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

Pancreatic Neoplasms Clinical Trial

— COSMOS-DP  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02871804
• Other study ID #: COSMOS-DP trial
• Status: Recruiting
• Phase: Phase 3
• First received: July 27, 2016
• Last updated: August 15, 2016
• Start date: August 2016
• Est. completion date: February 2020

Study information

• Verified date: August 2016
• Source: Wakayama Medical University
• Contact: Hiroki Yamaue, MD, PhD
• Phone: +81-73-441-0613
• Email: yamaue-h[@]wakayama-med.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: February 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Procedure:
• 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 from the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers.

Locations

Country	Name	City	State
Japan	Wakayama Medical University	Wakayama

Sponsors (1)

Lead Sponsor	Collaborator
Wakayama Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of pancreatic fsitula grade B/C		6 months after operation	No
Secondary	the incidence of pancreatic fsitula of all grades		6 months after operation	No
Secondary	the incidence of pancreatic fsitula grade C		6 months after operation	No
Secondary	the incidenceof intra-abdominal haemorrhage		6 months after operation	No
Secondary	the incidence of all complications		6 months after operation	No
Secondary	comparison of the thickness of the resected pancreatic parenchyma with the incidence of PF grade B/C		6 months after operation	No
Secondary	mortality		6 months after operation	No
Secondary	the incidence of thrombosis of the splenic vein		6 months after operation	No
Secondary	the operative time		during operation	No
Secondary	volume of blood loss		during operation	No
Secondary	thickness of the resected pancreatic parenchyma		during operation	No
Secondary	haemostasis of the staple line		during operation	No
Secondary	integrity of the staple line		during operation	No
Secondary	the incidence of pancreatic injury		during operation	No
Secondary	need for additional sutures to securely close the pancreatic stump		during operation	No
Secondary	time needed for pancreatic transection		during operation	No
Secondary	duration of drainage tube placement		6 months after operation	No
Secondary	postoperative hospital stay duration		6 months after operation	No
Secondary	the incidence of conversion from laparoscopic surgery to open surgery		during operation	No