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

Suguru Yamada, Tsutomu Fujii, Manabu Kawai, Toshio Shimokawa, Masafumi Nakamura, Yoshiaki Murakami, Sohei Satoi, Hidetoshi Eguchi, Yuichi Nagakawa, Yasuhiro Kodera, Hiroki Yamaue

研究成果: ジャーナルへの寄稿記事

1 引用 (Scopus)

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Background: In distal pancreatectomy (DP), 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 consequent intra-abdominal haemorrhage in the event of pancreatic fistula (PF). However, this procedure can be technically demanding, especially when the vein is firmly embedded in the pancreatic parenchyma. The objective of the COSMOS-DP 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 DP using a mechanical stapler. Methods: Patients with diseases of the pancreatic body and tail whose pancreatic parenchyma and splenic vein can be divided concurrently during open or laparoscopic DP are considered eligible for inclusion. This study is designed as a multicentre prospective randomised phase III trial. Eligible patients will be centrally randomised 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). This study aims to establish the non-inferiority of the safety of Arm B compared with that of Arm A; the primary endpoint is the incidence of PF (ISGPF grade B/C). Discussion: The COSMOS-DP trial will establish the safety of this procedure, such that it can be recommended with more confidence. The use of this procedure will likely result in significant reductions in operative time and blood loss during DP.

元の言語英語
記事番号369
ジャーナルTrials
19
発行部数1
DOI
出版物ステータス出版済み - 7 11 2018

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Splenic Vein
Pancreatectomy
Clinical Protocols
Randomized Controlled Trials
Pancreatic Fistula
Veins
Safety
Pancreatic Diseases
Operative Time
Pancreas
Hemorrhage
Incidence

All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Pharmacology (medical)

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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. / Yamada, Suguru; Fujii, Tsutomu; Kawai, Manabu; Shimokawa, Toshio; Nakamura, Masafumi; Murakami, Yoshiaki; Satoi, Sohei; Eguchi, Hidetoshi; Nagakawa, Yuichi; Kodera, Yasuhiro; Yamaue, Hiroki.

:: Trials, 巻 19, 番号 1, 369, 11.07.2018.

研究成果: ジャーナルへの寄稿記事

Yamada, Suguru ; Fujii, Tsutomu ; Kawai, Manabu ; Shimokawa, Toshio ; Nakamura, Masafumi ; Murakami, Yoshiaki ; Satoi, Sohei ; Eguchi, Hidetoshi ; Nagakawa, Yuichi ; Kodera, Yasuhiro ; Yamaue, Hiroki. / 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 ; 巻 19, 番号 1.
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T1 - Splenic vein resection together with the pancreatic parenchyma versus separated resection after isolation of the parenchyma during distal pancreatectomy (COSMOS-DP trial)

T2 - Study protocol for a randomised controlled trial

AU - Yamada, Suguru

AU - Fujii, Tsutomu

AU - Kawai, Manabu

AU - Shimokawa, Toshio

AU - Nakamura, Masafumi

AU - Murakami, Yoshiaki

AU - Satoi, Sohei

AU - Eguchi, Hidetoshi

AU - Nagakawa, Yuichi

AU - Kodera, Yasuhiro

AU - Yamaue, Hiroki

PY - 2018/7/11

Y1 - 2018/7/11

N2 - Background: In distal pancreatectomy (DP), 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 consequent intra-abdominal haemorrhage in the event of pancreatic fistula (PF). However, this procedure can be technically demanding, especially when the vein is firmly embedded in the pancreatic parenchyma. The objective of the COSMOS-DP 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 DP using a mechanical stapler. Methods: Patients with diseases of the pancreatic body and tail whose pancreatic parenchyma and splenic vein can be divided concurrently during open or laparoscopic DP are considered eligible for inclusion. This study is designed as a multicentre prospective randomised phase III trial. Eligible patients will be centrally randomised 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). This study aims to establish the non-inferiority of the safety of Arm B compared with that of Arm A; the primary endpoint is the incidence of PF (ISGPF grade B/C). Discussion: The COSMOS-DP trial will establish the safety of this procedure, such that it can be recommended with more confidence. The use of this procedure will likely result in significant reductions in operative time and blood loss during DP.

AB - Background: In distal pancreatectomy (DP), 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 consequent intra-abdominal haemorrhage in the event of pancreatic fistula (PF). However, this procedure can be technically demanding, especially when the vein is firmly embedded in the pancreatic parenchyma. The objective of the COSMOS-DP 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 DP using a mechanical stapler. Methods: Patients with diseases of the pancreatic body and tail whose pancreatic parenchyma and splenic vein can be divided concurrently during open or laparoscopic DP are considered eligible for inclusion. This study is designed as a multicentre prospective randomised phase III trial. Eligible patients will be centrally randomised 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). This study aims to establish the non-inferiority of the safety of Arm B compared with that of Arm A; the primary endpoint is the incidence of PF (ISGPF grade B/C). Discussion: The COSMOS-DP trial will establish the safety of this procedure, such that it can be recommended with more confidence. The use of this procedure will likely result in significant reductions in operative time and blood loss during DP.

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