UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036957
Receipt number R000042106
Scientific Title study for safety of robot-assisted laparoscopic spleen-preserving distal pancreatectomy using Da Vinci for pancreatic diseases
Date of disclosure of the study information 2019/06/04
Last modified on 2019/06/04 15:01:25

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Basic information

Public title

study for safety of robot-assisted laparoscopic spleen-preserving distal pancreatectomy

Acronym

robot-assisted laparoscopic spleen-preserving distal pancreatectomy

Scientific Title

study for safety of robot-assisted laparoscopic spleen-preserving distal pancreatectomy using Da Vinci for pancreatic diseases

Scientific Title:Acronym

robot-assisted laparoscopic spleen-preserving distal pancreatectomy

Region

Japan


Condition

Condition

pancreatic neoplasm except for cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the safety of robot-assisted laparoscopic spleen-sparing pancreatic caudal resection

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Robot-assisted surgery completion rate
Total adverse event rate

Key secondary outcomes

Operation time, intraoperative blood loss
Postoperative pancreatic fistula rate
Postoperative days


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Robot-assisted laparoscopic spleen-preserving distal pancreatectomy using the Da Vinci Surgical System
One surgical intervention, from start to finish

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) Name of disease: Low-grade pancreatic tumor.
(2) Site: A lesion localized to the tail of the pancreatic body with preservable splenic vessels.
(3) Performance Status : 0-2
(4) The function of the tumor organ is maintained

Key exclusion criteria

(1) History of upper abdominal surgery
(2) Complication of malignant tumor
(3) Complication of active acute pancreatitis, chronic pancreatitis
(4) Emergent operation
(5) Pregnant cases: Pregnancy, lactation
(6) Cases that participation in research is difficult due to a combination of psychosis or psychiatric symptoms
(7) Cases judged by doctors as inappropriate

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Masaharu
Middle name
Last name Ishida

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Surgery

Zip code

989-8574

Address

1-1 Seiryocho, Aobaku, Sendai

TEL

022-717-7205

Email

mishida@surg.med.tohoku.ac.jp


Public contact

Name of contact person

1st name Masaharu
Middle name
Last name Ishida

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Surgery

Zip code

989-8574

Address

1-1 Seiryocho, Aobaku, Sendai

TEL

022-717-7205

Homepage URL


Email

mishida@surg.med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Tohoku University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tohoku University Graduate School of Medicine

Address

1-1 Seiryocho, Aobaku, Sendai

Tel

022-717-7205

Email

mishida@surg.med.tohoku.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

2019 Year 06 Month 04 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

Preinitiation

Date of protocol fixation

2019 Year 06 Month 04 Day

Date of IRB


Anticipated trial start date

2019 Year 08 Month 01 Day

Last follow-up date

2023 Year 12 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

2019 Year 06 Month 04 Day

Last modified on

2019 Year 06 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042106


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name