UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052089 |
|---|---|
| Receipt number | R000059453 |
| Scientific Title | The safety and efficacy of stapler method for transection of the pancreatic parenchyma during pancreatoduodenectomy (STRAP-PD trial): study protocol for a randomized control trial |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2024/09/01 10:40:48 |
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Basic information
Public title
The safety and efficacy of stapler method for transection of the pancreatic parenchyma during pancreatoduodenectomy (STRAP-PD trial): study protocol for a randomized control trial
Acronym
STRAP-PD trial
Scientific Title
The safety and efficacy of stapler method for transection of the pancreatic parenchyma during pancreatoduodenectomy (STRAP-PD trial): study protocol for a randomized control trial
Scientific Title:Acronym
STRAPP-PD trial
Region
| Japan |
Condition
Condition
Patients with soft pancreas were scheduled to undergo pancreaticoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In a randomized control trial of transecting the pancreatic parenchyma in pancreaticoduodenectomy, a method using an automatic suture device and a conventional transecting method using energy devices such as a scalpel and an ultrasonic coagulator and incision device were investigated. To examine the safety and usefulness of the automatic suture device dissection method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of pancreatic fistula ISGPF grade B or C
Key secondary outcomes
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
| Device,equipment | Maneuver |
Interventions/Control_1
The pancreas was transected using a linear stapler.
Interventions/Control_2
The pancreas was transected using a energy device.
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) Patients judged to have soft pancreas among those scheduled for pancreaticoduodenectomy.
2) The thickness of the pancreatic parenchyma can be cut with surgical stapler.
3) ECOG Performance Status (PS) is 0-1.
4) Age 20 years or older.
5) The functions of major organs (bone marrow, heart, liver, kidneys, lungs, etc.) are maintained.
6) Sufficient judgment to understand the content of the research and providing written informed consent.
Key exclusion criteria
1) Serious ischemic heart disease.
2) Complication of liver cirrhosis or active hepatitis.
3) Dyspnea requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis.
4) Undergoing dialysis for chronic renal failure.
5) Requiring combined resection of surrounding organs.
6) Considered to require arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc.
7) Active double cancers that may affect adverse events or overall survival.
8) Long-term oral steroid use that may cause adverse events.
9) Psychosis or psychiatric symptoms judged to potentially cause difficulty in participation in the study.
10) History of abdominal operation including gastrectomy, colectomy, rectal resection, hepatectomy, but excluding cholecystectomy.
11) Inability to use both iodine-based drugs and gadolinium-based drugs due to serious drug allergies.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kawai |
Organization
Wakayama medical university
Division name
2nd department of surgery
Zip code
641-8510
Address
811-1 Kimiidera Wakayama
TEL
0734410613
kawai@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Kitahata |
Organization
Wakayama medical university
Division name
2nd department of surgery
Zip code
641-8510
Address
811-1 Kimiidera Wakayama
TEL
0734410613
Homepage URL
yuji-kh@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university
Institute
Department
Personal name
Manabu Kawai
Funding Source
Organization
Wakayama medical university
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
Wakayama medical university
Address
811-1 Kimiidera Wakayama
Tel
0734410613
yuji-kh@wakayama-med.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
| 2023 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 09 | Month | 01 | Day |
Last modified on
| 2024 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059453
