UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007426
Receipt number R000008519
Scientific Title A prospective randomized controlled multicenter trial to reduce the incidence of clinical pancreatic fistula after distal pancreatectomy
Date of disclosure of the study information 2012/03/02
Last modified on 2014/10/22 15:03:11

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Basic information

Public title

A prospective randomized controlled multicenter trial to reduce the incidence of clinical pancreatic fistula after distal pancreatectomy

Acronym

A prospective randomized controlled multicenter trial to reduce the incidence of clinical pancreatic fistula after distal pancreatectomy

Scientific Title

A prospective randomized controlled multicenter trial to reduce the incidence of clinical pancreatic fistula after distal pancreatectomy

Scientific Title:Acronym

A prospective randomized controlled multicenter trial to reduce the incidence of clinical pancreatic fistula after distal pancreatectomy

Region

Japan


Condition

Condition

Pancreatic disease required distal pancreatectomy

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the incidence of clinical pancreatic fistula after distal pancreatectomy between distal duct-to-mucosa pancreaticogastorostomy and pancreatic duct ligation with stump closure.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Incidence of clinical pancreatic fistula defined by ISGPF (International Study Group Pancreatic Fistula)

Key secondary outcomes

Incidence of other postoperative morbidity


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Duct-to-mucosa pancreaticogastrostomy after distal pancreaatectomy

Interventions/Control_2

Pancreatic duct ligation with stump closure after distal pancreaatectomy

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with pancreatic disease requiring distal pancreatectomy

Key exclusion criteria

1, Patients with previous history of gastrectomy
2, Patients requireing combined celiac axis resection
3, Patients requireing subtotal distal pancreatectomy with resection of gastroduodenal artery
4, Patients with active gastric ulcer
5, Patients with total laparoscopic distal pancreatectomyT
6, Patients who were diagnosed inadequacy for this study by a physician

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiaki Murakami

Organization

Hiroshima University Hospital

Division name

Gastrointestinal Surgery

Zip code


Address

1-2-3 Kasumi, Minamiku, Hiroshima, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kenichiro Uemura

Organization

Hiroshima University Hospital

Division name

Gastrointestinal Surgery

Zip code


Address

1-2-3 Kasumi, Minamiku, Hiroshima, Japan

TEL

082-257-5216

Homepage URL


Email



Sponsor or person

Institute

Hiroshima University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None


Other related organizations

Co-sponsor

Kansai Medical Univesity Hirakata Hospital

Tohoku Universtiy Hospital

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

2012 Year 03 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

Completed

Date of protocol fixation

2012 Year 02 Month 23 Day

Date of IRB


Anticipated trial start date

2012 Year 03 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

2012 Year 03 Month 02 Day

Last modified on

2014 Year 10 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008519


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name