UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015328
Receipt number R000017823
Scientific Title Lapoaroscopic pancreatoduodenectomy evaluated by novel self-apprisal system. The surgical phase I trial.
Date of disclosure of the study information 2014/10/02
Last modified on 2016/10/03 09:20:37

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Lapoaroscopic pancreatoduodenectomy evaluated by novel self-apprisal system. The surgical phase I trial.

Acronym

Lap-PD surgical phase I

Scientific Title

Lapoaroscopic pancreatoduodenectomy evaluated by novel self-apprisal system. The surgical phase I trial.

Scientific Title:Acronym

Lap-PD surgical phase I

Region

Japan


Condition

Condition

periampullary tumor

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of novel evaluation system for Lap-PD.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

The grade of achievement of Lap-PD

Key secondary outcomes

Perisurgical outcomes
Surgical curability
Length of incision
Length of hospital stay


Base

Study type


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

To apply the laparoscopic approach to pancreatoduodenectomy

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) Good performance status
2) 19<age<81
3) The fair or more function of major organs is mainteined.
4) No past history of upper abdominal surgery except laparoscopic cholesysteectomy
5) Written informed consent is obtained

Key exclusion criteria

1)Contraindications for pneumoperitomeum

2)The cases who were judged unsuitable for the trial by the attending doctor.

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akio Saiura

Organization

Japanese foundation for cancer research, Cancer institute hospital

Division name

The dept of digestive and HBP surgery

Zip code


Address

3-8-31, Ariake, Koto-ku, Tokyo

TEL

+81-3-3520-0111

Email

sukeyaubj@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yosuke Inoue

Organization

Japanese foundation for cancer research, Cancer institute hospital

Division name

The dept of digestive and HBP surgery

Zip code


Address

3-8-31, Ariake, Koto-ku, Tokyo

TEL

+81-3-3520-0111

Homepage URL


Email

sukeyaubj@yahoo.co.jp


Sponsor or person

Institute

Japanese foundation for cancer research, Cancer institute hospital

Institute

Department

Personal name



Funding Source

Organization

Japanese foundation for cancer research, Cancer institute hospital

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2014 Year 10 Month 02 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2013 Year 05 Month 05 Day

Date of IRB


Anticipated trial start date

2013 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 02 Day

Last modified on

2016 Year 10 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017823


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name