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Gastrointestinal Surgery Study Group 2001 (GISSG2001)

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ClinicalTrials.gov Identifier: NCT04636099
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : December 9, 2020
Sponsor:
Collaborators:
Qilu Hospital of Shandong University
Shandong Provincial Hospital
Shandong Province Qianfoshan Hospital
Yantai Yuhuangding Hospital
Weifang Medical University
Weifang People's Hospital
Shandong Jining No.1 People's Hospital
Weihai Municipal Hospital
Weihai Central Hospital
Dongying People's Hospital
Rizhao People's Hospital
People's Hospital of Jimo District, Qingdao
Liaocheng People's Hospital
Information provided by (Responsible Party):
The Affiliated Hospital of Qingdao University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Gastrostomy Computed Tomography Angiography Clinical Outcome Device: CT angiography（CTA） Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 382 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CTA Group
The CTA group was peformed upper abdomen enhenced and CT Angiography before surgery
 Device: CT angiography（CTA）
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


Outcome Measures
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Primary Outcome Measures :
  1. Intraoperative blood loss [ Time Frame: during the surgery ]
    haemorrhagia amount during the operation


Secondary Outcome Measures :
  1. Number of lymph node dissection guided by vessel [ Time Frame: during the surgery ]
    the harvest of lymph node during the gastronomy

  2. 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

  3. Postoperative recovery course [ Time Frame: 30 days ]
    Time to first ambulation, flatus, liquid diet and so on

  4. 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

  5. hospitalization costs length of hospitalization days [ Time Frame: during the hospitalization ]
    the total cost of hospitalization related to any therapy

  6. 3 years OS [ Time Frame: 3 years ]
    3 years overall survival after surgery

  7. 3 years DFS [ Time Frame: 3 years ]
    3 years disease free survival after surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04636099


Contacts
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Contact: Zhou Yanbing, MD 86532-82911324 zhouyanbing999@aliyun.com
Contact: Meng Cheng, MD 86532-82911324 pandamch@gmail.com

Locations
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China, Shandong
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital Recruiting
Qingdao, Shandong, China, 266000
Contact: Zhou Yanbing    86532-82911324    zhouyanbing999@aliyun.com   
Sponsors and Collaborators
The Affiliated Hospital of Qingdao University
Qilu Hospital of Shandong University
Shandong Provincial Hospital
Shandong Province Qianfoshan Hospital
Yantai Yuhuangding Hospital
Weifang Medical University
Weifang People's Hospital
Shandong Jining No.1 People's Hospital
Weihai Municipal Hospital
Weihai Central Hospital
Dongying People's Hospital
Rizhao People's Hospital
People's Hospital of Jimo District, Qingdao
Liaocheng People's Hospital
Investigators
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Study Director: Zhou Yanbing, MD The Affiliated Hospital of Qingdao University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The Affiliated Hospital of Qingdao University
ClinicalTrials.gov Identifier: NCT04636099    
Other Study ID Numbers: QYFYKYLL791311920
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No