UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010790 |
|---|---|
| Receipt number | R000012629 |
| Scientific Title | Evaluation for pancreatic blood flow and ability of endocrine in patients with portal hypertension |
| Date of disclosure of the study information | 2013/05/23 |
| Last modified on | 2025/12/01 10:24:27 |
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Basic information
Public title
Evaluation for pancreatic blood flow and ability of endocrine in patients with portal hypertension
Acronym
Pancreatic blood flow in patients with portal hypertension
Scientific Title
Evaluation for pancreatic blood flow and ability of endocrine in patients with portal hypertension
Scientific Title:Acronym
Pancreatic blood flow in patients with portal hypertension
Region
| Japan |
Condition
Condition
portal hypertension
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the pancreatic blood flow and the endocrine function in patients with portal hypertension.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The diameter and wall-thickness of the pancreatic vein.
Degree of the insulin secretion in the islet of the pancreas.
The pancreatic hemodynamics by the ultrasonography.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who underwent autopsy at the Ehime University Hospital from April, 2000 to October, 2012.
The patients with liver biopsy were diagnosed chronic hepatitis or cirrhosis histologically.
The control group.
Key exclusion criteria
Alcohol; more than 20g/day.
Heart failure.
During the pregnancy or while nursing.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Teru |
| Middle name | |
| Last name | Kumagi |
Organization
Ehime University Hospital
Division name
Gastroenterology and Metabology
Zip code
791-0295
Address
Shizukawa, Toon, Ehime, Japan
TEL
81-89-960-5308
3naika@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Teru |
| Middle name | |
| Last name | Kumagi |
Organization
Ehime University
Division name
Gastroenterology and Metabology
Zip code
791-0295
Address
Shizukawa, Toon, Ehime, Japan
TEL
81-89-960-5308
Homepage URL
3naika@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ehime University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ehime University Hospital
Address
Shizukawa, Toon, Ehime, Japan
Tel
81-89-960-5308
3naika@m.ehime-u.ac.jp
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 | 05 | Month | 23 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00535-014-1001-8
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00535-014-1001-8
Number of participants that the trial has enrolled
41
Results
In the CE-US study, clinical signs of portal hypertension were more frequent in the cirrhotic group. Pancreatic drainage time was longer and showed a significant negative correlation with delta CPR. In the histopathological study, islets were enlarged in the cirrhotic group, but the insulin-positive area per islet was reduced and negatively correlated with pancreatic vein wall thickness.
Results date posted
| 2025 | Year | 12 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Pancreatic perfusion parameters were analyzed by dynamic contrast-enhanced ultrasound (CE-US) in 41 patients (20 cirrhotic, 21 non-cirrhotic; age, 67.9 +/- 13.3; female, 19), and prospectively compared to delta C-peptide immunoreactivity (delta CPR). In a separate study, a retrospective chart review with human autopsy specimens was conducted, and vessels and islets of the pancreas were analyzed in 43 patients (20 cirrhotic, 23 controls; age, 71.5 +/- 11.6; female, 15).
Participant flow
The CE-US Study
Consecutive patients who were hospitalized in Ehime University hospital and who were aged >= 20 years were enrolled prospectively between April 2012 and July 2013. The patients were divided into an LC group and a control group. In the LC group, all patients had a histologically proven diagnosis of LC based on liver biopsy. The control group had no past medical history of pancreatic disease or diabetes. For both groups, patients were excluded if they had laboratory increases in pancreatic enzyme (amylase > 200 IU/L and/or lipase > 49 IU/L), had morphologic changes in the pancreas (e.g., pancreatic tumors, cysts, enlargement, calcification, or dilatation/narrowing of the main pancreatic duct) reported on abdominal imaging (helical computed tomography, magnetic resonance cholangiopancreatography, and ultrasonography), had past treatment history related to portal hypertension [splenectomy, partial splenic embolization, or balloon-occluded retrograde transvenous obliteration (B-RTO)], had diabetes (fasting plasma glucose of < 110 mg/dL and/or glycated hemoglobin of < 6.0%), consumed > 20 g of alcohol per day, were administered beta-blockers, or had a clinical condition that could have caused portal hypertension, including chronic heart failure and portal vein tumor thrombosis. Patients were also excluded if a pancreatic ultrasound image had not been obtained. CE-US and the glucagon challenge test were performed in all eligible patients, and the results were compared between the 2 groups.
The pathological study
A retrospective chart review was conducted and included 43 consecutive patients who underwent autopsy at Ehime University Hospital or Saiseikai Imabari Hospital between April 2000 and October 2012. The patients were also divided into an LC group and a control group. Patients were excluded if they had anatomical changes in the pancreas; had a past medical history of diabetes, splenectomy, partial splenic embolization, or B-RTO; consumed > 20 g of alcohol per day; were administered beta-blockers; or had a clinical condition that could have caused portal hypertension, including chronic heart failure and portal vein tumor thrombosis. The wall thickness of the pancreatic vein, the diameters of the islet cells, the percentages of insulin- or glucagon-positive area per islet, the number of insulin-positive cells, and the percentage of insulin-positive cells per islet (from the pancreas specimens that were obtained) were compared between the 2 groups.
Adverse events
None
Outcome measures
The CE-US study
The primary outcome measure was a correlation of the time-intensity curve derived from the CE-US results (time from peak to 1/2 peak in the washout phase, which reflects drainage time from the pancreas) and delta CPR. The secondary outcome measures included time to peak, time from 1/2 peak to peak of the wash-in phase, peak intensity, time from peak to 1/2 peak of the washout phase, the diameter of the portal vein, and delta CPR.
The pathological study
The primary outcome measure was the correlation between the wall thickness of the pancreatic vein and the percentage of the insulin-positive area per islet. The secondary outcome measures included the wall thickness of the pancreatic vein, the diameter of the islet cell, the percentage of insulin- and glucagon-positive area per islet, the number of insulin-positive cells, and the percentage of insulin-positive cells per islet.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The evaluation for pancreatic blood flow in the patients with portal hypertension.
Management information
Registered date
| 2013 | Year | 05 | Month | 23 | Day |
Last modified on
| 2025 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012629
