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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of pancreatic fsitula grade B/C | 6 months after operation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hiroki Yamaue, MD, PhD | Contact | +81-73-441-0613 | yamaue-h@wakayama-med.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Hiroki Yamaue, MD, PhD | Wakayama Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wakayama Medical University | Recruiting | Wakayama | 641-8510 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33656542 | Derived | 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. | |
| 29996884 |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| 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. |
|
| 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 |
| 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. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |