UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043932 |
|---|---|
| Receipt number | R000050168 |
| Scientific Title | Efficacy and safety of robot-assisted surgery for pancreatic tumors |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2022/10/17 14:44:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy and safety of robot-assisted surgery for pancreatic tumors
Acronym
Robot Panc
Scientific Title
Efficacy and safety of robot-assisted surgery for pancreatic tumors
Scientific Title:Acronym
Robot Panc
Region
| Japan |
Condition
Condition
pancreatic tumors
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of laparoscopic surgery for pancreatic tumors using the da Vinci Surgical System.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Presence of all adverse events of grade 3 or higher in the perioperative Clavien-Dindo classification
Key secondary outcomes
Operation time, blood loss, incidence of pancreatic fistula, and percentage of surgeries completed with robotic assistance
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Laparoscopic surgery for pancreatic tumors using the da Vinci Surgical System
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Clinically diagnosed pancreatic tumor that is amenable to radical resection
2. ECOG performance status (PS) of 0, 1 or 2
3. Able to obtain written consent from the subject after receiving sufficient explanation of the study contents
Key exclusion criteria
1) Patients with highly advanced cancer, such as those with invasion of other organs
2) Patients with giant tumors with a tumor diameter of 8 cm or more
3) Patients with a history of gastrointestinal surgery by laparotomy (excluding appendicectomy)
4) Patients requiring urgent surgery
5) Patients with the following complications
i. Gastrointestinal bleeding, obstruction of gastrointestinal transit (including paralysis, intestinal obstruction)
ii. symptomatic cardiac disease (including unstable angina, myocardial infarction, heart failure)
iii. Respiratory dysfunction such as interstitial pneumonia, pulmonary fibrosis, etc.
iv. Poorly controlled diabetes mellitus
6) History of the following
i. Myocardial infarction
ii. Cerebral infarction
iii. Deep vein thrombosis, pulmonary infarction
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Eigo |
| Middle name | |
| Last name | Otsuji |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Digestive Surgery
Zip code
6028566
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kajiicyo 465, Kamikyo-ku, Kyoto City Kyoto, Japan
TEL
0752515527
otsuji@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Ikoma |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Digestive Surgery
Zip code
602
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kajiicyo 465, Kamikyo-ku, Kyoto City Kyoto, Japan
TEL
0752515527
Homepage URL
morimura@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kajiicyo 465, Kamikyo-ku, Kyoto City Kyoto, Japan
Tel
0752515527
rinri@koto.kpu-m.ac.jp
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
京都府立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 15 | Day |
Last modified on
| 2022 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050168
