UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of exocrine pancreatic function after esophagectomy and effect using pancrelipase
Title of the study (Brief title)	Exocrine pancreatic function after esophagectomy and effect of pancrelipase
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the efficacy and safety of pancrelipase after operation of esophageal cancer who has low exocrine pancreatic function.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The ratio of frequency of the stool below two times a day. The ratio of bristol scale below 4.
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	orally taking pancrelipase terms: three months amounts: 600mg/meal times: ever time after meal
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) Esophageal cancer patients who is after esophagectomy and coming for follow-up visit. 2) Patients with lower fecal elastase1 than 200mg/g and has higher Bristol scale than 6. 3) Patients who had got informed consent.
Key exclusion criteria	1)Patients who is treating by chemotherapy or radiotherapy. 2)Patients who are allergic to swine protein. 3)Patients who had over 5kg of weight movement. 4)Patients who has a possibility of pregnant or now pregnant, or while nursing. 5)Patients with severe infection. 6)Patients who did not give consent to this research. 7)Patients who are suspected of chronic pancreatitis, after pancreatectomy and other cause of exocrine pancreatic dysfunction. 8)Patients with dyschezia caused by irritable bowel syndrome or inflammatory bowel disease. 9)Patients treated by enteral alimentation.
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshihiro Kakeji
Organization	Kobe University
Division name	Division of Gastrointestinal Surgery
Address	Kusunoki-chou 7-5-2, Chuo-ku, Kobe
TEL	078-382-5925
Email	kakeji@med.kobe-u.ac.jp

Public contact
Name of contact person	Tetsu Nakamura
Organization	Kobe University
Division name	Division of Gastrointestinal Surgery
Address	Kusunoki-chou 7-5-2, Chuo-ku, Kobe
TEL	078-382-5925
Homepage URL
Email	tetsun@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

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)

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	2015 Year 04 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 11 Month 30 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 25 Day
Last modified on	2017 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018016