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

Toshio Shimokawa¹  Yasuhiro Kodera²  Suguru Yamada²  Hidetoshi Eguchi³  Masafumi Nakamura⁴  Tsutomu Fujii⁵  Yoshiaki Murakami⁶  Sohei Satoi⁷  Yuichi Nagakawa⁸  Hiroki Yamaue⁹  Manabu Kawai⁹ 

[1] Clinical Study Support Centre, Wakayama Medical University;Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine;Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine;Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University;Department of Surgery and Science, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama;Department of Surgery, Institute of Biomedical and Health Sciences, Hiroshima University;Department of Surgery, Kansai Medical University;Department of Surgery, Tokyo Medical University;Second Department of Surgery, Wakayama Medical University;

关键词: Distal pancreatectomy;    Splenic vein;    Intra-abdominal haemorrhage;    Pancreatic fistula;    Mechanical stapler;   

DOI  :  10.1186/s13063-018-2756-7

来源: DOAJ

【 摘 要 】

Abstract 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. Trial registration ClinicalTrials.gov, NCT02871804. Registered on 27 July 2016.

【 授权许可】

Unknown