Combined Resection Vs. Separated Resection After Mobilization Of Splenic Vein During Distal Pancreatectomy

Study Overview

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

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).

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.

Pancreatic Neoplasms

PROCEDURE: combined resection of the splenic vein
PROCEDURE: separated resection of the splenic vein

COSMOS-DP trial

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-07-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-08-15
First Submitted that Met QC Criteria 2016-08-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-08-18
First Posted (ESTIMATED) 2016-08-18	Results First Posted N/A	Last Verified 2016-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: 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.	PROCEDURE: 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.
EXPERIMENTAL: 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.	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.

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: 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.

PROCEDURE: 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.

EXPERIMENTAL: 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.

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.

Primary Outcome Measures	Measure Description	Time Frame
the incidence of pancreatic fsitula grade B/C		6 months after operation

Secondary Outcome Measures	Measure Description	Time Frame
the incidence of pancreatic fsitula of all grades		6 months after operation
the incidence of pancreatic fsitula grade C		6 months after 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
mortality		6 months after operation
the incidence of thrombosis of the splenic vein		6 months after operation
the operative time		during operation
volume of blood loss		during operation
thickness of the resected pancreatic parenchyma		during operation
haemostasis of the staple line		during operation
integrity 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
time needed for pancreatic transection		during operation
duration of drainage tube placement		6 months after operation
postoperative hospital stay duration		6 months after operation
the incidence of conversion from laparoscopic surgery to open surgery		during operation

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Hiroki Yamaue, MD, PhD

Phone Number: +81-73-441-0613

Email: yamaue-h@wakayama-med.ac.jp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Hiroki Yamaue, MD, PhD, Wakayama Medical University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Yamada S, Fujii T, Sonohara F, Kawai M, Shibuya K, Matsumoto I, Fukuzawa K, Baba H, Aoki T, Unno M, Satoi S, Kishi Y, Hatano E, Uemura K, Horiguchi A, Sho M, Takeda Y, Shimokawa T, Kodera Y, Yamaue H. Safety of Combined Division vs Separate Division of the Splenic Vein in Patients Undergoing Distal Pancreatectomy: A Noninferiority Randomized Clinical Trial. JAMA Surg. 2021 May 1;156(5):418-428. doi: 10.1001/jamasurg.2021.0108.
Yamada S, Fujii T, Kawai M, Shimokawa T, Nakamura M, Murakami Y, Satoi S, Eguchi H, Nagakawa Y, Kodera Y, Yamaue H. Splenic vein resection together with the pancreatic parenchyma versus separated resection after isolation of the parenchyma during distal pancreatectomy (COSMOS-DP trial): study protocol for a randomised controlled trial. Trials. 2018 Jul 11;19(1):369. doi: 10.1186/s13063-018-2756-7.

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