Clinical trial NCT05837793: Modified Frailty Index for Minimally Invasive Distal Pancreatectomy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complication
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* The study population consists of patients who underwent minimally invasive distal pancreatectomy for pancreatic body or tail tumors between January 2005 and December 2019.

Exclusion Criteria:

* None

Primary outcomes:
measure: Postoperative outcomes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
state: Republic Of Korea
Study officials:
affiliation: Asan Medical Center
name: Song Cheol Kim, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: