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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06405009
Other study ID # NorthernJiangsu003
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 22, 2024
Est. completion date June 30, 2024

Study information

Verified date May 2024
Source Northern Jiangsu People's Hospital
Contact Yifan Cheng
Phone 8615267258283
Email cyfchengyifan528@sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A complete omentectomy is typically recommended during radical total gastrectomy for gastric cancer, though its impact on survival remains unclear. This study aimed to assess the frequency and risk factors of metastases in the greater omentum in gastric cancer patients undergoing gastrectomy. It will involve a single prospective cohort of consecutive patients who underwent total gastrectomy with complete en bloc omentectomy and modified D2 lymphadenectomy. Post-surgery, the omentum will dissect from the gastrectomy specimen beyond the gastroepiploic vessels and examine separately for pathological assessment. The primary outcome will focus on the detection of omental metastases.


Recruitment information / eligibility

Status Recruiting
Enrollment 450
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. pathological confirmation of gastric cancer 2. eligibility for surgical intervention 3. undergoing first rectal cancer surgery 4. acquisition of written informed consent from patients and their families 5. no history of hypertrophic scar or allergic predispositions Exclusion Criteria: 1. absence of postoperative pathology of the omentum 2. diagnosis of multiple primary malignancies 3. intraoperative discovery of widespread implant metastases within the abdominal cavity 4. severe comorbidities

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Without any intervention, we only divided gastric cancer patients into two groups based on postoperative pathology, and analyzed their basic characteristics and risk factors
Without any intervention, we only divided gastric cancer patients into two groups based on postoperative pathology, and analyzed their basic characteristics and risk factors

Locations

Country Name City State
China Yifan Cheng Yangzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Northern Jiangsu People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary patients with omental metastases After the operation, the postoperative pathological examination of the patient indicated the presence of omental metastases up to 2 weeks after gastric cancer surgery
Primary patients without omental metastases After surgery, pathological examination confirmed no omental metastases up to 2 weeks after gastric cancer surgery
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