UMIN-CTR Clinical Trial

Public title

Evaluation of Early Postoperative Discharge Outcome in Robot-Assisted Pancreaticoduodenectomy

Acronym

Evaluation of Early Postoperative Discharge Outcome in Robot-Assisted Pancreaticoduodenectomy

Scientific Title

Evaluation of Early Postoperative Discharge Outcome in Robot-Assisted Pancreaticoduodenectomy

Scientific Title:Acronym

Evaluation of Early Postoperative Discharge Outcome in Robot-Assisted Pancreaticoduodenectomy

Region

Japan

Condition

Pancreatic head tumor

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In recent years, an increasing number of facilities are performing robot-assisted pancreaticoduodenectomy. Conventional open pancreatoduodenectomy involves a large abdominal wound, which causes severe postoperative pain and requires time for recovery of the patient's general condition, often resulting in a hospital stay of 3 to 4 weeks. Although robot-assisted surgery has a smaller wound and is expected to allow early recovery after surgery, data from other Japanese institutions showed that the hospital stay after robot-assisted pancreatoduodenectomy was 18-24 days, suggesting that the benefits of robot-assisted surgery are not fully realized. On the other hand, in other countries, the length of hospital stay after robot-assisted pancreatoduodenectomy is 7-12 days, which is less than half the length of hospital stay in Japan. The Department of Hepatobiliary Pancreatic and Transplantation Surgery of the University of Tokyo Hospital has been offering management that allows patients to be discharged in around 10 days after robot-assisted pancreatoduodenectomy since January 2023. No rehospitalization has been reported so far. This result is more than acceptable compared to previous reports and merits a prospective study. In this prospective observational study, patients undergoing robot-assisted pancreatoduodenectomy at our hospital will be discharged around 10 days after surgery and followed up as in actual clinical practice. We will then compare the incidence of postoperative complications and rehospitalization rates with those of open pancreaticoduodenectomy from January 2008 to September 2023, and review and evaluate the post-discharge course of our early discharge management from January 2023.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Hospital stays, Complication rates within 30 days, and Readmission rates within 90 days

Key secondary outcomes

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

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients: Patients aged 18 years or older who will undergo robot-assisted pancreaticoduodenectomy with a diagnosis of pancreatic head region tumor between the date of approval and March 31, 2026 at the Department of Hepatobiliary, Pancreatic and Artificial Organs Transplantation, The University of Tokyo Hospital, and who have given their consent.
Control group: Patients who underwent open pancreaticoduodenectomy between January 2008 and September 2023 at the Department of Hepatobiliary and Transplant Surgery, University of Tokyo Hospital.

Key exclusion criteria

Patients under 17 years of age. Patients who cannot give consent. For patients undergoing open pancreaticoduodenectomy, those who have requested refusal.

Target sample size

25

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, Department of Surgery

Zip code

113-0033

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Email

kihase-tky@umin.ac.jp

Name of contact person

1st name	Ryo
Middle name
Last name	Oikawa

Organization

The University of Tokyo Hospital

Division name

Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery

Zip code

113-0033

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Homepage URL

Email

oikawar-sur@h.u-tokyo.ac.jp

Institute

The University of Tokyo hospital

Institute

Department

Personal name

Organization

EN Otsuka Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee, Graduate School of Medicine, The University of Tokyo

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

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

東京大学医学部附属病院（東京都）

Date of disclosure of the study information

2024

Year

02

Month

12

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

2024

Year

01

Month

26

Day

Date of IRB

2024

Year

01

Month

26

Day

Anticipated trial start date

2024

Year

01

Month

26

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1 Patients who are judged to be eligible for robot-assisted pancreatoduodenectomy within the scope of normal medical care at a conference of the Department of Hepatobiliary and Transplant Surgery, The University of Tokyo Hospital are eligible. Robotic-assisted pancreaticoduodenectomy is performed for low-grade diseases at the Department of Hepatobiliary Pancreatology and Transplantation, University of Tokyo Hospital.
2 After explaining the surgery to the patient who will undergo the procedure and obtaining consent, the research will be explained and consent will be obtained.
3 Postoperative care will be provided within the scope of normal medical care, and observational research will be conducted. Postoperative care will be provided in accordance with conventional postoperative management.
4 Data on the number of days of hospitalization including patient information, complication rates within 30 days, and readmission rates within 90 days will be obtained, and patients will be asked to fill out the EQ-5D-5L questionnaire before surgery, at discharge, and during outpatient visits after discharge (approximately on the 21st and 60th days after surgery) to survey their quality of life.
5 We will collect data on open pancreatoduodenectomy performed at the Department of Hepatobiliary and Transplantation Surgery, University of Tokyo Hospital, including patient information on the number of days of hospitalization, complication rate within 30 days, and readmission rate within 90 days.
6 Those data will be analyzed and compared using the statistical free software R, and the results will be reported at conferences and in papers.

Registered date

2024

Year

02

Month

11

Day

Last modified on

2024

Year

08

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061088