Clinical trial · Interventional
Combined Resection vs. Separated Resection After Mobilization of Splenic Vein During Distal Pancreatectomy
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
NCT02871804CI-TRIAL-00023548COSMOS-DPunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| combined resection of the splenic vein | Procedure | — | UNRESOLVED |
| separated resection of the splenic vein | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- separated resection of the splenic vein
- description
- separated resection of the splenic vein from the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers.
- interventionNames
- Procedure: separated resection of the splenic vein
- type
- EXPERIMENTAL
- label
- combined resection of the splenic vein
- description
- combined resection of the splenic vein with the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers.
- interventionNames
- Procedure: combined resection of the splenic vein
Primary outcomes (1)
- measure
- the incidence of pancreatic fsitula grade B/C
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDYamada 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
- DERIVEDYamada 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