UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005463 |
|---|---|
| Receipt number | R000006481 |
| Scientific Title | Effect of Stapled vs. Hand-sewn duodenal reconstruction on delayed gastric emptying during pancreaticoduodenectomy: a dual-center randomized controlled trial |
| Date of disclosure of the study information | 2011/04/19 |
| Last modified on | 2013/08/08 19:43:38 |
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Basic information
Public title
Effect of Stapled vs. Hand-sewn duodenal reconstruction on delayed gastric emptying during pancreaticoduodenectomy: a dual-center randomized controlled trial
Acronym
SH-Trial
Scientific Title
Effect of Stapled vs. Hand-sewn duodenal reconstruction on delayed gastric emptying during pancreaticoduodenectomy: a dual-center randomized controlled trial
Scientific Title:Acronym
SH-Trial
Region
| Japan |
Condition
Condition
Peirampullary tumor
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the incidence of delayed gastric emptying in patients undergoing pylorus-preserving pancreaticoduodenectomy between stapled and hand-sewn duodeno-jejunostomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of delayed gastric emptying defined by ISGPS
Key secondary outcomes
reconstruction time, findings on upper gastrography on day 4-7, incidence of pancreatic fistula, incidence of complication, hospital stay, rate of body weight loss
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention is stapled anastomosis using circular stapler on duodeno-jejunostomy after pancreaticoduodenectomy
Interventions/Control_2
Control arm is hand-sewn anastomosis on duodeno-jejunostomy after pancreaticoduodenectomy
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
On the diagnosis of periampullary malignancy, benign tumor or inflammatory disease, the patient is going to undergo pylorus-preserving pancreaticoduodenectomy with duodeno-jejunostomy
Key exclusion criteria
1) patients undergoing total pancreatectomy
2) patients who has undergone gastric bypass or gastrectomy
3) patients undergoing pancreaticoduodenectomy plus hemihepatectomy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Sakamoto |
Organization
Graduate School of Medicine, University of Tokyo
Division name
Hepato-Biliary-Pancreatic Surgery Divison, Artificial organ and Liver transplantation Division, Department of Surgery,
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoji Kishi |
Organization
National Cancer Center Hospital
Division name
Hepatobiliary and Pancreatic Surgery Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
yokishi@ncc.go.jp
Sponsor or person
Institute
"Objective evaluation & study of effect of Hepatobiliary and Pancreatic Surgery Technique, and reconstruction of minimally invasive surgery for HBP malignancy" (Shimada Group"
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research from the Ministry of Health and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
国立がん研究センター中央病院、癌研究会附属有明病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 19 | 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
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 18 | Day |
Last modified on
| 2013 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006481
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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| Registered date | File name |
