UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059673 |
|---|---|
| Receipt number | R000066590 |
| Scientific Title | Exploratory Clinical Trial of Low Frequency Therapy for Primary Sclerosing Cholangitis |
| Date of disclosure of the study information | 2025/11/25 |
| Last modified on | 2025/11/06 22:04:25 |
* 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 Clinical Trial of Low Frequency Therapy for Primary Sclerosing Cholangitis
Acronym
LUNCH trial
Scientific Title
Exploratory Clinical Trial of Low Frequency Therapy for Primary Sclerosing Cholangitis
Scientific Title:Acronym
LUNCH trial
Region
| Japan |
Condition
Condition
Primary sclerosing cholangitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Primary sclerosing cholangitis (PSC) is a progressive chronic intrahepatic biliary stasis disease with poor prognosis caused by fibrous stenosis of intrahepatic and extrahepatic bile ducts of unknown cause. On the other hand, the vagus nerve plays a role in regulating inflammatory responses and immune function, in addition to modulating many physiological responses, making vagus nerve stimulation a promising new treatment for a variety of diseases. Recently, transcutaneous auricular vagus nerve stimulation (taVNS) has been investigated. In this study, we aim to evaluate the efficacy, safety, and incidence of adverse events in improving liver injury/serum hepatobiliary enzyme abnormalities by administering taVNS to patients with PSC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in serum ALP levels and Anali score* from study start to 52 weeks post-test
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
| Device,equipment |
Interventions/Control_1
Treatment of transcutaneous auricular vagus nerve stimulation: taVNS
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are 18 years of age or older at the time of obtaining consent
2) Patients who have been diagnosed with PSC based on clinical symptoms or pathological examination
3) Patients whose serum alkaline phosphatase (ALP) level is 1.5 times or more than the upper limit of normal, or whose Anali score is 1 or more.
4) Those who have been evaluated by MRCP (or US/CT if MRCP imaging is difficult) within 6 months.
5) Those who, after receiving sufficient explanation for participation in this study, are able to actively understand the consent document and give written consent of their own free will.
Key exclusion criteria
1) Patients with chronicizing diseases other than PSC (viral hepatitis, metabolic-related liver diseases, alcoholic liver disorders, primary cholestatic cholangitis, Wilson's disease, etc.)
2) Patients with a certain degree of advanced liver damage (serum *AST or ALTNote) exceeding 10 times the upper limit of normal
3) Patients with a history of progressive brain lesions
4) Patients receiving concomitant vagus nerve stimulation therapy
5) Patients with a history of severe cardiovascular disease
6) Pregnant or lactating women
7) Patients with skin hypersensitivity and a history of skin manifestations due to metal or other substances
8) Patients with difficulty in oral intake
9) Patients with severe renal dysfunction (estimated glomerular filtration rate (eGFR) < 30 ml/min)
10) Patients with a cardiac pacemaker or an implantable cardioverter-defibrillator
11) Other subjects who are deemed inappropriate as research subjects by the Principal Investigator or the Principal Investigator.
*AST, aspartate aminotransferase; ALT, alanine aminotransferase
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8648
Address
West 5, North 14, Kita-ku, Sapporo, Hokkaido
TEL
0117161161
mkuwatan@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8648
Address
West 5, North 14, Kita-ku, Sapporo, Hokkaido
TEL
0117161161
Homepage URL
mkuwatan@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Masaki Kuwatani
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
West 5, North 14, Kita-ku, Sapporo, Hokkaido
Tel
0117161161
recjimu@huhp.hokudai.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
| 2025 | Year | 11 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066590
