UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059507 |
|---|---|
| Receipt number | R000068069 |
| Scientific Title | Impact of a Specialized Multidisciplinary Intervention on Outcomes in Elderly Patients Undergoing Pancreaticoduodenectomy |
| Date of disclosure of the study information | 2025/10/24 |
| Last modified on | 2025/10/22 22:06:06 |
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Basic information
Public title
Impact of a Specialized Multidisciplinary Intervention on Outcomes in Elderly Patients Undergoing Pancreaticoduodenectomy
Acronym
Impact of Multidisciplinary Intervention on Outcomes in Elderly Patients Undergoing Pancreaticoduodenectomy
Scientific Title
Impact of a Specialized Multidisciplinary Intervention on Outcomes in Elderly Patients Undergoing Pancreaticoduodenectomy
Scientific Title:Acronym
Impact of Multidisciplinary Intervention on Outcomes in Elderly Patients Undergoing Pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
Diseases Indicated for Pancreaticoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Although the attending physicians had previously provided explanations regarding the importance of nutrition and exercise, direct preoperative interventions by dietitians and physical therapists had not been implemented. Therefore, this study aims to examine whether direct preoperative interventions by specialized multidisciplinary professionals in nutritional management and prehabilitation improve surgical outcomes in elderly patients undergoing pancreaticoduodenectomy (PD). We hypothesize that identifying the significance of active, direct multidisciplinary involvement from the preoperative phase will contribute to improving the safety of PD in high-risk elderly patients.
If the results of this study demonstrate better outcomes in the group receiving active, direct multidisciplinary interventions before surgery, it will confirm the clinical value of specialized multidisciplinary involvement. Conversely, if no significant difference is observed between the intervention and non-intervention groups, it will suggest that frequent preoperative counseling by dietitians and physical therapists may not be necessary and could represent an inefficient use of medical resources.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative complication rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Once the diagnosis is established and surgery is scheduled, patients in Group A will receive direct preoperative interventions from specialized professionals-dietitians and physical therapists-using our institution's original educational booklet, "Exercise, Nutrition, and Diabetes Handbook for Biliary and Pancreatic Diseases". For nutritional therapy, dietitians will provide individualized dietary counseling with a target protein intake of 1.5 g per ideal body weight (IBW) per day. If dietary intake alone is insufficient to meet this target, patients will be instructed to supplement with one 250 mL bottle of an enteral nutritional formula (ENEVO, 0.83 yen/mL) daily. For exercise therapy, physical therapists will instruct patients to perform the following exercises: (1) toe raises, (2) knee bends, (3) abdominal curl-ups ("looking at the navel"), and (4) forward lunges-15 repetitions per set, twice daily, in addition to walking 8,000 steps per day. In Group A, compliance with nutritional and exercise interventions will be reviewed weekly through face-to-face interviews, and additional counseling will be provided as necessary. These interventions will be implemented from the time the surgical indication is confirmed until immediately before surgery.
Interventions/Control_2
In Group B, the handbook will not be used; instead, patients will receive only conventional nutritional and exercise guidance provided by their attending surgeons.
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients scheduled to undergo pancreaticoduodenectomy in the Department of Gastrointestinal and General Surgery, St. Marianna University Hospital.
2) Patients aged 70 years or older at the time of obtaining informed consent.
3) Patients who are able to walk without assistive devices.
4) Patients who have received a full explanation of the study, fully understood the content, and voluntarily provided written informed consent to participate.
Key exclusion criteria
1) Patients for whom preoperative nutritional and exercise therapy is difficult (including patients with a preoperative waiting period of less than 3 weeks)
2) Patients undergoing resection involving multiple organs
3) Patients with metallic implants or tattoos in the body
4) Patients with concomitant psychiatric disorders
5) Patients for whom informed consent cannot be obtained
6) Other patients deemed unsuitable as subjects by the principal (or sub-investigator)
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Shinjiro |
| Middle name | |
| Last name | Kobayashi |
Organization
St. Marianna University School of Medicine
Division name
Department of Gastroenterological and General Surgery
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
044-977-8111
saori.umezawa@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Umezawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Gastroenterological and General Surgery
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
0449778111
Homepage URL
saori.umezawa@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University 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
Medical Ethics Committee, Clinical Research Section at St. Marianna University
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
Tel
044-977-8111
k-sienbu.mail@marianna-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
| 2025 | Year | 10 | Month | 24 | 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 | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2029 | Year | 12 | 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
| 2025 | Year | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068069
