Effects of Surgical Timing on Perioperative Clinical Outcomes in Pancreaticoduodenectomy

NCT ID: NCT06874660

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2025-02-20

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.

Conditions

Pancreaticoduodenal; Fistula; Surgery Timing; Perioperative Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

surgery before 12.00 pm

No interventions assigned to this group

2

surgery before 12.00 pm

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xinrui Zhu，MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xinrui Zhu

Changzhou, Jiangsu, China

Countries

China

Other Identifiers

2025-001

Identifier Type: -

Identifier Source: org_study_id