- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04636099
Gastrointestinal Surgery Study Group 2001 (GISSG2001)
Preoperative CTA to Evaluate the Influence of Gastric Artery Type on the Clinical Outcome of Gastric Cancer Patients With BMI≥25.0 kg/m2:A Multicenter Randomized Controlled Study
Gastric cancer is one of the most common malignace worldwide, which caused a dramatically death rate, especially in east Asian, such as Japan , South Korea and China. Although the treatment of gastric cancer has a large improvement, such as radiotherapy, chemotherapy and immunotherapy, surgery is yet the mainstream method for the curable malignace without distant metastasis. As the innovation of treatment in gastric caner, laprascopic has gain its popularity owing to its equivalent oncologic outcomes, earlier oral feeding, shorten postopertative of hospital length,compared with open surgery. Depite it has several advantages, the defect of laparascopic surgery is still obvious, such as 2D surgical field, lack of inverse haptic feedback, Inflexible equipment.
D2 Lymph node dissection associated with laparascopic gastronomy is still regard as standard surgical procedure for the gastric cancer patient whose tumor stage was evaluated in advance stage. As we known that the distribution of lymph nod is accompanied with blood vessels, even for well-trained surgeon, the procedure lymph node dissection is a challenging and tough work. Computed Tomography Angiography(3D-CTA), as a emerging technology, is gradually receive the surgeon's attention for its remedy characteristic to the defect of laparascopic surgery, which can visually display the distribution and type of perigastric artery, resulting in decresing the difficulty and risk of surgery.
The aim of the study is to investigate the clinincal outcomes for the patient with BMI ≥25 kg/㎡who underwent laparascopic or robotic gastronomy using CTA to evaluate the type of perigastric artery.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zhou Yanbing, MD
- Phone Number: 86532-82911324
- Email: zhouyanbing999@aliyun.com
Study Contact Backup
- Name: Meng Cheng, MD
- Phone Number: 86532-82911324
- Email: pandamch@gmail.com
Study Locations
-
-
Shandong
-
Qingdao, Shandong, China, 266000
- Recruiting
- Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
-
Contact:
- Zhou Yanbing
- Phone Number: 86532-82911324
- Email: zhouyanbing999@aliyun.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pathological diagnosis of gastric adenocarcinoma by gastroscopy
- Age 18~75 years old
- BMI≥25.0kg/m2
- Preoperative imaging staging is T1~T4a, N0~3, M0
- The surgical approach is laparoscopic surgery and robotic surgery
Exclusion Criteria:
- Patients whose tumors stage are found to be T4b or M1 during the operation, tumors are unresectable and accompanied with malignant tumors in other parts;
- suffering from other malignant tumors, tumors of low malignant potential (giant cell tumor of bone, pseudomyxadenoma of appendix, invasive fibroma) in the past;
- Patients who have serious other system diseases and cannot tolerate surgery;
- Patients with non-adenocarcinoma type malignant tumors in pathology after surgery;
- Patients with residual gastric cancer;
- Those who are allergic to iodine contrast agents;
- Those who have received neoadjuvant therapy before surgery;
- Pregnant patients;
- Patients who are participating in other clinical studies trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CTA Group
The CTA group was peformed upper abdomen enhenced and CT Angiography before surgery
|
The CTA group was peformed upper abdomen enhenced and CT Angiography before surgery
|
No Intervention: Non-CTA Group
The CTA group was routinely peformed upper abdomen enhenced without CT Angiography before surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraoperative blood loss
Time Frame: during the surgery
|
haemorrhagia amount during the operation
|
during the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of lymph node dissection guided by vessel
Time Frame: during the surgery
|
the harvest of lymph node during the gastronomy
|
during the surgery
|
The total incidence of postoperative complications
Time Frame: 30 days
|
the postoperative complications was defined as the complications related to the surgery or systematic,such as pneumonia,urinary tract infection
|
30 days
|
Postoperative recovery course
Time Frame: 30 days
|
Time to first ambulation, flatus, liquid diet and so on
|
30 days
|
30-day mortality
Time Frame: 30 days
|
the 30-day mortality was defined as the death occurs related to the surgery or other occasions within 30 days
|
30 days
|
hospitalization costs length of hospitalization days
Time Frame: during the hospitalization
|
the total cost of hospitalization related to any therapy
|
during the hospitalization
|
3 years OS
Time Frame: 3 years
|
3 years overall survival after surgery
|
3 years
|
3 years DFS
Time Frame: 3 years
|
3 years disease free survival after surgery
|
3 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Zhou Yanbing, MD, The Affiliated Hospital of Qingdao University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- QYFYKYLL791311920
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (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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