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)
- Conditions
- pancreatic body and tail tumor including cancer, intraductal-papillary mucinous neoplasm, neuroendocrine tumour, mucinous cystic neoplasm, or metastatic pancreatic tumour
- Registration Number
- JPRN-UMIN000023237
- Lead Sponsor
- Wakayama Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 304
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the primary endpoint is the incidence of PF (ISGPF grade B/C)
- Secondary Outcome Measures
Name Time Method 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).