UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023237 |
|---|---|
| Receipt number | R000026775 |
| Scientific Title | Comparison of resection during distal pancreatectomy of the splenic vein either together with the pancreatic parenchyma or after isolation: A multicentre, prospective, randomized phase III trial (COSMOS-DP trial) |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2018/01/19 10:00:46 |
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Basic information
Public title
Comparison of resection during distal pancreatectomy of the splenic vein either together with the pancreatic parenchyma or after isolation: A multicentre, prospective, randomized phase III trial (COSMOS-DP trial)
Acronym
COSMOS-DP trial
Scientific Title
Comparison of resection during distal pancreatectomy of the splenic vein either together with the pancreatic parenchyma or after isolation: A multicentre, prospective, randomized phase III trial (COSMOS-DP trial)
Scientific Title:Acronym
COSMOS-DP trial
Region
| Japan |
Condition
Condition
pancreatic body and tail tumor including cancer, intraductal-papillary mucinous neoplasm, neuroendocrine tumour, mucinous cystic neoplasm, or metastatic pancreatic tumour
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of the COSMOS-DP trial is to confirm the non-inferiority of resection of the splenic vein embedded in the pancreatic parenchyma compared with the conventional technique of isolating the splenic vein before resection during DP using a mechanical stapler.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
the primary endpoint is the incidence of PF (ISGPF grade B/C)
Key secondary outcomes
The secondary endpoints are as follows: outcome measures related to surgery, such as the operative time, volume of blood loss, preoperative thickness of the resected pancreatic parenchyma, haemostasis of the staple line, integrity of the staple line, incidence of pancreatic injury, need for additional sutures to securely close the pancreatic stump, time needed for pancreatic transection, number of resected branches from the splenic vein, duration of drainage tube placement, postoperative hospital stay duration, and incidence of conversion from laparoscopic surgery to open surgery. The outcome measures related to complications include the incidence of PFs of all grades, incidence of grade C PF, incidence of intra-abdominal haemorrhage, incidence of all complications, comparison of the thickness of the resected pancreatic parenchyma with the incidence of PF grade B/C, mortality, and incidence of thrombosis of the splenic vein (at 1 and 6 months after surgery).
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
resection of the splenic vein after isolation from the pancreatic parenchyma
Interventions/Control_2
co-resection of the vein together with the pancreas
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
(i) Elective open or laparoscopic distal pancreatectomy for diseases of the pancreatic body and tail
(ii) ECOG Performance Status (PS)=0-1
(iii)Aged 20 years or older
(iv) Maintenance of functioning of the major organs (bone marrow, liver, kidney, lung, etc.)
(a) White blood cells >2,500/mm3
(b) Haemoglobin >9.0 g/dL
(c) platelets >100,000/mm3
(d) Total bilirubin <2.0 mg/dL
(e) Creatinine <2.0 mg/dL
(v) Sufficient judgement to understand the study and to provide written informed consent
Key exclusion criteria
(i) Splenic vein-preserving distal pancreatectomy
(ii) Superior mesenteric vein or portal vein invasion
(iii) Pancreatic trauma
(iv) Preoperative inflammatory pancreatic disease (pancreatitis)
(v) Requirement of anti-coagulant treatment during or after surgery*
(vi) Severe ischemic cardiovascular disease
(vii) Liver cirrhosis or active hepatitis
(viii) Need for oxygen due to interstitial pneumonia or lung fibrosis
(ix) Dialysis due to chronic renal failure
(x) Need for surrounding organ resection (stomach, colon, etc.),excluding the left adrenal gland and gall bladder
(xi) Active multiple cancer that is thought to influence the occurrence of adverse events
(xii) Difficulty with study participation due to psychotic disease or symptoms
(xiii) Inappropriate use of the stapler
(xiv) Inappropriate for the study objectives
* Anti-coagulant treatment at 24 hrs after surgery is allowed.
Target sample size
304
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Yamaue |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama , Wakayama Prefecture, 641-8510
TEL
073-441-0613
yamaue-h@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Fujii |
Organization
Nagoya University Graduate School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550
TEL
052-744-2249
Homepage URL
fjt@med.nagoya-u.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 08 | Month | 01 | 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
| 2016 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 19 | Day |
Last modified on
| 2018 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026775
