UMIN-ICDS Clinical Trial

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

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

Narrative objectives1

Currently, minimally invasive surgery (MIS) including laparoscopic and robot-assisted procedures is gaining widespread acceptance in the field of surgery. The field of hepato-biliary-pancreatic surgery is no exception. Starting with the adoption of minimally invasive distal pancreatectomy, pancreaticoduodenectomy and liver resection are now performed using a minimally invasive approach in various medical facilities and MIS is becoming more prevalent. There are many acknowledged benefits of MIS including smaller incisions leading to early patient recovery and improved precision of surgical procedures. A previous study reported that laparoscopic distal pancreatectomy can reduce the length of the postoperative hospital stay compared to open distal pancreatectomy.
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 consider Patient-Reported Outcome Measures (PROMs). The EQ-5D-5L questionnaire is a widely used method of PROMs, consisting of five independent questions which quantify and assess the Quality of Life (QOL) of patients. The questionnaire 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 minimally invasive surgery, there are few studies in the hepato-biliary-pancreatic 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 hepatobiliary pancreatic surgery in Japan. The study is not limited to distal pancreatectomy but also includes pancreaticoduodenectomy and liver resection procedures.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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.

Target sample size

480

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

Email

hasegawa-secretary@umin.ac.jp

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

Email

takeshi.kano0707@gmail.com

Institute

The university of Tokyo hospital

Institute

Department

Personal name

Organization

EN Otsuka Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

Email

ethics@m.u-tokyo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

01

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

This is a non-invasive observational/quantitative study conducted at the Department of Hepato-Biliary-Pancreatic and Transplant Surgery at the University of Tokyo Hospital, as well as the surgery department at affiliated hospitals. The study recruits patients judged as eligible for hepatectomy, pancreaticoduodenectomy, and pancreatectomy at the preoperative conferences. Only patients who provide consent are included in the study.
On the day before the surgery, EQ-5D-5L questionnaires are distributed to assess the patient's Quality of Life (QOL). Postoperatively, the questionnaires are completed at three-time points: 5 days post-surgery, 21-28 days post-surgery, and 50-70 days post-surgery.

Retrospectively medical records are collected including gender, age, height, body weight, ASA physical status, presence of preoperative chemotherapy, history of open surgery, laparoscopic surgery and robotic surgery, presence of preoperative jaundice treatment, surgical procedure, operation time, amount of bleeding, final pathological diagnosis, maximum diameter of tumors, number of tumors, tumor localization, presence of postoperative complications with details, length of postoperative hospital-stay, details of any postoperative readmissions and day of the last drainage tube removal.

An electronic input form is sent via email from the University of Tokyo Hospital to the surgery department at affiliated hospitals. The form is filled out in each institution and sent back to the University of Tokyo Hospital through encrypted email after pseudonymization.

The obtained EQ-5D-5L questionnaire results are analyzed using statistical software R at the University of Tokyo Hospital's Department of Hepato-Biliary-Pancreatic and Transplant Surgery.The results of the analysis are reported at conferences, in journals, or other appropriate forums.

Registered date

2024

Year

01

Month

05

Day

Last modified on

2024

Year

01

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060786