UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009816
Receipt number R000011502
Scientific Title Comparison of pancrelipase and pancreatin for treatment of patients with pancreatic exocrine insufficiency due to pancreatic resection
Date of disclosure of the study information 2013/01/20
Last modified on 2014/11/04 22:45:13

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Basic information

Public title

Comparison of pancrelipase and pancreatin for treatment of patients with pancreatic exocrine insufficiency due to pancreatic resection

Acronym

Pancrelipase vs. Pancreatin for treatment of pancreatc exocrine insufficiency due to pancreatic resection (PEC trial)

Scientific Title

Comparison of pancrelipase and pancreatin for treatment of patients with pancreatic exocrine insufficiency due to pancreatic resection

Scientific Title:Acronym

Pancrelipase vs. Pancreatin for treatment of pancreatc exocrine insufficiency due to pancreatic resection (PEC trial)

Region

Japan


Condition

Condition

Patients who will undergo pancreatectomy

Classification by specialty

Surgery in general Hepato-biliary-pancreatic surgery Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine the efficacy and safety outcomes of pancrealipase treatment on long term nutritional condition for patients with pancreatic resection

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Increased level of serum albumin after treatment for 24 weeks compared with preoperative level.

Key secondary outcomes

1)nutrient assessment
2)condition of stool
3)Body composition(%)
4)edema


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

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pancrelipase group:
600mg of pancrelipase to be taken three times a day (1800mg /day) after meals for 24weeks.

Interventions/Control_2

Pancreatin group:
One gram of pancreatin to be taken three times a day (3g /day) after meals for 24weeks.

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

1)Patients who are scheduled to undergo pancreticoduodenectomy or distal pancreatectomy or total pancreatectomy
2)No prior therapy of pancreatic surgery
3)Written informed consent.
4)Age of at least 20 years old at the time of registration.
5)Performance status of 0 or 1.

Key exclusion criteria

1)Case with possibility of pregnancy or during nursing
2)Sever infection
3)Malabsorption syndrome without pancreatic disease
4)Alegyin porcine or bovine protein or digestive enzym
5)Participates in other examinations of pancreatic exocrine insufficiency.
6)The case judged to be inappropriate for the examination to carry out this study safely by attending doctor

Target sample size

62


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaru Miyazaki

Organization

Chiba University Hospital

Division name

Hepatobiliary Pancreatic Surgery

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, 260-8677, JAPAN

TEL

81-43-222-7171

Email

masaru@faculty.chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideyuki Yoshitomi

Organization

Chiba University Hospital

Division name

Hepatobiliary Pancreatic Surgery

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, 260-8677, JAPAN

TEL

043-222-7171

Homepage URL


Email

yoshitomi@faculty.chiba-u.jp


Sponsor or person

Institute

Chiba University, Graduate School of Medicine, Department of General Surgery

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



Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 20 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

2012 Year 12 Month 15 Day

Date of IRB


Anticipated trial start date

2013 Year 01 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

2013 Year 01 Month 20 Day

Last modified on

2014 Year 11 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011502


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name