Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05975710
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2023-07-15
Brief Title:
Textbook and Survival Outcomes of MIPD in South Korea
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
Textbook and Survival Outcomes of Minimally Invasive Pancreatoduodenectomy A Retrospective Multicenter Analysis of 1552 Patients in Korean Study Group on Minimally Invasive Pancreatic Surgery K-MIPS
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study was to investigate the current status of minimally invasive pancreatoduodenectomy MIPD in South Korea with regard to demographics perioperative outcomes risk factors for textbook outcome of pancreatic surgery TOPS and survival outcomes of periampullary cancer
Detailed Description:
Pancreatoduodenectomy PD is the most complicated abdominal surgical procedure and in addition the difficulty of this operation is much higher if it is performed using minimally invasive methods Since these first minimally invasive pancreatoduodenectomy MIPD surgeries were performed they have been adopted by various institutions and their effectiveness has been highlighted in several studies Advantages of MIPD include a short hospital stay less blood loss and less pain compared to open procedures However a multicenter randomized controlled trial that compared LPD and open pancreatoduodenectomy OPD reported that LPD had a higher complication-related mortality rate than OPD Meta-analysis of randomized controlled trials of LPD versus OPD also reported that LPD had no advantage over OPD but with a high risk of bias and moderate to low level of evidence In a meta-analysis of RPD and OPD RPD was found to have the advantages of less blood loss shorter hospital stay and lower wound infection rate than OPD but to date no studies have reported results for randomized controlled trials of RPD Although it is still early to make generalized conclusions about MIPD due to the selection bias inherent in retrospective studies and an insufficient number of prospective studies the frequency with which MIPD is being performed is gradually increasing Studies on the learning curve of MIPD are currently in progress and one study recommended establishment of an MIPD registry for research purposes South Korea is one of the country leading the implementation of MIPD and several Korean groups have published studies on this surgery and have collaborated to establish a registry in line with global trends After the establishment of the Korean study group on Minimally Invasive Pancreatic Surgery K-MIPS in 2019 httpkmipsorkrindexhtml 1552 MIPD patients were retrospectively enrolled Apart from this the textbook outcomes after surgery was recently emerged as a valuable approach for assessing surgical success as it considers multiple quality measures to provide a comprehensive indication of overall outcomes Recently the Dutch Pancreatic Cancer Group reported about textbook outcome of pancreatic surgery TOPS which is also a multidimensional measure that allows assessment of the quality of surgical outcomes and several papers have investigated textbook outcome after hepatobiliary and pancreatic surgery From this perspective conducting an analysis of the current status of MIPD in Korea and evaluating the surgical outcomes by TOPS would provide valuable insights making this study highly relevant and meaningful The aim of this study was to describe the current status of MIPD in South Korea in terms of demographics perioperative outcomes survival outcomes TOPS and risk factor of TOPS In addition current study compared subgroups classified according to hospital volume in South Korea to determine if hospital volume affects perioperative outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None