Combined Resection vs. Separated Resection After Mobilization of Splenic Vein During Distal Pancreatectomy (COSMOS-DP)

Wakayama Medical University

Status and phase: Unknown; Phase 3

Conditions: Pancreatic Neoplasms

Treatments: Procedure: combined resection of the splenic vein; Procedure: separated resection of the splenic vein

Study type: Interventional

Funder types: Other

Identifiers

NCT02871804

COSMOS-DP trial

Details and patient eligibility

About

Eligible patients will be centrally randomized to either Arm A (resection of the splenic vein after isolation from the pancreatic parenchyma) or Arm B (co-resection of the vein together with the pancreas).

Full description

In distal pancreatectomy, it is customary to ligate and divide the splenic vein after isolating it from the pancreatic parenchyma. This is considered essential to prevent disruption of the stump of the splenic vein and the consequent intra-abdominal haemorrhage in the event of pancreatic fistula. This procedure can be technically demanding, especially when the vein is firmly embedded in the pancreatic parenchyma. The objective of this 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 distal pancreatectomy using a mechanical stapler.

Enrollment: 304 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective open or laparoscopic distal pancreatectomy for diseases of the pancreatic body and tail
• ECOG Performance Status (PS) = 0-1
• Age ≥ 20 years old
• 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

Exclusion criteria

• Splenic vein-preserving distal pancreatectomy
• Superior mesenteric vein or portal vein invasion
• Pancreatic trauma
• Preoperative inflammatory pancreatic disease (pancreatitis)
• Requirement of anti-coagulant treatment during or after surgery. Anti-coagulant treatment at 24 hrs after surgery is allowed.
• Severe ischemic cardiovascular disease
• Liver cirrhosis or active hepatitis
• Need for oxygen due to interstitial pneumonia or lung fibrosis
• Dialysis due to chronic renal failure
• Need for surrounding organ resection (stomach, colon, etc.), excluding the left adrenal gland and gall bladder
• Active multiple cancer that is thought to influence the occurrence of adverse events
• Difficulty with study participation due to psychotic disease or symptoms
• Inappropriate use of the stapler
• Inappropriate for the study objectives

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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304 participants in 2 patient groups

separated resection of the splenic vein

Active Comparator group

Description:

separated resection of the splenic vein from the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers.

Treatment:

Procedure: separated resection of the splenic vein

combined resection of the splenic vein

Experimental group

Description:

combined resection of the splenic vein with the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers.

Treatment:

Procedure: combined resection of the splenic vein