UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of safety and efficacy of laparoscopy-assisted pancreaticoduodenectomy for benign and low-grade malignant tumor
Title of the study (Brief title)	Laparoscopy-assisted pancreaticoduodenectomy for benign and low-grade malignant tumor
Region	Japan

Condition
Condition	Neuroendocrine tumor mucinous cystic neoplasm serous cystic neoplasm intraductal papillary mucinous neoplasm Solid Pseudopapillary neoplasm , etc.
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of laparoscopy-assisted pancreaticoduodenectomy for benign and low-grade malignant tumor
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complication rate
Key secondary outcomes	Conversion rate Rate of postoperative pancreatic fistula R0 resection rate Postoperative hospital stay

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	Laparoscopy-assisted pancreaticoduodenectomy
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 and low-grade malignant tumor of the pancreatic head 2)ECOG Performance Status:0-1 3)BMI equal to or lower than 25 4)Major organ function is preserved and general anesthesia is possible 5)Signed informed consent
Key exclusion criteria	1)Patients diagnosed as pancreatic ductal carcinoma or suspected 2)Synchronous malignancyes 3)Emergency surgery 4)Acute or chronic pancreatitis 5)Acute cholangitis 6)Women during pregnancy 7)Patients possible to perform enucleation or partial resection 8)Patients judged as inadequate by investigators
Target sample size	10

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

Public contact
Name of contact person	Takanori Morikawa
Organization	Tohoku University Hospital
Division name	Division of 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	Division of Hepato-Biliary Pancreatic surgery, Tohoku University (Graduate School of Medicine)
Institute
Department

Funding Source
Organization	Division of Hepato-Biliary Pancreatic surgery, Tohoku University (Graduate School of Medicine)
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of gastrointestinal and pediatric surgery, Tokyo medical university
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	2013 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 26 Day
Anticipated trial start date	2013 Year 07 Month 01 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	2013 Year 06 Month 04 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=R000012719