Modified Frailty Index for Minimally Invasive Distal Pancreatectomy

NCT05837793 | Completed

• 1 other identifier: 2022-1709
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complication

Outcome Measures

Primary Outcomes (1)

• Postoperative outcomes

  Comparison of the Postoperative outcomes according to the mFI

  6 months

Study Arms (2)

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.

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.

Behavioral: Modified frailty index

Interventions

Modified frailty index BEHAVIORAL

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.

and non-frail; frail

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Song Cheol Kim: lead

Study Sites (1)

Asan medical center

Seoul, Republic of Korea, ks013, South Korea

Location

Related Publications (1)

• 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.

  PMID: 37598358 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Song Cheol Kim, MD. PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: January 1, 2023
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)