Gastrointestinal Surgery Study Group 2001

Gastrostomy Clinical Trial

— GISSG2001  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04636099
• Other study ID #: QYFYKYLL791311920
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: November 2023

Study information

• Verified date: December 2020
• Source: The Affiliated Hospital of Qingdao University
• Contact: Zhou Yanbing, MD
• Phone: 86532-82911324
• Email: zhouyanbing999[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 382
• Est. completion date: November 2023
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Pathological diagnosis of gastric adenocarcinoma by gastroscopy

2. Age 18~75 years old

3. BMI=25.0kg/m2

4. Preoperative imaging staging is T1~T4a, N0~3, M0

5. The surgical approach is laparoscopic surgery and robotic surgery

Exclusion Criteria:

1. 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;

2. suffering from other malignant tumors, tumors of low malignant potential (giant cell tumor of bone, pseudomyxadenoma of appendix, invasive fibroma) in the past;

3. Patients who have serious other system diseases and cannot tolerate surgery;

4. Patients with non-adenocarcinoma type malignant tumors in pathology after surgery;

5. Patients with residual gastric cancer;

6. Those who are allergic to iodine contrast agents;

7. Those who have received neoadjuvant therapy before surgery;

8. Pregnant patients;

9. Patients who are participating in other clinical studies trial.

Related Conditions & MeSH terms

• Clinical Outcome
• Computed Tomography Angiography
• Gastrostomy

Intervention

Device:
• CT angiography(CTA)
The CTA group was peformed upper abdomen enhenced and CT Angiography before surgery

Locations

Country	Name	City	State
China	Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital	Qingdao	Shandong

Sponsors (14)

Lead Sponsor

Collaborator

The Affiliated Hospital of Qingdao University

Dongying People's Hospital, Liaocheng People's Hospital, People's Hospital of Jimo District, Qingdao, Qilu Hospital of Shandong University, Rizhao People's Hospital, Shandong Jining No.1 People's Hospital, Shandong Province Qianfoshan Hospital, Shandong Provincial Hospital, Weifang Medical University, Weifang People's Hospital, Weihai Central Hospital, Weihai Municipal Hospital, Yantai Yuhuangding Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative blood loss	haemorrhagia amount during the operation	during the surgery
Secondary	Number of lymph node dissection guided by vessel	the harvest of lymph node during the gastronomy	during the surgery
Secondary	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
Secondary	Postoperative recovery course	Time to first ambulation, flatus, liquid diet and so on	30 days
Secondary	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
Secondary	hospitalization costs length of hospitalization days	the total cost of hospitalization related to any therapy	during the hospitalization
Secondary	3 years OS	3 years overall survival after surgery	3 years
Secondary	3 years DFS	3 years disease free survival after surgery	3 years