UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective multicenter study regarding the safety of surgical results of laparoscopic pancreatic resection; Japanese Society for Endoscopic Pancreatic Surgery, Japanese Society of Hepato-Biliary-Pancreatic Surgery, and Japan Society for Endoscopic Surgery cooperative study
Title of the study (Brief title)	Prospective multicenter study regarding the safety of surgical results of laparoscopic pancreatic resection
Region	Japan

Condition
Condition	Pancreatobiliary diseases (Patients planned to undergo laparoscopic pancreatic resection)
Classification by specialty	Hepato-biliary-pancreatic surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Validating the safety of surgical results of laparoscopic pancreatic resection with a prospective multicenter study.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Outcome of the operation (dead or alive)
Key secondary outcomes	Operation time, rate of postoperative complications, length of hospital stay, cause of postoperative death

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	Patients planned to undergo laparoscopic pancreatic resection and obtained written informed consent
Key exclusion criteria	Not written informed consent
Target sample size	3000

Research contact person
Name of lead principal investigator	Masafumi Nakamura
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Surgery and Oncology
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan
TEL	092-642-5441
Email	mnaka@surg1.med.kyushu-u.ac.jp

Public contact
Name of contact person	Takao Ohtsuka
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Surgery and Oncology
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan
TEL	092-642-5441
Homepage URL
Email	takao-o@surg1.med.kyushu-u.ac.jp

Sponsor
Institute	Japanese Society for Endoscopic Pancreatic Surgery
Institute
Department

Funding Source
Organization	Japanese Society for Endoscopic Pancreatic Surgery
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Japanese Society of Hepato-Biliary-Pancreatic Surgery Japan Society for Endoscopic Surgery
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	2016 Year 06 Month 22 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 04 Month 20 Day
Anticipated trial start date	2016 Year 06 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	A prospective multicenter study cohort study All patients, who are planned to undergo laparoscopic pancreatic resection between 2016/4/1 and 2020/12/31, will be included in this study, if written informed consents are obtained. Registration Before operation Sex, age, body height, body weight, BMI, preoperative diagnosis, tumor location, planned operative method, approval by IRB, and planned date of operation. After operation Operator, First assistant, Date of operation performed, performed operative method, conversion to laparotomy, kinds of operation (laparoscopic, laparoscopy assisted or robotic), ASA status, operation time, volume of blood loss, and transfusion. After discharge Date of discharge, outcome at discharge (dead or alive), complications within one month after operation, and pancreatic fistula. Three months after operation Histological diagnosis, re-admission, and outcome at 3 months after operation.

Management information
Registered date	2016 Year 06 Month 22 Day
Last modified on	2016 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026310