The Influence of Splenic Artery Characteristics in Gastric Cancer Surgery

NCT06680362 | Active Not Recruiting

• 1 other identifier: KY20242177-C-1
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrectomy; Gastric Carcinoma

Keywords

Gastric carcinoma; Hilus lienis; Vascular anatomy; Ethnicity

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Disease-free survival

  1,3,5 years

Secondary Outcomes (5)

• The relative position of the splenic artery along the pancreas

  Perioperative period

• Classification of splenic artery branches

  Perioperative period

• Overall survival

  1,3,5 years

• The distance between the terminal branch of the splenic artery and the splenic portal

  Perioperative period

• Postoperative complication rate

  30 days

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A patient undergoing laparoscopic radical total gastrectomy in the Department of Gastroenterology, Xijing Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• xiaohua li: lead

Study Sites (1)

The First Affiliated Hospital of PLA Air Force Medical University

Xi'an, Shaanxi, 710032, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

As the study is observational, no specific samples should be collected. It is only necessary to collect the anatomic characteristics and perioperative data of the splenic artery in the included population

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Xiaohua Li

  Department of Gastrointestinal Surgery, Xijing Hospital, Fourth Military Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 8, 2024
• Study Start: May 22, 2022
• Primary Completion: June 30, 2023
• Study Completion: October 31, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• Access Criteria: After collecting and sorting out the data, share it through the form of article publication or email

Locations

CN (1)