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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023237
Receipt No. 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

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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
Email 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
Email fjt@med.nagoya-u.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026775

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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