UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015808 |
|---|---|
| Receipt number | R000018393 |
| Scientific Title | Evaluation of effect of Braun enteroenterostomy on the postoperative outcomes after pylorus-preserving pancreatoduodenectomy : a randomized controlled trial |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2017/12/02 11:18:05 |
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Basic information
Public title
Evaluation of effect of Braun enteroenterostomy on the postoperative outcomes after pylorus-preserving pancreatoduodenectomy : a randomized controlled trial
Acronym
Effect of Braun enteroenterostomy on PPPD
Scientific Title
Evaluation of effect of Braun enteroenterostomy on the postoperative outcomes after pylorus-preserving pancreatoduodenectomy : a randomized controlled trial
Scientific Title:Acronym
Effect of Braun enteroenterostomy on PPPD
Region
| Japan |
Condition
Condition
Periampullary diseases (Malignancy)
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of Braun enteroenterostomy added to pylorus-preserving pancreatoduodenectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of delayed gastric emptying
Key secondary outcomes
Incidence of anastomotic site ulceration, operation time, postoperative hospital stay, symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
With Braun enteroenterostomy
Interventions/Control_2
Without Braun enteroenterostomy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) The patients aged 20 years and older
(2) The patients who are scheduled for elective surgery
(3) The patients who will undergo PPPD under general anesthesia
(4) The patients who have PS 2 and under
(5) The patients who have ASA-PS 3 and under
(6) The patients who fully agree to this trial
Key exclusion criteria
(1) The patients who have history of preoperative chemotherapy
(2) The patients who are unable to be given general anesthesia
(3) The patients who have history of pancreatic resection
(4) The patients who are planned to undergo PPPD with laparoscopy
(5) The patients who need conversion to PD
(6) The patients who have unresectable cancer
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nakamura Masafumi |
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 Japan
TEL
092-642-5440
mnaka@surg1.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Fujimoto |
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 Japan
TEL
092-642-5440
Homepage URL
takaakif@surg1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Oncology; Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology Research fund
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2014 | Year | 12 | 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
| 2014 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | 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
Management information
Registered date
| 2014 | Year | 12 | Month | 01 | Day |
Last modified on
| 2017 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018393
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
