UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	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	Hiroki Yamaue
Organization	Wakayama Medical University
Division name	Second Department of Surgery
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	Tsutomu Fujii
Organization	Nagoya University Graduate School of Medicine
Division name	Gastroenterological Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000026775