UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045331
Receipt number R000051668
Scientific Title Efficacy and Safety of Robotic Pancreaticoduodenectomy Using Reduced Port Surgery
Date of disclosure of the study information 2021/09/02
Last modified on 2021/12/20 22:46:30

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Basic information

Public title

Efficacy and Safety of Robotic Pancreaticoduodenectomy Using Reduced Port Surgery

Acronym

Efficacy and Safety of Robotic Pancreaticoduodenectomy Using Reduced Port Surgery

Scientific Title

Efficacy and Safety of Robotic Pancreaticoduodenectomy Using Reduced Port Surgery

Scientific Title:Acronym

Efficacy and Safety of Robotic Pancreaticoduodenectomy Using Reduced Port Surgery

Region

Japan


Condition

Condition

pancreatic head lesion disease

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of robotic pancraeticoduodenectomy as reduced port surgery for pancreatic head lesion disease

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

perioperative morbidity

Key secondary outcomes



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

Treatment

Type of intervention

Maneuver

Interventions/Control_1

robotic pancreaticoduodenectomy using reduced port surgery

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Pancreatic head lesion disease that do not require revascularization
2. Enough general condition to withstand this surgery
3. Obtain a written free and voluntary consent from the patient after receiving adequate explanation

Key exclusion criteria

1. refusal by the patient
2. considered an exclusion by the research member

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yoshifumi
Middle name
Last name Beck

Organization

Saitama Medical Center, Saitama Medical University

Division name

Department of Hepatobiliary-Pancreatic Surgery

Zip code

850-3550

Address

1981, Kamoda, Kawagoe, Saitama

TEL

049-228-3620

Email

ybeck@saitama-med.ac.jp


Public contact

Name of contact person

1st name Riki
Middle name
Last name Ninomiya

Organization

Saitama Medical Center, Saitama Medical University

Division name

Department of Hepatobiliary-Pancreatic Surgery

Zip code

850-3550

Address

1981, Kamoda, Kawagoe, Saitama

TEL

049-228-3620

Homepage URL


Email

rickynino9222@gmail.com


Sponsor or person

Institute

Department of Hepatobiliary-Pancreatic Surgery, Saitama Medical Center, Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

none

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

Saitama Medical Center, Saitama Medical University

Address

1981, Kamoda, Kawagoe, Saitama

Tel

049-228-3411

Email

smcrinri@saitama-med.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

2021 Year 09 Month 02 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

Enrolling by invitation

Date of protocol fixation

2021 Year 08 Month 01 Day

Date of IRB

2021 Year 09 Month 28 Day

Anticipated trial start date

2021 Year 09 Month 30 Day

Last follow-up date

2024 Year 03 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

2021 Year 09 Month 01 Day

Last modified on

2021 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051668


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name