Textbook and Survival Outcomes of MIPD in South Korea

Sponsor
Asan Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT05975710
Collaborator
(none)
1,552
1
35
44.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1552 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Textbook and Survival Outcomes of Minimally Invasive Pancreatoduodenectomy : A Retrospective Multicenter Analysis of 1,552 Patients in Korean Study Group on Minimally Invasive Pancreatic Surgery (K-MIPS)
    Actual Study Start Date :
    Apr 1, 2020
    Actual Primary Completion Date :
    Dec 31, 2022
    Actual Study Completion Date :
    Mar 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Success rate of textbook outcome of pancreatic surgery [3 months]

      If none of the seven specified factors (1. postoperative pancreatic fistula, 2. bile leakage, 3. postpancreatectomy hemorrhage, 4. Clavien-Dindo 3 or higher of complications, 5. readmission within 90 days, 6. in-hospital or 90-day mortality, 7. postoperative hospital stay of more than 14 days) occur after minimally invasive pancreatoduodenectomy, it is defined as TOPS success in current study. In other words, a patient's outcome is considered successful if they do not experience any of these adverse events or complications within the specified time frames.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

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

    Exclusion Criteria:

    None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan medical center Seoul Korea, Republic of 05505

    Sponsors and Collaborators

    • Asan Medical Center

    Investigators

    • Principal Investigator: Song Cheol Kim, MD.PhD, Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Song Cheol Kim, Professor, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT05975710
    Other Study ID Numbers:
    • KMIPS
    First Posted:
    Aug 4, 2023
    Last Update Posted:
    Aug 4, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Aug 4, 2023