Textbook and Survival Outcomes of MIPD in South Korea

NCT ID: NCT05975710

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1552 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2023-03-01

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 (http://kmips.or.kr/index.html), 1,552 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.

Conditions

Surgery-Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

The patients who underwent MIPD between May 2007 and April 2020 at ten tertiary referral institutions in South Korea.

Exclusion Criteria

None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Song Cheol Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Song Cheol Kim, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan medical center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KMIPS

Identifier Type: -

Identifier Source: org_study_id