Postoperative ComplicationNCT05837793
Modified Frailty Index for Minimally Invasive Distal Pancreatectomy
An observational study of Postoperative Complication, run by Song Cheol Kim at 1 site in South Korea.
Trial summary
This study aims to investigate the difference in postoperative complications according to the modified Frailty Index (mFI) in patients who underwent minimally invasive distal pancreatectomy for pancreatic tumors at the Asan Medical Center's Department of Hepato-Biliary-Pancreatic Surgery from 2005 to 2019. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Complication
- What is being tested?
- Modified frailty index
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2023to 10 Apr 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study aims to investigate the trend of frailty among patients who underwent minimally invasive pancreaticoduodenectomy for pancreatic head tumors between January 2005 and December 2019, using data collected until October 31, 2022. Based on an estimated 150 surgeries per year, the sample size is expected to be around 2000 patients. Frailty will be defined as mFI of 0.27 or higher, with an estimated prevalence of 3% among this patient population. The study will analyze the differences and severity of postoperative complications between frail and non-frail patients, while also examining the trend of frailty over the 15-year period. The expected sample size for the study is around 2000 patients.
Who may be able to join
- The study population consists of patients who underwent minimally invasive distal pancreatectomy for pancreatic body or tail tumors between January 2005 and December 2019.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Postoperative Outcomes of Minimally Invasive Distal Pancreatectomy for Left-sided Pancreatic Tumors Based on the Modified Frailty Index: A Retrospective Cohort Study
This study aims to investigate the difference in postoperative complications according to the modified Frailty Index (mFI) in patients who underwent minimally invasive distal pancreatectomy for pancreatic tumors at the Asan Medical Center's Department of Hepato-Biliary-Pancreatic Surgery from 2005 to 2019. It also seeks to confirm the utility of mFI as a predictive factor for postoperative complications in frail patients in the future.
Read the detailed description
Distal pancreatectomy is a surgery performed to treat tumors in the distal pancreas. The minimally invasive approach to this surgery has become the standard due to its shorter hospital stay, quicker recovery, less pain, and similar complication rates compared to open surgery, especially for benign tumors. In selected patients with malignant tumors, minimally invasive distal pancreatectomy has gradually expanded to a state where it is not inferior to open surgery in terms of postoperative complications and long-term prognosis. As the average lifespan increases, elderly patients with comorbidities are steadily increasing in numbers among those who undergo distal pancreatectomy. However, predicting postoperative complications and mortality rates for these patients is still difficult. Simple yet effective predictive factors for postoperative complications are needed. The Canadian Study of Health and Aging has created a standardized frailty index (CSHA-FI) as a tool for predicting frailty in elderly patients, and a modified Frailty Index (mFI) has been developed for easy use. The mFI has been reported as a predictor of postoperative morbidity and mortality rates after colorectal and vascular surgery. This study aims to investigate whether mFI can be used as a predictive factor for postoperative morbidity and mortality rates in patients who undergo minimally invasive distal pancreatectomy and to utilize it for clinical treatment in the future.
- Conditions
- Postoperative Complication
- Being tested
- Modified frailty index
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified frailty indexBehavioural
The mFI includes the following 11 items from the National Surgical Quality Improvement Program (NSQIP): diabetes; functional status (not independent); chronic obstructive pulmonary disease (COPD) or pneumonia; congestive heart failure; history of myocardial infarction; hypertension requiring medication; peripheral vascular disease or rest pain; impaired sensorium; history of either transient ischemic attack or cerebrovascular accident; history of cerebrovascular accident with neurologic deficit; and prior percutaneous coronary intervention, previous coronary surgery, or history of angina.
| Study group | Role | What they receive |
|---|---|---|
| frail | The mFi categorizes patients with a score of 0.27 or higher as frail and those with a score below that as the non-frail group. Receives: Behavioral: Modified frailty index | |
| and non-frail | The mFi categorizes patients with a score of 0.27 or higher as frail and those with a score below that as the non-frail group. Receives: Behavioral: Modified frailty index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative outcomes
Comparison of the Postoperative outcomes according to the mFI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Jan 2023
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationStudies of the same condition, open and under way.
- 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 participants (actual)
Sponsor and investigators
- Lead sponsor
- Song Cheol Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-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
- NCT05837793
- Sponsor's protocol ID
- 2022-1709
- Status last verified
- Apr 2023
- First submitted
- 19 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park Y, Hwang DW, Lee JH, Song KB, Jun E, Lee W, Kwak BJ, Kim SC. Evaluation of postoperative outcomes of minimally invasive distal pancreatectomy for left-sided pancreatic tumors based on the modified frailty index: a retrospective cohort study. Int J Surg. 2023 Nov 1;109(11):3497-3505. doi: 10.1097/JS9.0000000000000670.
