GastrectomyNCT06680362
The Influence of Splenic Artery Characteristics in Gastric Cancer Surgery
An observational study of Gastrectomy and Gastric Carcinoma, run by xiaohua li at 1 site in China.
Trial summary
The northwest Chinese population has unique anatomical characteristics of splenic artery due to ethnic differences, which has an important impact on the development and prognosis of laparoscopic radical total gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrectomy, Gastric Carcinoma
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2022to 31 Oct 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A patient undergoing laparoscopic radical total gastrectomy in the Department of Gastroenterology, Xijing Hospital
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of PLA Air Force Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Anatomical Characteristics of the Splenic Artery in Northwest China and Its Impact on Laparoscopic Radical Total Gastrectomy
The northwest Chinese population has unique anatomical characteristics of splenic artery due to ethnic differences, which has an important impact on the development and prognosis of laparoscopic radical total gastrectomy.
Read the 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.
- Conditions
- Gastrectomy, Gastric Carcinoma
- Keywords
- Gastric carcinoma; Hilus lienis; Vascular anatomy; Ethnicity
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Disease-free survival
Measured: 1,3,5 years
Secondary outcomes (5)
The relative position of the splenic artery along the pancreas
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.
Measured: Perioperative period
Classification of splenic artery branches
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.
Measured: Perioperative period
Overall survival
Overall survival
Measured: 1,3,5 years
The distance between the terminal branch of the splenic artery and the splenic portal
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.
Measured: Perioperative period
Postoperative complication rate
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start22 May 2022
- Primary completion30 Jun 2023
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xiaohua li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, xiaohua li, Xijing Hospital of Digestive Diseases
- Investigators
- Xiaohua Li, Study director, Department of Gastrointestinal Surgery, Xijing Hospital, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680362
- Sponsor's protocol ID
- KY20242177-C-1
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After collecting and sorting out the data, share it through the form of article publication or email
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Characteristics of the Splenic Artery in Northwest China and Its Impact on Laparoscopic Radical Total Gastrectomy
- ClinicalTrials.gov ID
- NCT06680362
- Acronym / sponsor ID
- KY20242177-C-1
- Conditions
- Gastrectomy, Gastric Carcinoma
- Keywords
- Gastric carcinoma; Hilus lienis; Vascular anatomy; Ethnicity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- xiaohua liUniversity, hospital or other
- Study start
- 22 May 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The northwest Chinese population has unique anatomical characteristics of splenic artery due to ethnic differences, which has an important impact on the development and prognosis of laparoscopic radical total gastrectomy.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A patient undergoing laparoscopic radical total gastrectomy in the Department of Gastroenterology, Xijing Hospital
Key inclusion criteria (2 listed)
- ① The native place is in Shaanxi Province, Gansu Province, Qinghai Province, Ningxia Hui Autonomous Region, Xinjiang Uygur Autonomous Region;
Key exclusion criteria (2 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease-free survival
Time frame: 1,3,5 years
Disease-free survival
5 secondary outcomes
The relative position of the splenic artery along the pancreas
Time frame: Perioperative period
Classification of splenic artery branches
Time frame: Perioperative period
Overall survival
Time frame: 1,3,5 years
The distance between the terminal branch of the splenic artery and the splenic portal
Time frame: Perioperative period
Postoperative complication rate
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: Yes. After collecting and sorting out the data, share it through the form of article publication or email
Related trials for Gastrectomy
RecruitingObservational study
Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity
Obesity & Overweight
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Recruiting
Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy
Gastric Cancer, Postoperative Delirium
Not yet recruitingPhase 2
D2 Gastrectomy With or Without Para-Aortic Lymph Node Dissection After Chemoimmunotherapy for Gastric Cancer
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Recruiting
TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)
Gastric Cancer (GC), Stomach Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaohua Li study director
Department of Gastrointestinal Surgery, Xijing Hospital, Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrectomy and Gastric Carcinoma, run by xiaohua li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 1,3,5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.