UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Laparoscopic treatment of congenital biliary dilatation
Title of the study (Brief title)	Laparoscopic treatment of congenital biliary dilatation
Region	Japan

Condition
Condition	Congenital biliary dilatation
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and feasibility of the laparoscopic resection of extrahepatic bile duct and bilio-entero anastomosis for congenital biliary dilatation
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complication rate postoperative hospital stay
Key secondary outcomes

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	Laparoscopic resection of extrahepatic bile duct, bilio-enteric anastomosis
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)Congenital biliary dilatation, Todani classification typeI or IV 2)ECOG Performance Status : 0-2 3)Major organ function is preserved and general anesthesia is possible 4)Signed informed consent
Key exclusion criteria	1)Past history of upper abdominal surgery 2)Synchronous malignancies 3)Emergency surgery 4)Acute or chronic pancreatitis 5)Acute cholangitis 6)Women during pregnancy 7)Patients judged as inadequate by investigators
Target sample size	10

Research contact person
Name of lead principal investigator	Unno Michiaki
Organization	Tohoku University Hospital
Division name	Hepato-Biliary Pancreatic surgery
Address	1-1 Seiryo-cho, Aoba-ku, Sendai, 980-8574, Japan
TEL	022-717-7205
Email	m_unno@surg1.med.tohoku.ac.jp

Public contact
Name of contact person	Takanori Morikawa
Organization	Tohoku University Hospital
Division name	Hepato-Biliary Pancreatic surgery
Address	1-1 Seiryo-cho, Aoba-ku, Sendai, 980-8574, Japan
TEL	022-717-7205
Homepage URL
Email	t_morikawa@surg1.med.tohoku.ac.jp

Sponsor
Institute	Departent of Surgery, Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2011 Year 06 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 27 Day
Anticipated trial start date	2010 Year 12 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
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	2010 Year 12 Month 12 Day
Last modified on	2016 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005595