UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004126
Receipt number R000004956
Scientific Title Efficacy of preoperative endoscopic pancreatic stenting in distal pancreatectomy
Date of disclosure of the study information 2010/10/01
Last modified on 2014/08/21 14:26:44

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Basic information

Public title

Efficacy of preoperative endoscopic pancreatic stenting in distal pancreatectomy

Acronym

Preoperative endoscopic pancreatic stenting in distal pancreatectomy

Scientific Title

Efficacy of preoperative endoscopic pancreatic stenting in distal pancreatectomy

Scientific Title:Acronym

Preoperative endoscopic pancreatic stenting in distal pancreatectomy

Region

Japan


Condition

Condition

Patients who undergo distal pancreatectomy

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To reduce the frequency and severity of post operative pancreatic fistula.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The frequency and severity of post operative pancreatic fistula

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

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Preoperative endoscopic pancreatic stenting

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

18 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Patient who undergo distal pancreatectomy

Key exclusion criteria

1) Younger than 18 years old or older than 86 years old.
2) No written informed consent.
3) History of severe complication after ERCP.
4) Patients seems inadequate for this study by investigators.

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ippei Matsumoto

Organization

Kobe University Graduate School of Medicine

Division name

Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery

Zip code


Address

7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe-City, Hyogo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kobe University Graduate School of Medicine

Division name

Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery

Zip code


Address


TEL

078-382-6302

Homepage URL


Email



Sponsor or person

Institute

Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery, Kobe University Graduate School of Medicine

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


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

神戸大学医学部附属病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2010 Year 10 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

2010 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 10 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

2010 Year 08 Month 30 Day

Last modified on

2014 Year 08 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004956


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name