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.

NCT06763250 | Unknown DMC

• 1 other identifier: CN CZEY
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Carcinoma; Cholangiocarcinoma; Pancreaticoduodenectomy

Keywords

textbook outcome; pancreatic carcinoma; cholangiocarcinoma; pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• luokai zhang: lead

Study Sites (1)

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

Changzhou, Jiangsu, 213000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 41128852 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Chunfu zhu, MD

CONTACT

13961190702; zcfmlm@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Changzhou Second People's Hospital, Jiangsu Province

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: January 1, 2024
• Primary Completion: January 1, 2024
• Study Completion: December 31, 2024
• Last Updated: January 8, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)