UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046551
Receipt number R000053112
Scientific Title The efficiency of hepatopancreatoduodenectomy for biliary malignancy
Date of disclosure of the study information 2022/01/05
Last modified on 2023/10/04 13:41:16

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Basic information

Public title

The efficiency of hepatopancreatoduodenectomy for biliary malignancy

Acronym

The efficiency of hepatopancreatoduodenectomy for biliary malignancy

Scientific Title

The efficiency of hepatopancreatoduodenectomy for biliary malignancy

Scientific Title:Acronym

The efficiency of hepatopancreatoduodenectomy for biliary malignancy

Region

Japan


Condition

Condition

Biliary malignancy

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determine the appropriate indication for HPD in patients with advanced biliary tract cancer by examining the relationship between 5-year survival and clinical information.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

5-year survival rate

Key secondary outcomes

(1) Perioperative outcomes (complications and mortality)
2) Association between clinical factors and long-term prognosis


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

(1) Those who have undergone HPD
2) Those who do not refuse to participate in this study.

Key exclusion criteria

(1) Patients with insufficient clinical data
(2) Other patients who are judged by the principal investigator to be unsuitable as research subjects.

Target sample size

61


Research contact person

Name of lead principal investigator

1st name Takehiro
Middle name
Last name Noji

Organization

Hokkaido University Hosp

Division name

Gastroenterological surgery II

Zip code

060-8638

Address

Kita14 Nishi5, Kita-ku, Sapporo city, Japan

TEL

0117067714

Email

drnoji@med.hokudai.ac.jp


Public contact

Name of contact person

1st name Takehiro
Middle name
Last name Noji

Organization

Hokkaido University Hospital

Division name

Gastroenterological surgery II

Zip code

060-8638

Address

Kita14 Nishi5, Kita-ku, Sapporo city

TEL

0117067714

Homepage URL


Email

drnoji@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University Hosp

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

IRB Hokkaido University Hospital

Address

Kita14 Nishi5, Kita-ku, Sapporo city, Hokkaido Japan

Tel

011-716-1161

Email

crjimu@huhp.hokudai.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

2022 Year 01 Month 05 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


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

2022 Year 01 Month 05 Day

Date of IRB

2022 Year 01 Month 31 Day

Anticipated trial start date

2022 Year 01 Month 05 Day

Last follow-up date

2026 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We will collect medical information on the research subjects up to 31 August 2026 and investigate the following items

1) Background information: age, sex, medical history, diagnosis, treatment history, performance status
2) Hematological examination results: hemoglobin, white blood cell count, white blood cell fraction and platelet count
3) Blood chemistry test results: total protein, albumin, Na, K, serum tumor marker (CEA/CA19-9)
4) CT, MRI, ultrasound and cholangiogram results
5) Results of histopathological examination (histological type, degree of progression, lymph node metastasis)
(6) Operative procedure, operative time, amount of blood loss
7) Postoperative course (presence of complications)
(viii) Type and duration of postoperative treatment.
(viii) Type and duration of postoperative treatment (ix) Time to recurrence, site of recurrence, prognosis of life, date of last hospital visit, cause of death


Management information

Registered date

2022 Year 01 Month 05 Day

Last modified on

2023 Year 10 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053112