Effects of Surgical Timing on Perioperative Clinical Outcomes in Pancreaticoduodenectomy

March 9, 2025 updated by: Xinrui Zhu，MD, West China Hospital

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Changzhou, Jiangsu, China, 213000
        • Xinrui Zhu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
surgery before 12.00 pm
2
surgery before 12.00 pm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
perioperative complication
Time Frame: perioperative
pancreatic fistula; postoperative bleeding; abdominal infection; delayed gastric emptying
perioperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospitalization
Time Frame: perioperative
Length of admission to surgery; length of surgery; length of postoperative stay to discharge
perioperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost of hospitalization
Time Frame: perioperative
Cost of surgery; cost of postoperative medications; total cost of hospitalization
perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

February 20, 2025

Study Registration Dates

First Submitted

March 9, 2025

First Submitted That Met QC Criteria

March 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 9, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-001 (Oblastní nemocnice Kolín a.s.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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