Combined Resection vs. Separated Resection After Mobilization of Splenic Vein During Distal Pancreatectomy

Phase 3

• Conditions: Pancreatic Neoplasms
• Interventions: Procedure: combined resection of the splenic vein; Procedure: separated resection of the splenic vein

• Registration Number: NCT02871804
• Lead Sponsor: Wakayama Medical University

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2016-07-27
• Status Verified: 2016-08
• Study Start: 2016-08
• Study First Submitted QC: 2016-08-15
• Last Update Submitted: 2016-08-15
• Study First Posted: 2016-08-18
• Last Update Posted: 2016-08-18
• Primary Completion: 2019-08
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 304

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
the incidence of pancreatic fsitula grade B/C	6 months after operation

Secondary Outcome Measures

Name	Time	Method
thickness of the resected pancreatic parenchyma	during operation
haemostasis of the staple line	during operation
the incidence of pancreatic injury	during operation
need for additional sutures to securely close the pancreatic stump	during operation
duration of drainage tube placement	6 months after operation
the incidence of pancreatic fsitula of all grades	6 months after operation
the incidence of thrombosis of the splenic vein	6 months after operation
integrity of the staple line	during operation
mortality	6 months after operation
the operative time	during operation
postoperative hospital stay duration	6 months after operation
the incidence of conversion from laparoscopic surgery to open surgery	during operation
the incidence of pancreatic fsitula grade C	6 months after operation
volume of blood loss	during operation
the incidenceof intra-abdominal haemorrhage	6 months after operation
the incidence of all complications	6 months after operation
comparison of the thickness of the resected pancreatic parenchyma with the incidence of PF grade B/C	6 months after operation
time needed for pancreatic transection	during operation

Trial Locations

Locations (1)

Wakayama Medical University; 🇯🇵 Wakayama, Japan