PubMed 37598358
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Outcomes of Minimally Invasive Distal Pancreatectomy for Left-sided Pancreatic Tumors Based on the Modified Frailty Index: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05837793
- Acronym / sponsor ID
- 2022-1709
- Conditions
- Postoperative Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Song Cheol KimUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 1 May 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.
This study aims to investigate the difference in postoperative complications according to the modified Frailty Index (mFI) in patients who underwent minimally invasive distal pancreatectomy for pancreatic tumors at the Asan Medical Center's Department of Hepato-Biliary-Pancreatic Surgery from 2005 to 2019. It also seeks to confirm the utility of mFI as a predictive factor for postoperative complications in frail patients in the future.
Detailed description
Distal pancreatectomy is a surgery performed to treat tumors in the distal pancreas. The minimally invasive approach to this surgery has become the standard due to its shorter hospital stay, quicker recovery, less pain, and similar complication rates compared to open surgery, especially for benign tumors. In selected patients with malignant tumors, minimally invasive distal pancreatectomy has gradually expanded to a state where it is not inferior to open surgery in terms of postoperative complications and long-term prognosis. As the average lifespan increases, elderly patients with comorbidities are steadily increasing in numbers among those who undergo distal pancreatectomy. However, predicting postoperative complications and mortality rates for these patients is still difficult. Simple yet effective predictive factors for postoperative complications are needed. The Canadian Study of Health and Aging has created a standardized frailty index (CSHA-FI) as a tool for predicting frailty in elderly patients, and a modified Frailty Index (mFI) has been developed for easy use. The mFI has been reported as a predictor of postoperative morbidity and mortality rates after colorectal and vascular surgery. This study aims to investigate whether mFI can be used as a predictive factor for postoperative morbidity and mortality rates in patients who undergo minimally invasive distal pancreatectomy and to utilize it for clinical treatment in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| frail | – | Behavioral: Modified frailty indexThe mFi categorizes patients with a score of 0.27 or higher as frail and those with a score below that as the non-frail group. |
| and non-frail | – | Behavioral: Modified frailty indexThe mFi categorizes patients with a score of 0.27 or higher as frail and those with a score below that as the non-frail group. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study aims to investigate the trend of frailty among patients who underwent minimally invasive pancreaticoduodenectomy for pancreatic head tumors between January 2005 and December 2019, using data collected until October 31, 2022. Based on an estimated 150 surgeries per year, the sample size is expected to be around 2000 patients. Frailty will be defined as mFI of 0.27 or higher, with an estimated prevalence of 3% among this patient population. The study will analyze the differences and severity of postoperative complications between frail and non-frail patients, while also examining the trend of frailty over the 15-year period. The expected sample size for the study is around 2000 patients.
Key inclusion criteria (1 listed)
- The study population consists of patients who underwent minimally invasive distal pancreatectomy for pancreatic body or tail tumors between January 2005 and December 2019.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified frailty indexThe mFI includes the following 11 items from the National Surgical Quality Improvement Program (NSQIP): diabetes; functional status (not independent); chronic obstructive pulmonary disease (COPD) or pneumonia; congestive heart failure; history of myocardial infarction; hypertension requiring medication; peripheral vascular disease or rest pain; impaired sensorium; history of either transient ischemic attack or cerebrovascular accident; history of cerebrovascular accident with neurologic deficit; and prior percutaneous coronary intervention, previous coronary surgery, or history of angina. | Behavioural | and non-frail, frail |
Primary outcome
Postoperative outcomes
Time frame: 6 months
Comparison of the Postoperative outcomes according to the mFI
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 1 May 2023.
- Derived from this study: PubMed 37598358Park Y, Hwang DW, Lee JH, Song KB, Jun E, Lee W, Kwak BJ, Kim SC. Evaluation of postoperative outcomes of minimally invasive distal pancreatectomy for left-sided pancreatic tumors based on the modified frailty index: a retrospective cohort study. Int J Surg. 2023 Nov 1;109(11):3497-3505. doi: 10.1097/JS9.0000000000000670.
- 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 Postoperative Complication, run by Song Cheol Kim 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 1 May 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?
Postoperative outcomes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05837793, which also lists 1 linked publication.
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 1 May 2023.