UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058092 |
|---|---|
| Receipt number | R000066391 |
| Scientific Title | Hepatolithiasis after pancreaticoduodenectomy |
| Date of disclosure of the study information | 2025/06/06 |
| Last modified on | 2026/07/03 15:10:11 |
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Basic information
Public title
Hepatolithiasis after pancreaticoduodenectomy
Acronym
Hepatolithiasis after pancreaticoduodenectomy
Scientific Title
Hepatolithiasis after pancreaticoduodenectomy
Scientific Title:Acronym
Hepatolithiasis after pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
Hepatolithiasis that occurred after pancreaticoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to investigate the risk factors and appropriate treatment for the hepatolithiasis after pancreaticoduodenectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. To evaluate the risk factors for hepatolithiasis after pancreaticoduodenectomy
2. To evaluate the appropriate treatment for hepatolithiasis after pancreaticoduodenectomy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent pancreaticoduodenectomy at our institution
Key exclusion criteria
None
Target sample size
314
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Hiyoshi |
Organization
Miyazaki Medical Association Hospital
Division name
Department of Surgery
Zip code
880-2102
Address
1173 Arita, Miyazaki-city, Miyazaki, Japan
TEL
+81-985-77-9101
mhiyoshi@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Hiyoshi |
Organization
Miyazaki Medical Association Hospital
Division name
Department of Surgery
Zip code
880-2102
Address
1173 Arita, Miyazaki-city, Miyazaki, Japan
TEL
+81-985-77-9101
Homepage URL
mhiyoshi@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Miyazaki Medical Association Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine, University of Miyazaki
Address
5200 Kihara, Kiyotake Miyazaki
Tel
+81-985-85-9403
rinken@med.miyazaki-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
#O-1502
Org. issuing International ID_1
Research Ethics Committee, Faculty of Medicine, University of Miyazaki
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 | 06 | Month | 06 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
International Journal of Surgery Open 64(2):p 90-94, April 2026. | DOI: 10.1097/IO9.0000000000000344
Number of participants that the trial has enrolled
314
Results
Among the 306 patients, 21 (6.9%) developed hepatolithiasis after PD. Univariate analysis revealed several risk factors for hepatolithiasis after PD, including heavy body weight (P = 0.0096), high body mass index (P = 0.0508), benign disease (P = 0.0109), preoperative drainage (P = 0.0680), and hepaticojejunostomy suture pitch greater than 2 mm (P = 0.0222). Multivariate analysis indicated that only a suture pitch greater than 2 mm (P = 0.0367) was a risk factor for hepatolithiasis after PD.
Results date posted
| 2026 | Year | 06 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
PD was performed in 314 patients. After excluding eight patients who underwent PD with hepatectomy, 306 patients were ultimately evaluated.
Of these, 17 were men and four were women, with a mean age of 67.9 +/- 10.3 years. The underlying disease was malignant in 15 patients and benign in 6.
Participant flow
Between January 2010 and December 2022, 314 patients underwent PD at our hospital.
A cross-sectional study was conducted to evaluate risk factors for hepatolithiasis after PD, including sex, age, height, body weight, body mass index (BMI), diabetes mellitus, final diagnosis, surgical time, blood loss, postoperative complications, preoperative biliary drainage, and postoperative biliary stent insertion.
Adverse events
None
Outcome measures
We aimed to evaluate the risk factors and confirm the appropriate treatment for hepatolithiasis, particularly secondary hepatolithiasis, after pancreaticoduodenectomy.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 06 | Month | 05 | Day |
Last modified on
| 2026 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066391
