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 2022/09/04 15:22:56

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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

Email

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


Email

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

Email

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


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

Preinitiation

Date of protocol fixation

2017 Year 08 Month 31 Day

Date of IRB


Anticipated trial start date

2017 Year 11 Month 01 Day

Last follow-up date

2025 Year 06 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

2022 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033120


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name