Gastrointestinal Surgery Study Group 2001 (GISSG2001)

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

382

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Shandong
      • Qingdao, Shandong, China, 266000
        • Recruiting
        • Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CTA Group
The CTA group was peformed upper abdomen enhenced and CT Angiography before surgery
The CTA group was peformed upper abdomen enhenced and CT Angiography before surgery
No Intervention: Non-CTA Group
The CTA group was routinely peformed upper abdomen enhenced without CT Angiography before surgery

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

November 15, 2020

First Submitted That Met QC Criteria

November 15, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

December 9, 2020

Last Update Submitted That Met QC Criteria

December 6, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • QYFYKYLL791311920

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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