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.

NCT ID: NCT06763250

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 280 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-12-31

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 "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.

Conditions

Pancreatic Carcinoma; Cholangiocarcinoma; Pancreaticoduodenectomy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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 death during hospitalization or within 30 days after surgery, and no re-admission within 30 days after discharge were integrated as a comprehensive index. It can reflect the ideal surgical outcome. We divided the clinical data into a TO group and a non-TO group through retrospective analysis. In order to promote the standardization and standardization of PD surgical quality assessment.

No interventions assigned to this group

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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• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

luokai zhang

OTHER

Sponsor Role: lead

Responsible Party

luokai zhang

Changzhou Second People's Hospital, Jiangsu Province

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The Second People's Hospital of Changzhou, Jiangsu Province, China

Changzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chunfu zhu, MD

Role: CONTACT

zcfmlm@njmu.edu.cn

13961190702

Facility Contacts

zhunfu zhu, PhD

Role: primary

zcfmlm@njmu.edu.cn

13961190702

References

Ma L, Wu S, Cheng Y, Gao Y, Fan J, Zhu C. Laparoscopic duodenum-preserving total pancreatic head resection for benign and low-grade malignant tumors close to the accessory papilla (a case series). Surg Endosc. 2025 Oct 23. doi: 10.1007/s00464-025-12236-9. Online ahead of print.

Reference Type: DERIVED

PMID: 41128852 (View on PubMed)

Other Identifiers

CN CZEY

Identifier Type: -

Identifier Source: org_study_id