UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043932
Receipt number R000050168
Scientific Title Efficacy and safety of robot-assisted surgery for pancreatic tumors
Date of disclosure of the study information 2021/06/01
Last modified on 2022/10/17 14:44:44

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Basic information

Public title

Efficacy and safety of robot-assisted surgery for pancreatic tumors

Acronym

Robot Panc

Scientific Title

Efficacy and safety of robot-assisted surgery for pancreatic tumors

Scientific Title:Acronym

Robot Panc

Region

Japan


Condition

Condition

pancreatic tumors

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of laparoscopic surgery for pancreatic tumors using the da Vinci Surgical System.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Presence of all adverse events of grade 3 or higher in the perioperative Clavien-Dindo classification

Key secondary outcomes

Operation time, blood loss, incidence of pancreatic fistula, and percentage of surgeries completed with robotic assistance


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Laparoscopic surgery for pancreatic tumors using the da Vinci Surgical System

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1. Clinically diagnosed pancreatic tumor that is amenable to radical resection
2. ECOG performance status (PS) of 0, 1 or 2
3. Able to obtain written consent from the subject after receiving sufficient explanation of the study contents

Key exclusion criteria

1) Patients with highly advanced cancer, such as those with invasion of other organs
2) Patients with giant tumors with a tumor diameter of 8 cm or more
3) Patients with a history of gastrointestinal surgery by laparotomy (excluding appendicectomy)
4) Patients requiring urgent surgery
5) Patients with the following complications
i. Gastrointestinal bleeding, obstruction of gastrointestinal transit (including paralysis, intestinal obstruction)
ii. symptomatic cardiac disease (including unstable angina, myocardial infarction, heart failure)
iii. Respiratory dysfunction such as interstitial pneumonia, pulmonary fibrosis, etc.
iv. Poorly controlled diabetes mellitus
6) History of the following
i. Myocardial infarction
ii. Cerebral infarction
iii. Deep vein thrombosis, pulmonary infarction

Target sample size

5


Research contact person

Name of lead principal investigator

1st name Eigo
Middle name
Last name Otsuji

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Digestive Surgery

Zip code

6028566

Address

Kawaramachi-Hirokoji, Kamigyo-ku, Kajiicyo 465, Kamikyo-ku, Kyoto City Kyoto, Japan

TEL

0752515527

Email

otsuji@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Hisashi
Middle name
Last name Ikoma

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Digestive Surgery

Zip code

602

Address

Kawaramachi-Hirokoji, Kamigyo-ku, Kajiicyo 465, Kamikyo-ku, Kyoto City Kyoto, Japan

TEL

0752515527

Homepage URL


Email

morimura@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto Prefectural University of Medicine

Address

Kawaramachi-Hirokoji, Kamigyo-ku, Kajiicyo 465, Kamikyo-ku, Kyoto City Kyoto, Japan

Tel

0752515527

Email

rinri@koto.kpu-m.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

京都府立医科大学附属病院


Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 01 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

Terminated

Date of protocol fixation

2021 Year 04 Month 16 Day

Date of IRB

2021 Year 05 Month 31 Day

Anticipated trial start date

2021 Year 06 Month 01 Day

Last follow-up date

2022 Year 09 Month 30 Day

Date of closure to data entry

2022 Year 09 Month 30 Day

Date trial data considered complete

2022 Year 09 Month 30 Day

Date analysis concluded

2022 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2021 Year 04 Month 15 Day

Last modified on

2022 Year 10 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050168


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name