UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054300 |
|---|---|
| Receipt number | R000061978 |
| Scientific Title | Prospective study of prehospital prehabilitation for elderly, sarcopenic, and malnourished patients in hepatobiliary and pancreatic surgery |
| Date of disclosure of the study information | 2024/05/10 |
| Last modified on | 2026/01/13 17:26:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective study of prehospital prehabilitation for elderly, sarcopenic, and malnourished patients in hepatobiliary and pancreatic surgery
Acronym
Prospective study of prehospital prehabilitation for elderly, sarcopenic, and malnourished patients in hepatobiliary and pancreatic surgery: PROPRE study
Scientific Title
Prospective study of prehospital prehabilitation for elderly, sarcopenic, and malnourished patients in hepatobiliary and pancreatic surgery
Scientific Title:Acronym
PROPRE study
Region
| Japan |
Condition
Condition
potentially resectable hepatobiliary and pancreatic cases
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the safety and effectiveness of self-prehabilitation by using the waiting period before hospitalization to perform self-prehabilitation at home, including postoperative complications, prognosis, and quality of life.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prehabilitation Achievement and Safety
Key secondary outcomes
(1) Perioperative complications (evaluated by Clavien-Dindon classification)
(2) Length of hospital stay and postoperative hospital stay
(3) Disease free survival (DFS)
(4) Over all survival (OS)
(5) Change in quality of life (EORTC-QLQ-C30, FACT-HEP)
(6) Change in depression assessment (HADS)
(7) Nutritional assessment (In Body, blood test, CT iliopsoas assessment)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Squatting, standing on one leg, and walking 4,000 to 5,000 steps per day (40 minutes) in the 2 weeks prior to admission
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) Patients clinically ill with hepatobiliary-pancreatic disease for whom surgery is contemplated.
(2) Patients over 65 years old.
(3) In addition to 2 above, all patients with possible sarcopenia will be considered regardless of age. The diagnosis of possible sarcopenia will be evaluated according to the AWGS 2019 sarcopenia diagnostic criteria as described below.
(4) Eligible surgical procedures will be as follows (all procedures will include both laparoscopic and open procedures) (a)Liver resection cases (b) Pancreatectomy
(5) Cases with PS (ECOG classification) of 0 to 1
(6) Cases in which functions of major organs (bone marrow, liver, kidney, lung, etc.) are preserved
(The following criteria are met according to laboratory values within 14 days prior to enrollment.)
White blood cell count: greater than 3,500/mm3 and less than 12,000/mm3
Neutrophil count: 2,000/mm3 or more
Hemoglobin level: 9.0 g/dl or greater
Platelet count: 100,000/mm3 or greater
Total bilirubin: 2.0 mg/dL or less*.
Patients undergoing yellowing reduction for obstructive jaundice are expected to have a level of 3.0 mg/dL or less at the time of surgery.
AST and ALT levels: 150 U/L or less
Creatinine: 1.2 mg/dl or less
(7) Cases in which oral intake is possible
(8) Patients who have given written consent to be a subject in this study
(9)Patients who are at least 20 years of age at the time of consent and have sufficient judgment to obtain consent for this study.
(10)Cases in which the subject has been fully informed of the details of the study and has given his/her written consent.
Key exclusion criteria
(1) Patients with pulmonary fibrosis or interstitial pneumonia
(2) Patients with malignant tumors that are expected to have no gross residual cancer at the time of resection.
(3) Patients with active multiple cancers.
Simultaneous overlapping cancers or disease-free period of less than 3 years. However, intraepithelial and intramucosal cancers are not included.
(4) Active infection (e.g., fever > 38.0 degrees Celsius)
(5) Patients using flucytosine, phenytoin, or warfarin
(6) Pregnant or possibly pregnant
(7) Other conditions deemed by the attending physician to be inappropriate for the safe conduct of this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Katayose |
Organization
Tohoku Medical and Pharmaceutical University Hospital
Division name
Hepatobiliary and pancreatic surgery
Zip code
983-8512
Address
1-2-1, FUkumuro, Miyaginoku, SENDAI
TEL
022-259-1221
y17.katayo@tohoku-mpu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Sakurai |
Organization
Tohoku Medical and Pharmaceutical University Hospital
Division name
Hepatobiliary and pancreatic surgery
Zip code
983-8512
Address
1-12-1, FUkumuro, Miyaginoku, SENDAI
TEL
022-259-1221
Homepage URL
h.sakurai@tohoku-mpu.ac.jp
Sponsor or person
Institute
Tohoku Medical and Pharmaceutical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Lab Budget
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
Tohoku Medical and Pharmaceutical University Hospital Clinical Research Audit Committee
Address
1-12-1, FUkumuro, Miyaginoku, SENDAI
Tel
022-259-1221
research@hosp.tohoku-mpu.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
東北医科薬科大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 01 | Day |
Last modified on
| 2026 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061978
