Surgery-ComplicationsNCT05975710
Textbook and Survival Outcomes of MIPD in South Korea
An observational study of Surgery-Complications, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery-Complications
- How many people
- 1,552 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2020to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: This retrospective multicenter cohort study evaluated 1,552 patients who underwent MIPD by 24 experienced pancreatic surgeons between May 2007 and April 2020 at ten tertiary referral institutions in South Korea. The research was conducted using data registered in the registry of the Korean study group on Minimally Invasive Pancreatic Surgery (K-MIPS). The consecutive patient's data were recorded retrospectively and self-registered at each institution.
Who may be able to join
- The patients who underwent MIPD between May 2007 and April 2020 at ten tertiary referral institutions in South Korea.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of textbook outcome of pancreatic surgery
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Apr 2020
- Primary completion31 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery-ComplicationsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Cheol Kim, Asan Medical Center
- Investigators
- Song Cheol Kim, MD.PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975710
- Sponsor's protocol ID
- KMIPS
- Status last verified
- Aug 2023
- First submitted
- 15 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05975710
- Acronym / sponsor ID
- KMIPS
- Conditions
- Surgery-Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,552 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective multicenter cohort study evaluated 1,552 patients who underwent MIPD by 24 experienced pancreatic surgeons between May 2007 and April 2020 at ten tertiary referral institutions in South Korea. The research was conducted using data registered in the registry of the Korean study group on Minimally Invasive Pancreatic Surgery (K-MIPS). The consecutive patient's data were recorded retrospectively and self-registered at each institution.
Key inclusion criteria (1 listed)
- The patients who underwent MIPD between May 2007 and April 2020 at ten tertiary referral institutions in South Korea.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Success rate of textbook outcome of pancreatic surgery
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Song Cheol Kim, MD.PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery-Complications, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of textbook outcome of pancreatic surgery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.