the closed stump of duodenum and jejunum
3) Repeated surgery
4) Patients requiring a limiting of the water amount
5) Patients who underwent preoperative chemotherapy
6) Patients incompatible to Abound
7) Pregnancy
8) Ineligible for the study at the physician's assessment.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kodera |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery (Surgery II)
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2253
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuro |
| Middle name | |
| Last name | Kanda |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterological Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2249
Homepage URL
m-kanda@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee
Address
65 Tsurumai-cho,Showa-ku,Nagoya
Tel
052-744-2479
ethics@med.nagoya-u.ac.jp
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
| 2017 | Year | 11 | Month | 01 | 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
17
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 31 | Day |
Last modified on
| 2025 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033120
