UMIN-CTR Clinical Trial

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

Hilar Cholangiocarcinoma

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

5year survival

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

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

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

04

Month

28

Day

URL releasing protocol

Publication of results

Published

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

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 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.

Registered date

2015

Year

04

Month

28

Day

Last modified on

2015

Year

11

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019458