UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057702 |
|---|---|
| Receipt number | R000065931 |
| Scientific Title | Clinicopathological and Physiological Analysis of Intracholecystic Papillary Neoplasms: A nationwide project study of Japanese society of Hepato-Biliary-Pancreatic Surgery |
| Date of disclosure of the study information | 2025/04/24 |
| Last modified on | 2025/04/23 21:16:52 |
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Basic information
Public title
Clinicopathological and Physiological Analysis of Intracholecystic Papillary Neoplasms
Acronym
Clinicopathological and Physiological Analysis of Intracholecystic Papillary Neoplasms
Scientific Title
Clinicopathological and Physiological Analysis of Intracholecystic Papillary Neoplasms: A nationwide project study of Japanese society of Hepato-Biliary-Pancreatic Surgery
Scientific Title:Acronym
Clinicopathological and Physiological Analysis of Intracholecystic Papillary Neoplasms
Region
| Japan |
Condition
Condition
Intracholecystic papillary neoplasm
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The concept of intracholecystic papillary neoplasm (ICPN) was first described in the 4th edition of the WHO Classification of Tumors of the Digestive System in 2010, under the term of intracystic papillary neoplasms. It was positioned as a precancerous or preinvasive lesion of the gallbladder. However, subsequent studies by Adsay et al. revealed that ICPNs exhibit papillary proliferation, are associated with high-grade dysplasia, and may be accompanied by invasive carcinoma. In the 5th edition of the WHO Classification published in 2019, ICPN was redefined as a non-invasive epithelial neoplasm that presents as a mass-forming, exophytic growth within the gallbladder lumen. It is now classified into four histological subtypes: biliary type, gastric type, intestinal type, and oncocytic type. To date, there has been no nationwide study on ICPN in Japan, and its clinicophysiological features, degree of dysplasia, and prognostic differences among the subtypes remain unclear. Furthermore, due to the evolving nature of the concept, there are cases in which the diagnosis and subclassification of ICPN remain controversial.
Basic objectives2
Others
Basic objectives -Others
To date, no nationwide study on ICPN has been conducted in Japan, and its clinicophysiological characteristics, degree of dysplasia, and prognosis according to subtype remain unclear. In this study, we aim to elucidate the features of ICPN in Japan through a nationwide case analysis conducted at high-volume training institutions accredited by the Japanese Society of Hepato-Biliary-Pancreatic Surgery.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall Survival by Subgroups Stratified According to WHO Histopathological Classification
Key secondary outcomes
1 Comparison Between Subgroups Stratified by WHO Histopathological Classification and Clinical Background
2 Analysis of Preoperative Clinicophysiological Factors in Subgroups Stratified by WHO Classification
3 Progression-Free Survival in Subgroups Stratified by WHO Histopathological Classification
4 Comparative Analysis of WHO Classification With TNM Staging and the Japanese Classification of Biliary Tract Cancers
5 Investigation of Prognostic Factors Based on Preoperative Clinicophysiological and Pathological Findings in ICPN
6 Association of Background, Clinicophysiological Factors, and Prognosis With Subgroups Stratified by Each Histopathological Diagnosis
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Patients who underwent surgical resection and were diagnosed with ICPN based on the 5th edition of the WHO Classification of Tumors of the Digestive System at each participating institution.
2 Patients with available pathological slides diagnosed as ICPN.
Key exclusion criteria
1 In cases where there were doubts regarding the submitted pathological data, a central pathological review was conducted by the Department of Investigative Pathology, Tohoku University Graduate School of Medicine. Patients who were ultimately not diagnosed with ICPN based on this final pathological assessment were excluded from the study. For excluded patients, the participating institution was informed of the reason when the pathological slides were returned, and relevant information was provided. The collected data for such patients were deleted by the principal investigator.
2 Patients who expressed a desire not to participate in the study.
Target sample size
345
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | suzuki |
Organization
Ibaraki Medical Center, Tokyo Medical University
Division name
Department of Gastroenterological Surgery
Zip code
300-0395
Address
3-20-1 Chuo, Ami, Inashikigunn,Ibaraki, Japan
TEL
029-887-1161
ssuzuki@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Miyamoto |
Organization
Ibaraki Medical Center, Tokyo Medical University
Division name
Department of Gastroenterological Surgery
Zip code
300-0395
Address
3-20-1 Chuo, Ami, Inashikigunn,Ibaraki, Japan
TEL
029-887-1161
Homepage URL
ssuzuki@tokyo-med.ac.jp
Sponsor or person
Institute
Ibaraki Medical Center, Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Medical Center, Tokyo Medical University
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
Institutional Review Board of Tokyo Medical University
Address
6-7-1, Nishishinjyuku, Shinjyuku,Tokyo,Japan
Tel
03-3342-6111
Adm_IRB@tokyo-med.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 | 04 | Month | 24 | 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
345
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical information of eligible patients will be collected from medical records regarding the items listed below, in order to analyze the clinical characteristics, diagnostic methods, treatment, and safety related to the disease. The diagnostic criteria for ICPN have undergone revisions from the 2010 WHO Classification to the 2019 edition, during which both the definition and classification system, including malignancy grading, were updated. However, discrepancies may arise among pathologists in the diagnosis and classification of ICPN.
In cases where there are concerns or inconsistencies in the submitted pathological data, the pathological slides will be sent to Professor Toru Furukawa of the Department of Investigative Pathology, Tohoku University Graduate School of Medicine, for central review and evaluation of the pathological findings in question.
Management information
Registered date
| 2025 | Year | 04 | Month | 23 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065931
