UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014200
Receipt No. R000015983
Scientific Title Exploratory study of nutritional status influenced by correlation between pancreas and small intestine
Date of disclosure of the study information 2014/06/06
Last modified on 2014/06/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Exploratory study of nutritional status influenced by correlation between pancreas and small intestine
Acronym NPI trial
Scientific Title Exploratory study of nutritional status influenced by correlation between pancreas and small intestine
Scientific Title:Acronym NPI trial
Region
Japan

Condition
Condition Digestive diseases with a focus on pancreatic disease
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Search of the small intestine and pancreas organ correlation related to nutritional status
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Search of the small intestinal function and pancreatic function correlation related to nutritional status
Key secondary outcomes 1)To evaluate a villus configuration(the degree of atrophy and the density of villus) and the blood flow of villous capillary vessels on endscopic image.
2)To obtain tissues by biopsy, to stain them by hematoxylin and eosin, to measure the height of villus, crypt length, parallel between villus and crypt, glandular cell count, the density of villus, villous capillary veseels inner diameter and square measure and to evaluate a villus configuration quantitatively.
3)To stain the tissues obtained by biopsy immunohistochemical staining(incretin staining(GLP-1 and GIP) and GLP-2R staining) and measure gastrointestinal hormone developing in bowel epithelium and evaluate the function of villus.
4)To evaluate mRNAs(GLP1,2, GIP, GLP2R) by using tissues obtaind by biopsy by real time PCR method and measure gastrointestinal hormone developing in bowel epithelium and evaluate the function of villus.
5)To use an extended observation improvement type small intestine endscope(SIF-Y0007, Olympus medical system, Tokyo Japan) and to evaluate the absorption image of the nutrient(grape carbohydrate solution) in the jejunum villus under extended observation, a change of secondary endpoint[2)-4)] before and after, a comparison between the disease group, pancreatic endocrine and exocrine abilities and the connection with the nourishment state.
6)Nourishment endpoint(BMI, blood examination data).
7)A symptom in conjunction with the pancreas exocrine function imperfection.
8)Subjective symptoms.
9)To evaluate the examination for urine collection C peptide to assume an index of the pancreatic endocrine ability. 10)10)To evaluate an index and the BT-PABA excretion rate(PFD examnation) of the pancreatic exocrine ability.
11)To evaluate the change of villus configuration(the height of villus, crypt length, parallel between villus and crypt, villous capillary veseels inner diameter and paneth cell count) and villous bloodstream over time in comparison with the first enforcement.

Base
Study type

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Upper gastrointestinal endoscopy,including the mucosal biopsy and observation of the jejunum with expansion observed with improved small intestine endoscope(SIF-Y0007, Olympus, Tokyo, Japan)
Interventions/Control_2 Upper gastrointestinal endoscopy, including the mucosal biopsy and observation of the jejunum with improved small intestine endoscope(SIF-Y0002, Olympus, Tokyo, Japan)
Interventions/Control_3 Glucose solution sprayed in the jejunum
Interventions/Control_4 Saline spray in the jejunum
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Around the pancreatic disease cases(chronic pancreatitis, autoimmune pancreatitis, pancreatic cancer, neoplastic pancreatic cysts), to target the cases that require upper gastrointestinal endoscopy on the practice.
The following list includes cases that require upper gastrointestinal endoscopy on the practice.
Patients that require scrutiny of the upper gastrointestinal tract lesions have chronic abdominal pain symptoms.
Patients with digestive tract screening scrutiny of previous abdominal surgery.
Because of high complication rate of esophageal cancer compared to normal in cases pancreatic disease(including pancreatic cancer), patients with the discrimination.
Risk of complicated gastric and duodenal-jejunal invasion, complicated by gastrointestinal bleeding due to invasion or obstruction of the digestive tract is high in pancreatic cancer cases, patients that require the scrutiny even in determining the course of treatment or later.
In after the start of treatment(Chronic pancreatitis: camostat mesylate salt tablets, such as high titer pancreatin formulation oral, pancreatic cancer: (GEM, such as S-1 anti-cancer medical treatment), autoimmune pancreatitis: such as oral steroids), and patients who consent to new must be upper gastrointestinal endoscopy in the follow-up purposes.
Others, there is hope of upper gastrointestinal endoscopy from the patient himself, the test case the attending physician has determined is eligible.
Key exclusion criteria Women who may possibly be pregnant or are pregnant.
Patients with a history of gastric surgery duodenum.
Patients with small bowel surgical history.
Patients with ongoing oral administration antiplatelet agent or anticoagulant.
Patients with conventional oral administration NSAIDs in.
Patients with severe chronic heart failure or severe chronic renal failure.
Patients who do not obtain written consent.
Others, patient physician-deemed inappropriate.

Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Hirooka
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address 65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan.
TEL 052-744-2602
Email hirooka@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daijuro Hayashi
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan.
TEL 052-744-2602
Homepage URL
Email jur16@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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 名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 06 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 Open public recruiting
Date of protocol fixation
2013 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 09 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
2014 Year 06 Month 06 Day
Last modified on
2014 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015983

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.