UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047828 |
|---|---|
| Receipt number | R000054526 |
| Scientific Title | A phase II random trial of feeding gastrostomy for preventing weight loss after esophagectomy |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2023/05/23 18:52:48 |
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Basic information
Public title
A phase II random trial of feeding gastrostomy for preventing weight loss after esophagectomy
Acronym
A random trial of feeding gastrostomy after esophagectomy
Scientific Title
A phase II random trial of feeding gastrostomy for preventing weight loss after esophagectomy
Scientific Title:Acronym
A random trial of feeding gastrostomy after esophagectomy
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We are planning to evaluate the effect of feeding gastrostomy after esophagectomy for preventing weight loss.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight loss rate three months after esophagectomy
Key secondary outcomes
weight loss rate at six month after esophagectomy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Insertion of feeding gastrostomy at esophagectomy and intervention of 900 kcal enteral feeding
Interventions/Control_2
Nothing
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
| Not applicable |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically diagnosed as thoracic esophageal cancer.
2) Clinically, radical resection is possible.
3) The age is 75 years or younger.
4) Performance status is 0.
5) Gastric tube reconstruction is planned.
6) The patient has given written consent to participate in the study.
Key exclusion criteria
1) BMI of 30 or higher.
2) Lactose intolerance and milk allergy.
3) History of radiation therapy.
4) Active double cancer
5) Infectious disease that requires systemic treatment.
6) Severe mental illness.
7) Systemic administration of steroids or immunosuppressive drugs.
8) Uncontrolled diabetes (HbA1c: 8 or more).
9) Judgement by the attending physician.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Takushi |
| Middle name | |
| Last name | Yasuda |
Organization
Kindai University Faculty of Medicine
Division name
Surgery
Zip code
589-8511
Address
Osaka-Sayama Ono Higashi 377-2, Osaka, Japan
TEL
0723660221
osashiraishi@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Shiraishi |
Organization
Kindai University Faculty of Medicine
Division name
Surgery
Zip code
599-8511
Address
Osaka-Sayama Ono Higashi 377-2, Osaka, Japan
TEL
0723660221
Homepage URL
osashiraishi@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Faculty of Medicine, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Kindai University Faculty of Medicine, Department of Surgery
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
Kindai University Faculty of Medicine
Address
Osaka-Sayama Ono Higashi 377-2, Osaka, Japan
Tel
0723660221
zizen@med.kindai.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
| 2022 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 22 | Day |
Last modified on
| 2023 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054526
