UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022836 |
|---|---|
| Receipt number | R000026310 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2016/06/22 |
| Last modified on | 2016/12/13 11:55:54 |
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Basic information
Public title
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
Acronym
Prospective multicenter study regarding the safety of surgical results of laparoscopic pancreatic resection
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masafumi Nakamura |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Oncology
Zip code
Address
3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan
TEL
092-642-5441
mnaka@surg1.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Ohtsuka |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Oncology
Zip code
Address
3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan
TEL
092-642-5441
Homepage URL
takao-o@surg1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Japanese Society for Endoscopic Pancreatic Surgery
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 20 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026310
