UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The usefulness of staging laparoscopy for biliary tract tumor or pancreatic tumor
Title of the study (Brief title)	The usefulness of staging laparoscopy for biliary tract tumor or pancreatic tumor
Region	Japan

Condition
Condition	biliary tract tumor or pancreatic tumor
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The usefulness of staging laparoscopy for biliary tract tumor or pancreatic tumor
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intraoperative blood loss proper diagnosis rate
Key secondary outcomes	Efficacy: incidence of conversion to open surgery, postoperative hospital stay Safety: intraoperative accident, postoperative complications, other general morbidities Curability(case of malignancy): recurrence rate, patterns of recurrence, vital prognosis

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Accurate diagnosis is made by staging laparoscopy for biliary tract or pancreatic tumor.
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	1)benign or low malignant potential tumor located in bililary tract or pancreas 2)pancreatic cancer, duodenum papilla cancer, extrahepatic bile duct cancer 3)ECOG Performance Status 0 or 1 or 2 4)sufficient function of important organs WBC: >=2,000/mm3 and <=10,000/mm3 Platelet: >=50,000/mm3 Cr:=<twice upper limit of normal 5)written informed consent
Key exclusion criteria	1)patients who is judged that laparoscopy is dangerous
Target sample size	30

Research contact person
Name of lead principal investigator	Osamu Itano
Organization	Department of Surgery, Keio University School of Medicine
Division name	Department of Surgery
Address	Shinanomachi 35, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	contact@keio-hpbts.jp

Public contact
Name of contact person	Minoru Kitago
Organization	Department of Surgery, Keio University School of Medicine
Division name	Department of Surgery
Address	Shinanomachi 35, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	contact@keio-hpbts.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	慶応義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 13 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 01 Month 06 Day
Anticipated trial start date	2014 Year 01 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 12 Day
Last modified on	2017 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017144