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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

382

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

Study Start

First participant enrolled

November 1, 2020

Completed

14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2020

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed

Last Updated

December 9, 2020

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

November 15, 2020

Last Update Submit

December 6, 2020

Conditions

Gastrostomy Computed Tomography Angiography Clinical Outcome

Outcome Measures

Primary Outcomes (1)

Intraoperative blood loss
haemorrhagia amount during the operation
during the surgery

Secondary Outcomes (7)

Number of lymph node dissection guided by vessel
during the surgery
The total incidence of postoperative complications
30 days
Postoperative recovery course
30 days
30-day mortality
30 days
hospitalization costs length of hospitalization days
during the hospitalization
+2 more secondary outcomes

Study Arms (2)

CTA Group

EXPERIMENTAL

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

Device: CT angiography（CTA）

Non-CTA Group

NO INTERVENTION

The CTA group was routinely peformed upper abdomen enhenced without CT Angiography before surgery

Interventions

CT angiography（CTA）DEVICE

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

CTA Group

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Study Sites (1)

Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital

Qingdao, Shandong, 266000, China

RECRUITING

Related Publications (2)

Meng C, Cao S, Li L, Xia L, Chu X, Jiang L, Wang X, Wang H, Huang S, Duan Q, Sun Z, He Q, Hui X, Yang D, Zhang H, Li Z, Liu X, Tian Y, Sun Y, Li Y, Jiang H, Niu Z, Zhang J, Zhou Y. Short-term outcomes of preoperative computed tomography angiography versus standard assessment in patients with BMI >/= 25.0 kg/m2 undergoing laparoscopic gastrectomy: the GISSG20-01 randomized clinical trial. Gastric Cancer. 2025 Mar;28(2):283-293. doi: 10.1007/s10120-024-01580-9. Epub 2025 Jan 9.
PMID: 39786664DERIVED
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.
PMID: 34895320DERIVED

Study Officials

Zhou Yanbing, MD
The Affiliated Hospital of Qingdao University
STUDY DIRECTOR

Central Study Contacts

Zhou Yanbing, MD

CONTACT

86532-82911324 zhouyanbing999@aliyun.com

Meng Cheng, MD

CONTACT

86532-82911324 pandamch@gmail.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 15, 2020

First Posted

November 19, 2020

Study Start

November 1, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2023

Last Updated

December 9, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN(1)

Gastrointestinal Surgery Study Group 2001

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

CTA Group

Non-CTA Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

CTA Group

Non-CTA Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations