UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037173 |
|---|---|
| Receipt number | R000042346 |
| Scientific Title | Feasibility and efficacy of Robot-assisted pancreaticoduodenectomy using da Vinci surgical system; Phase II trial. |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2024/07/01 10:58:11 |
* 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
Feasibility and efficacy of Robot-assisted pancreaticoduodenectomy using da Vinci surgical system; Phase II trial.
Acronym
Feasibility and efficacy of Robot-assisted pancreaticoduodenectomy using da Vinci surgical system; Phase II trial.
Scientific Title
Feasibility and efficacy of Robot-assisted pancreaticoduodenectomy using da Vinci surgical system; Phase II trial.
Scientific Title:Acronym
Feasibility and efficacy of Robot-assisted pancreaticoduodenectomy using da Vinci surgical system; Phase II trial.
Region
| Japan |
Condition
Condition
malignant or borderline malignant disease located in pancreas head
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of robot-assisted pancreaticoduodenectomy for malignant or borderline malignant disease located in pancreas head.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative morbidity
Key secondary outcomes
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
robot-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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Performance status; 0 or 1
2. Good function in other organ (ex. bone marrow, heart, lung, liver, renal)
3. Written consent by the free will of the research subject person after sufficient explanation and understanding
Key exclusion criteria
1. Refusal by patient
2. Research being discontinued
3. Findings that omit surgery (ex.metastatic disease)
4. Decision of research member
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Saiura |
Organization
Juntendo University Hospital
Division name
Department of Hepatobiliary-Pancreatic Surgery
Zip code
113-8421
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
a-saiura@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Mise |
Organization
Juntendo University Hospital
Division name
Department of Hepatobiliary-Pancreatic Surgery
Zip code
113-8421
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
miseyo@gmail.com
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
None
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
Juntendo University Hospital
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
kenkyu5858@juntendo.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/38709730/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38709730/
Number of participants that the trial has enrolled
10
Results
The median total operation time was 634 min (interquartile range [IQR], 594-668) with a median resection time of 363 min (IQR, 323-428) and reconstruction time of 123 min (IQR, 107-131). The achievement of the whole procedure was graded as A, "successful", in two patients.
Robot-assisted pancreaticoduodenectomy (RPD) is feasible when performed by surgeons experienced in open procedures. Specific considerations are needed to safely introduce RPD.
Results date posted
| 2024 | Year | 07 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 05 | Month | 07 | Day |
Baseline Characteristics
Patients undergoing RPD
Participant flow
Ten consecutive cases of RPD performed by two surgeons with expertise in open procedures at a single center were assigned to the study.Ten consecutive cases of RPD performed by two surgeons with expertise in open procedures at a single center were assigned to the study.
Adverse events
One patient had a bowel obstruction and needed to undergo re-laparotomy.
Outcome measures
Each case was classified into four grades according to the achievements of the procedures.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 25 | Day |
Last modified on
| 2024 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042346
