UMIN-CTR Clinical Trial

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
Email	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
Email	morimura@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050168