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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017308
Receipt No. R000019458
Scientific Title A New Prognostic Scoring System Using Preoperatively Available Factors to Predict Survival after Surgical Resection of Hilar Cholangiocarcinoma
Date of disclosure of the study information 2015/04/28
Last modified on 2015/11/25

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Basic information
Public title A New Prognostic Scoring System Using Preoperatively Available Factors to Predict Survival after Surgical Resection of Hilar Cholangiocarcinoma
Acronym Prognostic Scoring System for hilar cholangiocarcinoma
Scientific Title A New Prognostic Scoring System Using Preoperatively Available Factors to Predict Survival after Surgical Resection of Hilar Cholangiocarcinoma
Scientific Title:Acronym Prognostic Scoring System for hilar cholangiocarcinoma
Region
Japan

Condition
Condition Hilar Cholangiocarcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish a new preoperative staging system using preoperatively available factors to predict survival after surgical resection of hilar cholangiocarcinoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 5year survival
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 This study was a retrospective analysis of a prospective database compiled by the Department of Gastroenterological Surgery II at Hokkaido University Hospital. The study protocol received Institutional Review Board approval. All participants provided their written informed consent before treatment. Between July 1999 and October 2009, 131 consecutive patients, who had undergone surgical exploration for perihilar cholangiocarcinoma, were identified from a prospective database maintained by our department.
Key exclusion criteria Ten patients did not undergo tumor resection because of peritoneal implantation or extensive vascular involvement. Six patients, who underwent tumor resection, were excluded from this study because they had insufficient preoperative laboratory data.
Target sample size 131

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takehiro Noji
Organization Hokkaido University Graduate School of Medicine
Division name Gastroenterological Surgery II
Zip code
Address Kita15 Nishi7 Kita-ku, Sapporo city, Japan
TEL 011-716-1161
Email drnoji@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takehiro Noji
Organization Hokkaido University Graduate School of Medicine
Division name Department of Gastroenterological Surgery II
Zip code
Address Kita15 Nishi7 Kita-ku, Sapporo city, Japan
TEL 011-716-1161
Homepage URL
Email drnoji@med.hokudaoi.ac.jp

Sponsor
Institute Hokkaido University Graduate school of Medicine, Department of Gastroenterological surgery II
Institute
Department

Funding Source
Organization Hokkaido University Graduate school of Medicine, Department of Gastroenterological surgery II
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
Address
Tel
Email

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
2015 Year 04 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2015 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We revealed three factors (Platelet-lymphocyte ratio (PLR )>150, serum C-reactive protein (CRP)levels >0.39 mg/dL and carcinoembryonic antigen (CEA) levels >6.5 ng/mL ) were independent prognostic factors of postoperative survival. The three preoperative factors, PLR >150, serum CRP levels >0.39 mg/dL and CEA levels >6.5 ng/mL, were allocated 1 point each. The total score was defined as the Preoperative Prognostic Score (PPS). Patients with a PPS of 0, 1, 2, or 3 had a 5-year survival of 75.9%, 42.3%, 27.0%, and 0% respectively. There were also significant differences in the 5-year survival according to the total PPS (score 0 vs. 1, P=0.039; score 1 vs. 2, P=0.033; score 2 vs. 3, P=0.001). Patients with a total PPS of 3 had dismal prognosis, with a median survival of 3.9 months.

Management information
Registered date
2015 Year 04 Month 28 Day
Last modified on
2015 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019458

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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