- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06680362
The Influence of Splenic Artery Characteristics in Gastric Cancer Surgery
Anatomical Characteristics of the Splenic Artery in Northwest China and Its Impact on Laparoscopic Radical Total Gastrectomy
Study Overview
Status
Conditions
Detailed Description
Gastric carcinoma (GC) is the fifth most common malignancy and the fourth most common cause of cancer death worldwide, which has severely affected human health. Although a variety of combined treatment methods, such as chemotherapy and immunotherapy, have improved the treatment effect in recent years, surgery is still the only curative option. The latest CSCO guidelines recommend that splenic hilar lymph nodes must be dissected during total gastrectomy combined with D2 lymph node dissection for advanced gastric cancer. However, as a result of the deep position of the splenic hilum, complicated and variant vessels and covered with fascial tissue, it is difficult to dissect the lymph nodes in the upper pancreatic and splenic hilum regions, which increases the risk of surgery and the difficulty of prognosis recovery. Therefore, a more complete classification and summary of the characteristics of splenic artery will assure the evaluation and implementation of radical gastrectomy.
Currently, a wide variety of classification criteria apply to splenic arteries. One study reported that the splenic artery can be divided into superficial, middle and concealed, based on its location relative to the pancreas. Splenic artery trajectories can also be classified as straight, sinusoidal, serpentine, or alternating. Particularly, it is widely accepted that Zheng et al.'s anatomical classification and clinical implications of the splenic artery are more in-depth and comprehensive. The splenic artery was classified according to the number of branches of its secondary vessels, its position relative to the pancreas, and the distance of the terminal end of the main trunk from the splenic hilum. The results of this study, which focused mainly on the southeastern population, revealed differences in the impact of splenic artery classification on surgery. However, due to different races and the anatomical structure, the classification of the splenic artery differed, which in turn affects the operation and prognosis. In contrast to the study of Zheng et al., which focused primarily on a population in Southeast China, the differences in the anatomical characteristics of the splenic artery in the population in Northwest China may have different effects on the development and prognosis of laparoscopic radical total gastrectomy.
Therefore, we conducted this study to analyze and summarize the characteristics of splenic artery classification and its impact on laparoscopic radical total gastrectomy in the northwest Chinese population.
Inpatients who underwent laparoscopic radical total gastrectomy at the Department of Gastrointestinal Surgery of the First Affiliated Hospital of Air Force Medical University were enrolled. All patients were recruited from five provinces in Northwest China, including Shaanxi Province, Gansu Province, Qinghai Province, the Ningxia Hui Autonomous Region, and the Xinjiang Uygur Autonomous Region. Preoperative endoscopic biopsy confirmed the presence of middle-third or upper third-gastric adenocarcinoma in all study populations treated with surgery. All enrolled patients underwent three-dimensional reconstruction CT scans and other conventional imaging examinations. No patients included in this study had preoperative T4b gastric cancer. Informed consent was obtained from the patients after the study was approved by the ethics committee of the First Affiliated Hospital of Air Force Medical University The distance was also measured in patients who underwent surgery through intraoperative anatomical forceps (fully opened to 2 cm) for comparison with the data measured by three-dimensional imaging. The results were primarily based on the surgical measurements and observations. The patients were divided into concentrated or distributed groups according to the distance. TNM staging was conducted via the eighth version of the AJCC/UICC staging system. In accordance with the Clavien-Dindo classification, an assessment of postoperative complications was conducted. Patients were followed up regularly to compare their survival outcomes.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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陕西
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Xi'an, 陕西, China, 710032
- The First Affiliated Hospital of PLA Air Force Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
① The native place is in Shaanxi Province, Gansu Province, Qinghai Province, Ningxia Hui Autonomous Region, Xinjiang Uygur Autonomous Region;
- The criteria for patients undergoing laparoscopic radical total gastrectomy include: primary adenocarcinoma of the stomach in the upper third or middle third confirmed by histology; Patients with preoperative diagnosis of clinical T2-T4a (cT2-T4a) gastric cancer were free of tumor invasion of neighboring organs (pancreas, spleen, liver, and transverse colon), paraaortic or splenic hilar lymph node enlargement or fusion, and distant metastases as shown by preoperative abdominal computed tomography (CT), abdominal ultrasound, and endoscopic ultrasound; According to the postoperative pathological diagnosis, total gastrectomy, D2 lymph node resection and radical R0 resection were performed.
Exclusion Criteria:
① Patients who did not fully expose the anatomic characteristics of splenic hilar vessels or had evidence of peritoneal spread or distant metastasis during laparoscopic radical gastrectomy;
- Patients with incomplete clinical data;
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Concentrated group
If the distance between the bifurcation of the splenic artery and the splenic hilum was less than 2 cm, the patient was assigned to the concentrated group
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distributed group
If the distance between the splenic artery bifurcation and the splenic portal is greater than or equal to 2cm, it is classified as distributed group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Disease-free survival
Time Frame: 1,3,5 years
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Disease-free survival
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1,3,5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The relative position of the splenic artery along the pancreas
Time Frame: Perioperative period
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If the main trunk of the splenic artery runs entirely on the upper surface of the pancreas, it is classified as type I.
The type II artery was the middle half of the main splenic artery running inside or behind the pancreas.
Similarly, when the distal half of the main splenic artery runs inside or behind the pancreas, it is type III.
In addition, if the distal three-quarters or more of the trunk was completely within the pancreas or lay posterior to the pancreas, it was classified as type IV.
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Perioperative period
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Classification of splenic artery branches
Time Frame: Perioperative period
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The splenic artery without branches was categorized as a single-branch type.
If two splenic lobe arteries emanate from the terminal, they are defined as two-branch types.
Similarly, if the terminal branch has three splenic lobe arteries, it is defined as a 3-branched type; in addition, if there were four or more splenic lobe arteries, it belonged to the multi-branch type.
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Perioperative period
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Overall survival
Time Frame: 1,3,5 years
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Overall survival
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1,3,5 years
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The distance between the terminal branch of the splenic artery and the splenic portal
Time Frame: Perioperative period
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If the distance between the bifurcation of the splenic artery and the splenic hilum was less than 2 cm, the patient was assigned to the concentrated group; otherwise, the patient was assigned to the distributed group.
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Perioperative period
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Postoperative complication rate
Time Frame: 30 days
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Postoperative complication rate refers to the frequency or proportion of patients who experience complications following a surgical procedure.
This metric is typically calculated over a defined postoperative period, such as within 30 days after surgery.
It is an important indicator of surgical safety and the quality of postoperative care.
Postoperative complications can vary widely and may include infections, bleeding, organ dysfunction, and other adverse events that affect the patient's recovery and well-being.
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30 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Xiaohua Li, Department of Gastrointestinal Surgery, Xijing Hospital, Fourth Military Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20242177-C-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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