UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015943 |
|---|---|
| Receipt number | R000012884 |
| Scientific Title | Horizontal matress suture vs interrupted suture in surgical techniques of pancreaticojejunostomy -randomized clinical trial- |
| Date of disclosure of the study information | 2014/12/14 |
| Last modified on | 2018/06/17 10:52:31 |
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Basic information
Public title
Horizontal matress suture vs interrupted suture in surgical techniques of pancreaticojejunostomy -randomized clinical trial-
Acronym
Horizontal Matress vs interrupted suture in surgical techniques of pancreaticojejunostomy
Scientific Title
Horizontal matress suture vs interrupted suture in surgical techniques of pancreaticojejunostomy -randomized clinical trial-
Scientific Title:Acronym
Horizontal Matress vs interrupted suture in surgical techniques of pancreaticojejunostomy
Region
| Japan |
Condition
Condition
Patients who undergo pancreatoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to verify that the frequency of pancreatic fistula (ISGPF grade B and C) in horizontal matress suture are lower than in interrupted suture during pancreaticojejunostomy by RCT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of pancreatic fistula including ISGPF grade B and C
Key secondary outcomes
Perioperative factors, the rates of postoperative complications, the degree of atrophy in the remnant pancreas, postoperative endocrine and exocrine pancreatic function, frequency of pancreatic fistula including ISGPF grade A, B, and C, time during pancreticojejunostomy, cost of suture required for pancreaticojejunostomy
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
horizontal matress suture in pancreaticojejunostomy n=95
Interventions/Control_2
interrupted suture in pancreaticojejunostomy n=95
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients from whom we obtained written informed consent of this study.
Key exclusion criteria
Patients with severe ischemic cardiac disease, patients with severe liver damage, patients requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis, patients requiring dialysis treatment due to chronic renal failure, or patients who are considered as inappropriate by attendig physician
Target sample size
224
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiko Hirono |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama 641-8510, Japan
TEL
+81-73-441-0613
seiko-h@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiko Hirono |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama 641-8510, Japan
TEL
+81-73-441-0613
Homepage URL
seiko-h@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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 | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 14 | Day |
Last modified on
| 2018 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012884
