NCT05975710

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,552

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

2.8 years

First QC Date

July 15, 2023

Last Update Submit

August 2, 2023

Conditions

Surgery-Complications

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • The patients who underwent MIPD between May 2007 and April 2020 at ten tertiary referral institutions in South Korea.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan medical center

Seoul, 05505, South Korea

Location

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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 15, 2023

First Posted

August 4, 2023

Study Start

April 1, 2020

Primary Completion

December 31, 2022

Study Completion

March 1, 2023

Last Updated

August 4, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)