UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059435 |
|---|---|
| Receipt number | R000067960 |
| Scientific Title | Examination of clinical utility of a novel formula containing fermented milk for early enteral nutrition after surgery for malignant esophageal tumors |
| Date of disclosure of the study information | 2025/10/16 |
| Last modified on | 2025/10/16 18:49:34 |
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Basic information
Public title
Examination of clinical utility of a novel formula containing fermented milk for early enteral nutrition after surgery for malignant esophageal tumors
Acronym
Examination of clinical utility of a novel formula containing fermented milk for early enteral nutrition after surgery for malignant esophageal tumors
Scientific Title
Examination of clinical utility of a novel formula containing fermented milk for early enteral nutrition after surgery for malignant esophageal tumors
Scientific Title:Acronym
Examination of clinical utility of a novel formula containing fermented milk for early enteral nutrition after surgery for malignant esophageal tumors
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively observe the effects of early enteral nutrition using a fomula containing fermented milk on abdominal symptom, infectious complications, and gut/oral microbiota in patients after surgery for malignant esophageal tumors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Incidence of postoperative infectious complications (pneumonia, suture dehiscence, wound infection) of Clavien-Dindo Grade 2 or higher
2) Incidence of nausea/vomiting, abdominal distension, and diarrhea of Clavien-Dindo grade 2 or higher
Key secondary outcomes
1) Maximum and minimum blood glucose levels from postoperative day 1 ro postoperative day 3 (POD1 to POD3)
2) Maximum daily bowel movements from POD1 to discharge
3) Maximum daily Bristol Stool Scale from POD1 to discharge
4) Measurements of blood inflammatory markers (CRP, IL-6) and intestinal barrier markers (LBP, Zonulin), and oral and fecal microbiota at three time points: preoperatively, postoperatively, and at discharge
5) Pathological findings
6) Prognosis (presence or absence of survival and recurrence, postoperative survival period and disease-free survival)
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients aged between 20 and 89 years old at the time of obtaining consent or day of surgery
2. Patients diagnosed with malignant tumor arising in the esophagus or esophagogastric junction, regardless of histological type
3. Patients who underwent subtotal esophagectomy based on the diagnosis in 2), regardless of preoperative treatment
4. Patients who received thoracoscopic and laparoscopic esophagectomy (including robot-assisted surgery), and who underwent one-stage gastric conduit reconstruction. Patients will be excluded if they meet any of the following apply
(i) Patients who underwent two-stage surgery.
(ii) Patients who underwent gastrointestinal reconstruction using grafts other than gastric conduit (such as colonic of jejunal reconstruction).
(iii) Patients who were converted to thoractomy or laparotomy during surgery.
(iv) Patients whose surgery was cancelled for any reason.
(v) Patients who underwent jejunostomy.
Key exclusion criteria
1. Patients with a history of abdominal surgery accompanied with excision of gastrointestinal tract.
2. Patients with a past histroy of inflammatory bowel disease.
3. Patients whose HbA1c value was above 7.0% at the most recent outpatient visit before surgery.
4. Patients who received antibiotic treatment within one month before surgery.
5. Patients who underwent enteral nutrition of central veous nutrition within one month berfore surgery.
6. Patients who developed infectious enteritis after surgery.
7. Patients who underwent reoperation.
8. Patients who could not start enteral nutrition for any reason.
9. Patients who were deemed inappropriate by the principal investigator or co-investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Daiko |
Organization
National Cancer Center Hospital
Division name
Department of Esophageal Surgery
Zip code
104-0045
Address
5-5-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
hdaiko@ncc.go.jp
Public contact
Name of contact person
| 1st name | Ryoko |
| Middle name | |
| Last name | Nozaki |
Organization
National Cancer Center Hospital
Division name
Department of Esophageal Surgery
Zip code
104-0045
Address
5-5-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
rynozak@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Meiji Holdings Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee at National Cancer Center
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
irst@ml.res.ncc.go.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
国立がん研究センター中央病院（東京都）/ National Cancer Center Hospital
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 16 | 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
| 2025 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will prospectively observe the effects of administering a novel formula containing fermented milk as early enteral nutrition in postoperative esophageal cancer patients on their abdominal symptoms, the incidence of infectious complications, and gut microbiota.
Management information
Registered date
| 2025 | Year | 10 | Month | 16 | Day |
Last modified on
| 2025 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067960
