UMIN-CTR Clinical Trial

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

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

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

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.

Study type

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nagoya University Graduate School of Medicine

Institute

Department

Personal name

Organization

Nagoya University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

名古屋大学医学部附属病院

Date of disclosure of the study information

2014

Year

06

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

06

Month

06

Day

Last modified on

2014

Year

06

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015983