Clinical trial NCT06763250: 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.
Official title: Risk Factors Influencing Textbook Outcomes in PD Surgery-a Single-center Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Carcinoma
Cholangiocarcinoma
Pancreaticoduodenectomy
Keywords: textbook outcome
pancreatic carcinoma
cholangiocarcinoma
pancreaticoduodenectomy
Lead sponsor: Changzhou No.2 People's Hospital
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 280
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From the 260 specimens collected so far in this study, we obtained the description of the study population. In terms of age, 6.53% of the samples were less than 50 years old, 13.84% were more than or equal to 50 years old and 60 years old, 46.54% were more than or equal to 60 years old and 70 years old, 29.23% were more than or equal to 70 years old and 3.86% were more than or equal to 80 years old. In terms of gender, 57.31% of the sample were male and 42.69% were female. All the samples in this study were Han. 98.85% of the sample were married. The population samples for this study were all from the Second People\&#39;s Hospital of Changzhou City.The risk factors affecting the textbook outcome of PD surgery in this study population were: 1. Diabetes; 2. Preoperative bile duct inflammation; 3. Intraoperative pancreatic duct diameter; 4; Vascular invasion; 5. Duration of operation; 6. Surgical method.

Brief summary: 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.

Detailed description: As we all know, pancreaticoduodenectomy (whipple) involving multiple organ reconstruction for pancreatic cancer is known as the \&#34;surgical ceiling\&#34;, 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.

Eligibility criteria: Inclusion Criteria:

1. Patients who received radical PD surgery and whose pathological findings were clear tumors;
2. Complete clinical data preservation.

Exclusion Criteria:

1. Palliative resection; 2. Tumor metastasis or other primary tumors; 3. Combined with severe organ dysfunction; 4. Postoperative pathology was not clear tumor.

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Primary outcomes:
measure: Achieve TO as the main ending
timeFrame: from January 2016 to August 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Changzhou City
country: China
facility: The Second People's Hospital of Changzhou, Jiangsu Province, China
state: Jiangsu
Study officials:
References: