UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000952 |
|---|---|
| Receipt number | R000001133 |
| Scientific Title | A preventive effect of pancreatic duct stenting to decrease the rate of pancreatic fistula after pancreaticojejunostomy following pancreatoduodenectomy |
| Date of disclosure of the study information | 2007/12/20 |
| Last modified on | 2013/08/01 18:28:37 |
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Basic information
Public title
A preventive effect of pancreatic duct stenting to decrease the rate of pancreatic fistula after pancreaticojejunostomy following pancreatoduodenectomy
Acronym
A preventive effect of pancreatic duct stenting to decrease the rate of pancreatic fistula after pancreaticojejunostomy
Scientific Title
A preventive effect of pancreatic duct stenting to decrease the rate of pancreatic fistula after pancreaticojejunostomy following pancreatoduodenectomy
Scientific Title:Acronym
A preventive effect of pancreatic duct stenting to decrease the rate of pancreatic fistula after pancreaticojejunostomy
Region
| Japan |
Condition
Condition
pancreatoduodenectomy for pancreatic head cancer, bile duct cancer, cancer of the Vater's papilla, gallbladder cancer, pancreatic head tumor (Intraductal papillary-mucinous neoplasm, endocrine tumor, other pancreatic tumor), chronic pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To invstigate the preventive effect of pancreatic duct stenting to decrease the pancreatic fistula after pancreaticojejunostomy following pancreatoduodenectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
Rate and severity of pancreatic fistula
Key secondary outcomes
postoperative morbidity rate, postoperative hospital stay, hospital mortality rate
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
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Stented group
Interventions/Control_2
Nonstented group
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)all adult patient who are anticipate to undergo pancreatoduodenectomy
2)reconstruction feasible for pancreaticojejunostomy
3) written informed consent
Key exclusion criteria
1)requiring total pancreatectomy
2)unfeasible for pancreaticojejunostomy
3)past history for pancreatectomy
4)other unfeasible factors to study safety, approved attending surgeon
5)pregnancy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Unno Michiaki |
Organization
Tohoku University Hospital
Division name
Hepato-Biliary Pancreatic surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoi Fuyuhiko |
Organization
Tohoku University Hospital
Division name
Hepato-Biliary Pancreatic surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
Homepage URL
fmotoi@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Department of surgery, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
None (self-funding)
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 12 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/
Number of participants that the trial has enrolled
Results
The rate of clinically relevant POPF was significantly lower in the stented group than in the non-stented group: three of 47 (6 per cent) versus ten of 46 (22 per cent) (P = 0.040). Among patients with a dilated duct, rates of POPF were similar in both groups. Among patients with a non-dilated duct, clinically relevant POPF was significantly less common in the stented group than the non-stented group: two of 21 (10 per cent) versus eight of 20 (40 per cent) (P = 0.033).
Univariable analysis identified body mass index (BMI), pancreatic cancer, pancreatic texture, pancreatic duct size and duct stenting as risk factors related to clinically relevant POPF. Multivariable analysis taking these five factors into account identified high BMI (risk ratio (RR) 11.4; P = 0.009), non-dilated duct (RR 5.33; P = 0.047) and no stent (RR 10.4; P = 0.004) as significant risk factors.
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
| 2007 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 12 | Month | 20 | Day |
Last modified on
| 2013 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001133
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/06/15 | Br J 2012 Motoi F.xlsx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
