UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041642 |
|---|---|
| Receipt number | R000047358 |
| Scientific Title | Prognostic Analysis of Distal Pancreatectomy for Pancreatic Body and/or Tail Cancer |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2025/01/08 17:33:33 |
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Basic information
Public title
Prognostic Analysis of Distal Pancreatectomy for Pancreatic Body and/or Tail Cancer
Acronym
Prognostic Analysis of Distal Pancreatectomy for Pancreatic Body and/or Tail Cancer
Scientific Title
Prognostic Analysis of Distal Pancreatectomy for Pancreatic Body and/or Tail Cancer
Scientific Title:Acronym
Prognostic Analysis of Distal Pancreatectomy for Pancreatic Body and/or Tail Cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we examined the prognostic impact of distal pancreatectomy (DP) or distal pancreatectomy with celiac axis resection (DP-CAR) in patients with portal vein contact of pancreatic body and/or tail cancer, which was evaluated via preoperative computed tomography. Moreover, we consider the appropriate resectability status for the patients with pancreatic body and/or tail cancer involving portal vein and eligible candidates for DP or DP-CAR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between overall survival and portal vein resection and/or the portal vein contact of pancreatic body and/or tail cancer, which was evaluated via preoperative computed tomography in the patients of eligible candidates for DP or DP-CAR
Key secondary outcomes
The relationship between overall survival and preoperative chemo or chemoradiotherapy
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 with pancreatic body and/or tail cancer who underwent DP or DP-CAR between 2002 and 2017
Invasive ductal carcinoma was confirmed by pathological examination
Key exclusion criteria
Histologic type was other than invasive ductal carcinoma
Multiple or asynchronic carcinoma
Target sample size
3531
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Yamamoto |
Organization
Kyoto Prefectural University of Medicine
Division name
Digestive Surgery
Zip code
602-8566
Address
Kajii-cho 465, Kamigyo-ku, Kyoto
TEL
075-251-5111
yamayu-1@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Yamamoto |
Organization
Kyoto Prefectural University of Medicine
Division name
Digestive Surgery
Zip code
602-8566
Address
Kajii-cho 465, Kamigyo-ku, Kyoto
TEL
075-251-5111
Homepage URL
yamayu-1@koto.kpu-m.ac.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Hepato-Biliary-Pancreatic Surgery
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Cancer Center
Address
1007, Shimo-Nagakubo, Sunto-Nagaizumi, Shizuoka
Tel
055-989-5222
yamayu-1@koto.kpu-m.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
長野県厚生農業協同組合連合会 佐久総合病院 佐久医療センター
杏林大学付属病院
愛知県がんセンター
JA北海道厚生連札幌厚生病院
自治医科大学附属さいたま医療センター
金沢大学医学部附属病院
東京女子医科大学病院
順天堂大学医学部附属順天堂医院
九州大学病院
東北大学病院
奈良県立医科大学附属病院
宮崎大学医学部附属病院
広島大学病院
大阪大学医学部附属病院
東京慈恵会医科大学附属病院
富山県立中央病院
静岡県立静岡がんセンター
東京医科歯科大学医学部附属病院
福島県立医科大学附属病院
北海道大学病院
千葉大学医学部附属病院
東京医科大学病院
福山市民病院
京都第二赤十字病院
京都府立医科大学付属病院
岐阜大学医学部附属病院
富山大学附属病院
滋賀医科大学医学部附属病院
新潟県立中央病院
福井大学医学部附属病院
独立行政法人 国立病院機構 岩国医療センター
山形県立中央病院
琉球大学医学部附属病院
社会医療法人仁愛会 浦添総合病院
北海道勤労者医療協会 勤医協中央病院
新潟厚生連長岡中央綜合病院
市立函館病院
日本赤十字社和歌山医療センター
和歌山県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://drive.google.com/file/d/1i9RLuZgOLVg-kKqx3-WpDuRaAacRTl_0/view?usp=drive_link
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
1693
Results
Overall survival (OS) (MST 28.9 month vs. 27.3 months, P = 0.915) was comparable between the PV contact < 180 degree (n = 152) and PV contact > 180 degree (n=16) groups. OS (MST 28.3 months vs. 26.4 months, P = 0.136) were comparable between the PV contact (n = 168) and CeA contact (n = 172) groups. Cox proportional hazards analysis revealed PV contact (hazard ratio, 1.295; P = 0.003) as independent prognostic factors for OS.
Results date posted
| 2023 | Year | 03 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This retrospective study collected the data of patients who underwent DP for PbtCa between January 1, 2001 and December 31, 2017 in the 31 medical institutions in Japan. The study did not include patients with neuroendocrine cell carcinoma, mucinous cystic neoplasm, and intraductal papillary neoplasm. Furthermore, following patients were excluded from this analysis. 1) the patients who underwent remnant DP in those with a past history of PD, 2) the patients with positive lavage cytology and para-aortic lymph node metastasis, 3) the patients with > 180 degree SMA or CeA contact, which was categorized as unresectable pancreatic cancer abutting artery (UR-A) according to the NCCN guidelines, and 4) the patients who intraoperatively converted to total pancreatectomy due to positive pancreatic cut end margin.
Participant flow
Among 2046 patients who underwent DP for pancreatic cancer, 36 patients with insufficient essential data, 140 patients with positive lavage cytology and 48 patients with positive para-aortic lymph node metastasis (11 patients overlapped), 44 patients who underwent remnant DP in those with a history of PD, 75 patients with UR-A with > 180 degree SMA or CeA contact, and 19 patients who underwent intraoperative conversion to TP because of positive pancreatic cut-end margins were excluded. The final analysis included 1693 patients. patients with PV contact (n=168), patients without PV contact (n=1353) and patients with CeA contact (n=172). Patients with PV contact were further divided into those of PV contact < 180 degree (n=152) and PV contact >180 degree (n=16).
Adverse events
none
Outcome measures
The primary endpoint was the prognostic impact of PV contact in PbtCa. The secondary endpoint was the effect of neoadjuvant chemotherapy (NAC) on the OS of study patients.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 16 | Day |
Other
Other related information
Multicenter Retrospective study
Management information
Registered date
| 2020 | Year | 09 | Month | 02 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047358
