Effects of Surgical Timing on Perioperative Clinical Outcomes in Pancreaticoduodenectomy

Completed

• Conditions: Pancreaticoduodenal; Fistula; Surgery Timing; Perioperative Complication

• Registration Number: NCT06874660
• Lead Sponsor: West China Hospital

Brief Summary

With the advancement of surgical techniques and the increase in pancreatic oncologic diseases, the volume of pancreaticoduodenal surgeries has been increasing year by year in our center, and multiple pancreaticoduodenal surgeries are often performed on the day of surgery. This study will compare the effect of pancreaticoduodenal surgery performed at different times on patient prognosis. This study plans to divide the patients into morning group, afternoon group, and night group through the start time of surgery, and this study plans to analyze subgroups such as laparoscopic pancreaticoduodenal surgery. The outcome indicators include perioperative complications such as pancreatic fistula, bleeding, abdominal infection, hospitalization cost, and length of hospital stay. The conclusions drawn from this study will suggest to surgeons whether pancreaticoduodenal surgery performed at different times of the day will have different outcomes for patients and will guide surgeons on the timing of pancreaticoduodenal surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-20
• Status Verified: 2025-03
• Study First Submitted: 2025-03-09
• Study First Submitted QC: 2025-03-09
• Last Update Submitted: 2025-03-09
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Patients must be required to sign an informed consent form;
2. Age 18-80 years, male and female;
3. ECOG Physical Status Score (PS Score) 0 or 1.
4. Pancreaticoduodenectomy at our center without contraindications related to the surgery.

Exclusion Criteria

1. Pre-existing or concurrent other malignant tumors
2. Severe cardiopulmonary and renal dysfunction.
3. Autoimmune disease or history of immunodeficiency
4. Active infections and infectious diseases requiring systemic therapy.
5. History of psychotropic substance abuse, alcoholism or drug addiction.
6. Failure to meet the inclusion criteria as determined by the investigator.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
perioperative complication	perioperative	pancreatic fistula; postoperative bleeding; abdominal infection; delayed gastric emptying

Secondary Outcome Measures

Name	Time	Method
Length of hospitalization	perioperative	Length of admission to surgery; length of surgery; length of postoperative stay to discharge

Trial Locations

Locations (1)

Xinrui Zhu; 🇨🇳 Changzhou, Jiangsu, China