Skip to content

Gastrointestinal Surgery Study Group 2001

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04636099
Acronym
GISSG2001
Enrollment
382
Registered
2020-11-19
Start date
2020-11-01
Completion date
2023-11-30
Last updated
2020-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Outcome, Computed Tomography Angiography, Gastrostomy

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.

Interventions

DEVICECT angiography(CTA)

The CTA group was peformed upper abdomen enhenced and CT Angiography before surgery

Sponsors

Qilu Hospital of Shandong University
CollaboratorOTHER
Shandong Provincial Hospital
CollaboratorOTHER_GOV
Qianfoshan Hospital
CollaboratorOTHER
Yantai Yuhuangding Hospital
CollaboratorOTHER
Weifang Medical University
CollaboratorOTHER
Weifang People's Hospital
CollaboratorOTHER
Jining First People's Hospital
CollaboratorOTHER
Weihai Municipal Hospital
CollaboratorOTHER
Weihai Central Hospital
CollaboratorOTHER
Dongying People's Hospital
CollaboratorOTHER
Rizhao People's Hospital
CollaboratorOTHER
People's Hospital of Jimo District, Qingdao
CollaboratorUNKNOWN
Liaocheng People's Hospital
CollaboratorOTHER
The Affiliated Hospital of Qingdao University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative blood lossduring the surgeryhaemorrhagia amount during the operation

Secondary

MeasureTime frameDescription
The total incidence of postoperative complications30 daysthe postoperative complications was defined as the complications related to the surgery or systematic,such as pneumonia,urinary tract infection
Postoperative recovery course30 daysTime to first ambulation, flatus, liquid diet and so on
30-day mortality30 daysthe 30-day mortality was defined as the death occurs related to the surgery or other occasions within 30 days
Number of lymph node dissection guided by vesselduring the surgerythe harvest of lymph node during the gastronomy
3 years OS3 years3 years overall survival after surgery
3 years DFS3 years3 years disease free survival after surgery
hospitalization costs length of hospitalization daysduring the hospitalizationthe total cost of hospitalization related to any therapy

Countries

China

Contacts

Primary ContactZhou Yanbing, MD
zhouyanbing999@aliyun.com86532-82911324
Backup ContactMeng Cheng, MD
pandamch@gmail.com86532-82911324

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026