UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019817
Receipt number R000007508
Scientific Title Phase II randomized clinical trial for the purpose of examining the protective efficacy of the non-alcoholic fatty liver development by pancrelipase preparation being given for pancreatic cancer patients who underwent pancreaticoduodenectomy or total pancreatectomy.
Date of disclosure of the study information 2015/11/17
Last modified on 2019/04/01 18:16:50

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Basic information

Public title

Phase II randomized clinical trial for the purpose of examining the protective efficacy of the non-alcoholic fatty liver development by pancrelipase preparation being given for pancreatic cancer patients who underwent pancreaticoduodenectomy or total pancreatectomy.

Acronym

Phase II randomized clinical trial about the non-alcoholic fatty liver development prevention with the pancrelipase preparation administration

Scientific Title

Phase II randomized clinical trial for the purpose of examining the protective efficacy of the non-alcoholic fatty liver development by pancrelipase preparation being given for pancreatic cancer patients who underwent pancreaticoduodenectomy or total pancreatectomy.

Scientific Title:Acronym

Phase II randomized clinical trial about the non-alcoholic fatty liver development prevention with the pancrelipase preparation administration

Region

Japan


Condition

Condition

To assume the decreased rate of post-operative non-alcoholic fatty liver incidence in pancreatic cancer patients with the prophylactic administration of the pancrelipase preparation.

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assume the decreased rate of post-operative non-alcoholic fatty liver incidence in pancreatic cancer patients with the prophylactic administration of the pancrelipase preparation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of post-opearative non-alcoholic fatty liver disease (within i year after PD)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Intervention group: Administration of Pancrelipase capsule with standard dose.

Interventions/Control_2

Control group: conventional administration of digestive enzymes

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

The patients with pancreatic cancerwho underwent pancreaticoduodenectomy (PD) or total pancreatectomy (TP) for pancreatic cancer.
The patients that the agreement was obtained in a document

Key exclusion criteria

1 The patients who had a diagnosis of non alcoholic fatty liver by perioperative liver biopsy
2 The patients who cannot do initiation of the pancrelipase preparation even if it passes for two months after surgery
3 Alcohol common custom drinking career after surgery
4 Severe obesity BMI>30
5 The patients with the persistent infection of the hepatitis virus
6 The patients who receive steroid treatment
7 The patients with the preoperative fatty liver
8 patients with the allergy to swine protein or digestive enzymes preparation
9 The patients with a grave cardiovascular system, a respiratory system, a digestive system, an urinary system or a mind, the neurological disease
10 The patients with a history of the drug abuse
11 During the pregnancy or the patients nursing and the patients who may be pregnant
12 Patients with acute pancreatitis and patients with bowel obstruction
13 the patients of the acute advanced stage in patients with chronic pancreatitis
14 The patients with the factor that may affect other treatment outcomes and the patients who judged it when a clinical trial responsibility doctor or a clinical trial allotment doctor should not participate in a clinical trial
15 The patients who cannot do it of the self judgment

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sohei SATOI MD

Organization

Kansai Medical University

Division name

Department of Surgery

Zip code


Address

2-3-1, Shin-machi, Hirakata-city, Osaka

TEL

072-804-0101

Email

satoi@hirakata.kmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sohei SATOI MD

Organization

Kansai Medical University

Division name

Department of Surgery

Zip code


Address

2-3-1, Shin-machi, Hirakata-city, Osaka

TEL

072-804-0101

Homepage URL


Email

satoi@hirakata.kmu.ac.jp


Sponsor or person

Institute

Department of Surgery, Kansai Medical University

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

関西医科大学附属枚方病院 外科


Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 17 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

2011 Year 09 Month 08 Day

Date of IRB

2011 Year 11 Month 21 Day

Anticipated trial start date

2011 Year 11 Month 29 Day

Last follow-up date

2015 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 11 Month 17 Day

Last modified on

2019 Year 04 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007508


Research Plan
Registered date File name
2016/11/17 Satoi_et_al-2016-Journal_of_Hepato-Biliary-Pancreatic_Sciences.pdf

Research case data specifications
Registered date File name
2016/11/17 jhbp_14.pdf

Research case data
Registered date File name
2018/05/20 Lipacreon RCT JHBPS 2016.pdf