Effects of Surgical Timing on Perioperative Clinical Outcomes in Pancreaticoduodenectomy

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.

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Key information

Conditions

Pancreaticoduodenal; Fistula Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Perioperative Complication Surgery Timing

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xinrui Zhu

Changzhou, Jiangsu, 213000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.
Failure to meet the inclusion criteria as determined by the investigator.

Treatment and study plan

Primary outcomes

perioperative complication

Time frame: perioperative

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

Secondary outcomes

Length of hospitalization

Time frame: perioperative

Length of admission to surgery; length of surgery; length of postoperative stay to discharge

Other outcomes

Cost of hospitalization

Time frame: perioperative

Cost of surgery; cost of postoperative medications; total cost of hospitalization

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Influence of Timing on Outcomes of Pancreaticoduodenectomy: Complications, Hospital Costs, and Length of Stay

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2025
First posted: Mar 13, 2025
Registry last updated: Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed