Effects of Surgical Timing on Perioperative Clinical Outcomes in Pancreaticoduodenectomy

NCT06874660 | Completed

• 1 other identifier: 2025-001
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• perioperative complication

  pancreatic fistula; postoperative bleeding; abdominal infection; delayed gastric emptying

  perioperative

Secondary Outcomes (1)

• Length of hospitalization

  perioperative

Other Outcomes (1)

• Cost of hospitalization

  perioperative

Study Arms (2)

1

surgery before 12.00 pm

2

surgery before 12.00 pm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who met the surgical guidelines for pancreaticoduodenectomy and underwent pancreaticoduodenectomy during the trial period

You may qualify if:

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

You may not qualify if:

• Pre-existing or concurrent other malignant tumors
• Severe cardiopulmonary and renal dysfunction.
• Autoimmune disease or history of immunodeficiency
• Active infections and infectious diseases requiring systemic therapy.
• History of psychotropic substance abuse, alcoholism or drug addiction.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Xinrui Zhu

Changzhou, Jiangsu, 213000, China

Location

MeSH Terms

Conditions

Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 13, 2025
• Study Start: January 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: February 20, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

CN (1)