UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031228 |
|---|---|
| Receipt number | R000035662 |
| Scientific Title | Multicenter Prospective registration research for pain relief after EUS-guided neurolysis in patients suffering from upper abdominal cancer pain caused by pancreatic cancer |
| Date of disclosure of the study information | 2018/02/09 |
| Last modified on | 2025/02/14 09:52:03 |
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Basic information
Public title
Multicenter Prospective registration research for pain relief after EUS-guided neurolysis in patients suffering from upper abdominal cancer pain caused by pancreatic cancer
Acronym
Multicenter Prospective registration research for EUS-guided neurolysis
Scientific Title
Multicenter Prospective registration research for pain relief after EUS-guided neurolysis in patients suffering from upper abdominal cancer pain caused by pancreatic cancer
Scientific Title:Acronym
Multicenter Prospective registration research for EUS-guided neurolysis
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of EUS-guided neurolysis in patients suffering from upper abdominal cancer pain caused by pancreatic cancer in multicenter prospective registration research.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy one week after the procedure
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
1. Over 20-year-old
2. Patients with pancreatic cancer
3. Patients with NRS score more than 3
4. PS0-2
5. Patients without severe complication
6. Acquisition of informed consent
Key exclusion criteria
1. Patients with high-risk of bleeding
2. Difficulty of performing EUS
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Kamata |
Organization
Kindai University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
589-8511
Address
377-2, Ohno-Higashi, Osaka-Sayama, Osaka, Japan
TEL
072-366-0221
ky11@leto.eonet.ne.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Kamata |
Organization
Kindai University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
589-8511
Address
377-2, Ohno-Higashi, Osaka-Sayama, Osaka, Japan
TEL
072-366-0221
Homepage URL
ky11@leto.eonet.ne.jp
Sponsor or person
Institute
Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kindai University Faculty of Medicine
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
Kindai University Faculty of Medicine
Address
377-2, Ohno-Higashi, Osaka-Sayama, Osaka
Tel
0723660221
ky11@leto.eonet.ne.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
| 2018 | Year | 02 | Month | 09 | Day |
Related information
URL releasing protocol
NA
Publication of results
Published
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
51
Results
The technical success rates of EUS-CPN and EUS-CGN were 100% and 80.4%, respectively. The overall efficacy rate was 82.4% [90% confidence interval (CI) 71.2-90.5, P < 0.0001]. The complete pain relief rate was 27.4%. The adverse events rate was 15.7%. The average pain relief period was 72 days. The efficacy rate was higher in the EUS-CPN plus EUS-CGN group than in the EUS-CPN alone group.
Results date posted
| 2025 | Year | 02 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Fifty-one consecutive patients with pancreatic cancer-associated pain who presented at one of five Japanese referral centers between February 2018 and March 2021 were enrolled.
Participant flow
EUS-CGN was added in cases of visible celiac ganglia. The primary endpoint was effectiveness, defined as a decrease in the numerical rating scale (NRS) by more than 3 points. NRS data were prospectively acquired at 1 week after the procedure to evaluate its effectiveness and the extent of pain relief.
Adverse events
The adverse events rate was 15.7%.
Outcome measures
The primary endpoint was effectiveness, defined as a decrease in the numerical rating scale (NRS) by more than 3 points. NRS data were prospectively acquired at 1 week after the procedure to evaluate its effectiveness and the extent of pain relief.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2025 | Year | 02 | Month | 14 | Day |
Date trial data considered complete
| 2025 | Year | 02 | Month | 14 | Day |
Date analysis concluded
| 2025 | Year | 02 | Month | 14 | Day |
Other
Other related information
The efficacy one week after the procedure is evaluated as the primary endpoint.
Management information
Registered date
| 2018 | Year | 02 | Month | 09 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035662
