UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053268 |
|---|---|
| Receipt number | R000060786 |
| Scientific Title | Evaluation of the pre- and post-operative health status of hepato-biliary-pancreatic surgery using EQ-5D-5L as a patient-reported outcome measure |
| Date of disclosure of the study information | 2024/01/05 |
| Last modified on | 2025/01/08 16:30:13 |
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Basic information
Public title
Evaluation of the pre- and post-operative health status of hepato-biliary-pancreatic surgery
Acronym
Evaluation of the pre- and post-operative health status of hepato-biliary-pancreatic surgery
Scientific Title
Evaluation of the pre- and post-operative health status of hepato-biliary-pancreatic surgery using EQ-5D-5L as a patient-reported outcome measure
Scientific Title:Acronym
Evaluation of the pre- and post-operative health status of hepato-biliary-pancreatic surgery using EQ-5D-5L as a patient-reported outcome measure
Region
| Japan |
Condition
Condition
Hepatobiliary and pancreatic disorders for which hepatectomy, pancreaticoduodenectomy or distal pancreatectomy are indicated
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Currently, minimally invasive surgery (MIS) is gaining widespread acceptance in the field of hepato-biliary-pancreatic (HBP) surgery. There are many acknowledged benefits of MIS including smaller incisions leading to shorter postoperative hospital stay and improved precision of surgical procedures.
However, these advantages are presented just by healthcare givers and may not necessarily reflect true benefits for patients. To assess whether MIS genuinely benefits patients, it is very important to use Patient-Reported Outcome Measures (PROMs). The EQ-5D-5L questionnaire is a widely used method of PROMs to quantify and assess the Quality of Life (QOL), which is also utilized in the field of healthcare policy as an indicator for determining the cost-effectiveness of medical interventions. While there have been studies using the EQ-5D-5L questionnaire to investigate postoperative QOL after MIS, there are few studies in the HBP field, which is just focusing on distal pancreatectomy. As MIS is expected to continue expanding, it is essential to judge whether it genuinely benefits patients. Therefore, in this study, we aim to conduct the first-ever postoperative QOL survey using the EQ-5D-5L questionnaire in the field of HBP in Japan, which is not limited to distal pancreatectomy but also includes pancreaticoduodenectomy and liver resection procedures.
Additionally, we incorporate the evaluation of patient physical activity using an activity tracker into this study. If patients who answer "I have no problems walking about" in the EQ-5D-5L questionnaire are shown to actually have high levels of physical activity, it would strengthen the credibility of the questionnaire survey. Furthermore, if it can be demonstrated that the MIS group has significantly higher levels of physical activity compared to the open surgery group in the early postoperative period, this in itself would provide evidence that MIS improves postoperative patient QOL.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The EQ-5D index value of the patients receiving hepatectomy, pancreaticoduodenectomy and distal pancreatectomy on postoperative day 5, 21-28, 50-70
Key secondary outcomes
The distribution of responses to each question on the EQ-5D-5L questionnaire for patients receiving hepatectomy, pancreaticoduodenectomy and distal pancreatectomy on postoperative day 5, 21-28, 50-70, patient physical activity using an activity tracker
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 and above who undergo hepatectomy, pancreaticoduodenectomy, and pancreatectomy between the trial start date and December 31, 2025 at the Department of Hepato-Biliary-Pancreatic and Transplant Surgery at the University of Tokyo Hospital, as well as the surgery department at affiliated hospital.
Key exclusion criteria
Patients aged 17 and below. Patients who do not consent to participation in this study. Patients undergoing hepatopancreatoduodenectomy. Patients undergoing hepatectomy with extrahepatic bile duct resection.Patients requiring reoperation due to postoperative complications. Distal pancreatectomy with combined resection of the celiac artery trunk. Cases deemed difficult to resect intraoperatively.
Cases involving combined resection of other organs.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Hasegawa |
Organization
The university of Tokyo hospital
Division name
Hepato-biliary-Pancreatic Surgery Division and Artificial Organ and Transplantation Division
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
hasegawa-secretary@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kano |
Organization
The university of Tokyo hospital
Division name
Hepato-biliary-Pancreatic Surgery Division and Artificial Organ and Transplantation Division
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
takeshi.kano0707@gmail.com
Sponsor or person
Institute
The university of Tokyo hospital
Institute
Department
Personal name
Funding Source
Organization
EN Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo.
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2024 | Year | 01 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) At the conference held by the Department of Hepato-Biliary-Pancreatic Surgery and Artificial Organ Transplantation at the University of Tokyo Hospital, along with collaborative surgical departments at affiliated hospitals, patients eligible for hepatectomy, pancreaticoduodenectomy, and distal pancreatectomy will be evaluated within the scope of standard clinical practice.
(2) Patients deemed eligible for the respective surgeries in (1) will be approached for consent to participate in the study before surgery. Only those who provide consent will be included in this observational study.
(3) The EQ-5D-5L questionnaire will be distributed the day before surgery to assess the patient's quality of life (QOL).
(4) Postoperatively, while receiving standard clinical care, patients will complete the questionnaire at three points: 5 days after surgery, 21-28 days after surgery, and 50-70 days after surgery.
(5) At the 50-70 day postoperative mark, clinical information from medical records is collected.
(6) For other institutions, an input form will be sent via email from the Department of Hepato-Biliary-Pancreatic Surgery and Artificial Organ Transplantation at the University of Tokyo Hospital. The results of the EQ-5D-5L questionnaire and information from medical records will be collected via email. Each facility will anonymize the data, and emails will be encrypted to protect personal information.
<Regarding the Activity Tracker>
- As a secondary evaluation item of postoperative QOL, the patient's physical activity will be investigated.
- The study will target patients undergoing pancreaticoduodenectomy who are included in the research group described in (2).
- The activity tracker will be worn from the first to the fourteenth day after surgery.
- The activity tracker should be worn all day, except during sleep and bathing.
Management information
Registered date
| 2024 | Year | 01 | Month | 05 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060786
