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

NCT02871804 | Unknown Phase 3 DMC

• 1 other identifier: COSMOS-DP trial
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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).

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• the incidence of pancreatic fsitula grade B/C

  6 months after operation

Secondary Outcomes (18)

• 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

Study Arms (2)

separated resection of the splenic vein

ACTIVE COMPARATOR

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

combined resection of the splenic vein

EXPERIMENTAL

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

Interventions

combined resection of the splenic vein PROCEDURE

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

combined resection of the splenic vein

separated resection of the splenic vein PROCEDURE

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

separated resection of the splenic vein

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wakayama Medical University: lead

Study Sites (1)

Wakayama Medical University

Wakayama, 641-8510, Japan

RECRUITING

Related Publications (2)

• 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.

  PMID: 33656542 DERIVED

• 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.

  PMID: 29996884 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Hiroki Yamaue, MD, PhD

  Wakayama Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hiroki Yamaue, MD, PhD

CONTACT

+81-73-441-0613; yamaue-h@wakayama-med.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: August 18, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: February 1, 2020
• Last Updated: August 18, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)