Clinical trial NCT04636099: Gastrointestinal Surgery Study Group 2001
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrostomy
Computed Tomography Angiography
Clinical Outcome
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
Collaborators: name: Qilu Hospital of Shandong University
name: Shandong Provincial Hospital
name: Qianfoshan Hospital
name: Yantai Yuhuangding Hospital
name: Weifang Medical University
name: Weifang People's Hospital
name: Jining First People's Hospital
name: Weihai Municipal Hospital
name: Weihai Central Hospital
name: Dongying People's Hospital
name: Rizhao People's Hospital
name: People's Hospital of Jimo District, Qingdao
name: Liaocheng People's Hospital
First posted: 2020-11-19
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: during the surgery
Secondary outcomes:
measure: Number of lymph node dissection guided by vessel
timeFrame: during the surgery
measure: The total incidence of postoperative complications
timeFrame: 30 days
measure: Postoperative recovery course
timeFrame: 30 days
measure: 30-day mortality
timeFrame: 30 days
measure: hospitalization costs length of hospitalization days
timeFrame: during the hospitalization
measure: 3 years OS
timeFrame: 3 years
measure: 3 years DFS
timeFrame: 3 years
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Zhou Yanbing, MD
role: STUDY_DIRECTOR
References:
citation: Meng C, Cao S, Liu X, Li L, He Q, Xia L, Jiang L, Chu X, Wang X, Wang H, Hui X, Sun Z, Huang S, Duan Q, Yang D, Zhang H, Tian Y, Li Z, Zhou Y. Effect of preoperative CT angiography examination on the clinical outcome of patients with BMI >/= 25.0 kg/m2 undergoing laparoscopic gastrectomy: study protocol for a multicentre randomized controlled trial. Trials. 2021 Dec 11;22(1):912. doi: 10.1186/s13063-021-05887-1.