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

Primary Purpose

Pancreatic Neoplasms

Status

Unknown status

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

combined resection of the splenic vein

separated resection of the splenic vein

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Wakayama Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

separated resection of the splenic vein

combined resection of the splenic vein

Arm Description

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

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

Outcomes

Primary Outcome Measures

the incidence of pancreatic fsitula grade B/C

Secondary Outcome Measures

the incidence of pancreatic fsitula of all grades

the incidence of pancreatic fsitula grade C

the incidenceof intra-abdominal haemorrhage

the incidence of all complications

comparison of the thickness of the resected pancreatic parenchyma with the incidence of PF grade B/C

mortality

the incidence of thrombosis of the splenic vein

the operative time

volume of blood loss

thickness of the resected pancreatic parenchyma

haemostasis of the staple line

integrity of the staple line

the incidence of pancreatic injury

need for additional sutures to securely close the pancreatic stump

time needed for pancreatic transection

duration of drainage tube placement

postoperative hospital stay duration

the incidence of conversion from laparoscopic surgery to open surgery

Full Information

NCT ID

NCT02871804

First Posted

July 27, 2016

Last Updated

August 15, 2016

Sponsor

Wakayama Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02871804

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2016 (undefined)

Primary Completion Date

August 2019 (Anticipated)

Study Completion Date

February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wakayama Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

separated resection of the splenic vein

Arm Type

Active Comparator

Arm Description

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

Arm Title

combined resection of the splenic vein

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

combined resection of the splenic vein

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

separated resection of the splenic vein

Intervention Description

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

Primary Outcome Measure Information:

Title

the incidence of pancreatic fsitula grade B/C

Time Frame

6 months after operation

Secondary Outcome Measure Information:

Title

the incidence of pancreatic fsitula of all grades

Time Frame

6 months after operation

Title

the incidence of pancreatic fsitula grade C

Time Frame

6 months after operation

Title

the incidenceof intra-abdominal haemorrhage

Time Frame

6 months after operation

Title

the incidence of all complications

Time Frame

6 months after operation

Title

comparison of the thickness of the resected pancreatic parenchyma with the incidence of PF grade B/C

Time Frame

6 months after operation

Title

mortality

Time Frame

6 months after operation

Title

the incidence of thrombosis of the splenic vein

Time Frame

6 months after operation

Title

the operative time

Time Frame

during operation

Title

volume of blood loss

Time Frame

during operation

Title

thickness of the resected pancreatic parenchyma

Time Frame

during operation

Title

haemostasis of the staple line

Time Frame

during operation

Title

integrity of the staple line

Time Frame

during operation

Title

the incidence of pancreatic injury

Time Frame

during operation

Title

need for additional sutures to securely close the pancreatic stump

Time Frame

during operation

Title

time needed for pancreatic transection

Time Frame

during operation

Title

duration of drainage tube placement

Time Frame

6 months after operation

Title

postoperative hospital stay duration

Time Frame

6 months after operation

Title

the incidence of conversion from laparoscopic surgery to open surgery

Time Frame

during operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hiroki Yamaue, MD, PhD

Phone

+81-73-441-0613

yamaue-h@wakayama-med.ac.jp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hiroki Yamaue, MD, PhD

Organizational Affiliation

Wakayama Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wakayama Medical University

City

Wakayama

ZIP/Postal Code

641-8510

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hiroki Yamaue, MD, PhD

Phone

+81-73-441-0613

yamaue-h@wakayama-med.ac.jp

First Name & Middle Initial & Last Name & Degree

Tsutomu Fujii, MD, PhD

First Name & Middle Initial & Last Name & Degree

Manabu Kawai, MD, PhD

First Name & Middle Initial & Last Name & Degree

Suguru Yamada, MD, PhD

First Name & Middle Initial & Last Name & Degree

Yuichi Nagakawa, MD, PhD

First Name & Middle Initial & Last Name & Degree

Sohei Satoi, MD, PhD

First Name & Middle Initial & Last Name & Degree

Hidetoshi Eguchi, MD, PhD

First Name & Middle Initial & Last Name & Degree

Yoshiaki Murakami, MD, PhD

First Name & Middle Initial & Last Name & Degree

Masafumi Nakamura, MD, PhD

First Name & Middle Initial & Last Name & Degree

Toshio Shimokawa, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33656542

Citation

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.

Results Reference

derived

PubMed Identifier

29996884

Citation

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.

Results Reference

derived

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

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