Gastrointestinal Surgery Study Group 2001

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gastrostomy, Computed Tomography Angiography, Clinical Outcome

Intervention / Treatment
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* Device: CT angiography（CTA）


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTA Group<br>The CTA group was peformed upper abdomen enhenced and CT Angiography before surgery | Device: CT angiography（CTA）<br>* The CTA group was peformed upper abdomen enhenced and CT Angiography before surgery<br>|
| No Intervention: Non-CTA Group<br>The CTA group was routinely peformed upper abdomen enhenced without CT Angiography before surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss | 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 | the harvest of lymph node during the gastronomy | during the surgery | 
| The total incidence of postoperative complications | 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 to first ambulation, flatus, liquid diet and so on | 30 days | 
| 30-day mortality | 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 | the total cost of hospitalization related to any therapy | during the hospitalization | 
| 3 years OS | 3 years overall survival after surgery | 3 years | 
| 3 years DFS | 3 years disease free survival after surgery | 3 years |