Modified Frailty Index for Minimally Invasive Distal Pancreatectomy

Completed

• Conditions: Postoperative Complication
• Interventions: Behavioral: Modified frailty index

• Registration Number: NCT05837793
• Lead Sponsor: Song Cheol Kim

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.

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-04
• Primary Completion: 2023-04-10
• Study Completion: 2023-04-10
• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-04-19
• Last Update Submitted: 2023-04-19
• Study First Posted: 2023-05-01
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
and non-frail	Modified frailty index	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.
frail	Modified frailty index	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.

Primary Outcome Measures

Name	Time	Method
Postoperative outcomes	6 months	Comparison of the Postoperative outcomes according to the mFI

Trial Locations

Locations (1)

Asan medical center; 🇰🇷 Seoul, Republic Of Korea, Korea, Republic of