UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042217 |
|---|---|
| Receipt number | R000048192 |
| Scientific Title | A Multicenter, single-blind, randomized, parallel-group trial comparing stapler closure with Clip on Staple method with stapler closure alone during Distal Pancreatectomy |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2022/04/25 09:50:53 |
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Basic information
Public title
A Multicenter, single-blind, randomized, parallel-group trial comparing stapler closure with Clip on Staple method with stapler closure alone during Distal Pancreatectomy
Acronym
CLIP-DP trial
Scientific Title
A Multicenter, single-blind, randomized, parallel-group trial comparing stapler closure with Clip on Staple method with stapler closure alone during Distal Pancreatectomy
Scientific Title:Acronym
CLIP-DP trial
Region
| Japan |
Condition
Condition
Patients who undergo distal pancreatectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of the Clip on Staple method combined with stapler closure with stapler closure alone during distal pancreatectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The incidence of clinically-relevant pancreatic fistula(ISGPF GradeB/C) or death due to any cause within 30 days after surgery.
Key secondary outcomes
<Secondary endpoints>
The incidence of following complications within 30 days after surgery.
_Pancreatic fistula(ISGPF BL/GradeB/C)
_Postpancreatectomy hemorrhage(PPH)
_Intra-abdominal abscess
_Delayed gastric emptying
_Complications(Clavien-Dindo classification, CD>=Grade3)
_Percutaneous or Endoscopic drainage
Duration of drainage tube placement
Postoperative hospital stay
Operative time/Blood loss
Re-operation within 90 days
Mortality within 90 days
<Exploratory endpoints>
The incidence of clinically-relevant pancreatic fistula according to the thickness of the pancreas(<=12mm/>12mm)
The incidence of pancreatic parenchymal injury after clipping(Central review of intraoperative photography)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Reinforced stapler + Clip on Staple method
Interventions/Control_2
Reinforced stapler
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)Elective distal pancreatectomy(open/laparoscopic/laparoscope-assisted/robot assisted) for disease of the pancreatic body and tail.
*Spleen-preserving DP, RAMPS, DP with combined resection of surrounding organs(e.g. DP-CAR) are also included.
2)The thickness of the pancreatic cutting line on preoperative images are equal or less than 20mm.
3)ECOG Performance Status is 0-1.
4)Aged 20 years old or older.
5)Function of the major organs are maintained.
6)Following criteria are fulfilled in the recent laboratory tests within 30 days from registration.
A)White Blood Cells >= 2,500/mm3
B)Haemoglobin levels >= 9.0 g/dL
C)Platelet counts >= 100,000/mm3
D)Albumin levels >= 3.0 g/dL
E)Total Bilirubin levels <= 2.0 mg/dL
F)Creatinine levels <= 2.0 mg/dL
7)Sufficient understanding of the study to provide written informed consent.
Key exclusion criteria
1)Superior mesenteric vein or portal vein invasion on preoperative images.
2)Planned cutting line of the pancreas is right side of the superior mesenteric vein or portal vein.
3)Use of stapling device is inappropriate.
4)Presence of inoperable factors such as peritoneal dissemination, invasion to major vessels, or liver metastases.
5)Emergent cases.
6)Severe cardiac diseases(NYHA>=3).
7)Need for daily oxygen supply due to severe pulmonary diseases.
8)On maintenance hemodialysis due to chronic renal failure.
9)Allergy to metals.
10)Considered as inappropriate by attending physician.
Target sample size
188
Research contact person
Name of lead principal investigator
| 1st name | Mizuki |
| Middle name | |
| Last name | Ninomiya |
Organization
Fukuoka City Hospital
Division name
Department of Liver Surgery
Zip code
812-0046
Address
13-1,Yoshizuka Hon-machi, Hakata-ku, Fukuoka, 812-0046, Japan
TEL
092-632-1111
nino0401@icloud.com
Public contact
Name of contact person
| 1st name | Mizuki |
| Middle name | |
| Last name | Ninomiya |
Organization
Fukuoka City Hospital
Division name
Department of Liver Surgery
Zip code
812-0046
Address
13-1,Yoshizuka Hon-machi, Hakata-ku, Fukuoka, 812-0046, Japan
TEL
092-632-1111
Homepage URL
nino0401@icloud.com
Sponsor or person
Institute
Kyushu Study group of Clinical Cancer (KSCC)
Institute
Department
Personal name
Funding Source
Organization
Applying for research grant from non-profit foundation.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fukuoka City Hospital
Address
13-1,Yoshizuka Hon-machi, Hakata-ku, Fukuoka, 812-0046, Japan
Tel
092-632-1403
yamada.sa@fcho.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
九州大学病院（福岡県）
独立行政法人国立病院機構九州がんセンター（福岡県）
済生会福岡総合病院（福岡県）
地方独立行政法人福岡市立病院機構福岡市民病院（福岡県）
独立行政法人国立病院機構福岡東医療センター（福岡県）
社会医療法人製鉄記念八幡病院（福岡県）
飯塚病院（福岡県）
大分県立病院（大分県）
大分赤十字病院（大分県）
独立行政法人国立病院機構別府医療センター（大分県）
中津市立中津市民病院（大分県）
松山赤十字病院（愛媛県）
広島赤十字・原爆病院（広島県）
済生会唐津病院（佐賀県）
熊本大学病院（熊本県）
済生会熊本病院（熊本県）
徳島大学病院（徳島県）
群馬大学医学部附属病院（群馬県）
信州大学医学部附属病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.ks-cc.jp
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
| 2020 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 01 | 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
| 2020 | Year | 10 | Month | 23 | Day |
Last modified on
| 2022 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048192
| Research Plan | |
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| 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 |
