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2024-01-01
2024-01-01
2024-12-31
280
NCT06763250
Changzhou No.2 People's Hospital
Changzhou No.2 People's Hospital
OBSERVATIONAL
In This Study, a Retrospective Analysis Was Conducted to Explore the Risk Factors for Patients Undergoing Pancreaticoduodenal Surgery (PD) to Achieve TO, and a Nomogram Prediction Model Was Further Established to Promote the Standardization and Standardization of PD Surgical Quality Evaluation.
This study is committed TO exploring the risk factors affecting patients receiving pancreaticoduodenal surgery (PD) to achieve TO by retrospective analysis of clinical data of patients receiving PD surgery in Changzhou Second People Hospital from January 2016 to December 2024, and further establishing a nomogram prediction model. In order to promote the standardization and standardization of PD surgical quality assessment.
As we all know, pancreaticoduodenectomy (whipple) involving multiple organ reconstruction for pancreatic cancer is known as the "surgical ceiling", but because of its high postoperative complication rate and poor prognosis, a standardized surgical quality assessment system covering the whole perioperative period is urgently needed. The concept of the textbook ending was born.it first appeared in a 2013 study by Kolfschoten et al for colorectal cancer, in which textbook outcomes were evaluated in an all or none ,manner against six independent expected outcome measures: There were no deaths in hospital or within 30 days after surgery, radical resection, no re-intervention, no stomy, no serious postoperative complications, and no prolonged hospital stay. That is, when patients meet the above six indicators at the same time, they are defined as achieving a textbook outcome .In our study, the textbook outcome is the primary outcome, and the reverse is the secondary outcome.This study is committed TO exploring the risk factors affecting patients receiving pancreaticoduodenal surgery (PD) to achieve TO by retrospective analysis of clinical data of patients receiving PD surgery in Changzhou Second People Hospital from January 2016 to December 2024, and further establishing a nomogram prediction model. In order to promote the standardization and standardization of PD surgical quality assessment.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-01-02 | N/A | 2025-01-02 |
2025-01-02 | N/A | 2025-01-08 |
2025-01-08 | N/A | 2024-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : We divided the clinical data into a TO group and a non-TO group through retrospective analysis A textbook outcome (TO) of pancreatic surgery based on an international expert consensus, No postoperative hemorrhage of grade B/C, no postoperative pancreatic fistula of grade B/C, no biliary leakage of grade B/C, Clavien-Dindo complication grade < Ⅲ, no |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Achieve TO as the main ending | We expected TO collect 280 PD surgery patients, 262 cases have been collected, of which 158 cases achieved TO as the main outcome, the TO rate is 60.31%. | from January 2016 to August 2024 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Chunfu zhu, MD Phone Number: 13961190702 Email: zcfmlm@njmu.edu.cn |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
40 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
