GastrostomyGISSG2001NCT04636099
Gastrointestinal Surgery Study Group 2001
A study testing CT angiography（CTA） in people with Gastrostomy and Computed Tomography Angiography, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrostomy, Computed Tomography Angiography, Clinical Outcome
- What is being tested?
- CT angiography（CTA）
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- Those who have received neoadjuvant therapy before surgery;
- Pregnant patients;
- Patients who are participating in other clinical studies trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
Qingdao, Shandong, 266000
Zhou Yanbing, 86532-82911324, zhouyanbing999@aliyun.com
About this study
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
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.
- Being tested
- CT angiography（CTA）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT angiography（CTA）Device
The CTA group was peformed upper abdomen enhenced and CT Angiography before surgery
| Study group | Role | What they receive |
|---|---|---|
| CTA Group | Experimental | The CTA group was peformed upper abdomen enhenced and CT Angiography before surgery Receives: Device: CT angiography（CTA） |
| Non-CTA Group | No intervention | The CTA group was routinely peformed upper abdomen enhenced without CT Angiography before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
haemorrhagia amount during the operation
Measured: during the surgery
Secondary outcomes (7)
Number of lymph node dissection guided by vessel
the harvest of lymph node during the gastronomy
Measured: during the surgery
The total incidence of postoperative complications
the postoperative complications was defined as the complications related to the surgery or systematic,such as pneumonia,urinary tract infection
Measured: 30 days
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and so on
Measured: 30 days
30-day mortality
the 30-day mortality was defined as the death occurs related to the surgery or other occasions within 30 days
Measured: 30 days
hospitalization costs length of hospitalization days
the total cost of hospitalization related to any therapy
Measured: during the hospitalization
3 years OS
3 years overall survival after surgery
Measured: 3 years
3 years DFS
3 years disease free survival after surgery
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Nov 2020
- Primary completionNov 2021 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GastrostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Shandong Provincial Hospital, Qianfoshan Hospital, Yantai Yuhuangding Hospital, Weifang Medical University, Weifang People's Hospital, Jining First 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
- Responsible party
- Sponsor
- Investigators
- Zhou Yanbing, MD, Study director, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636099
- Sponsor's protocol ID
- QYFYKYLL791311920
- Acronym
- GISSG2001
- Status last verified
- Dec 2020
- First submitted
- 15 Nov 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 39786664Meng 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.
PubMed 34895320
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04636099
- Acronym / sponsor ID
- GISSG2001 / QYFYKYLL791311920
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Shandong Provincial Hospital, Qianfoshan Hospital, Yantai Yuhuangding Hospital, Weifang Medical University, Weifang People's Hospital, Jining First 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
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTA Group | Experimental | Device: CT angiography（CTA）The CTA group was peformed upper abdomen enhenced and CT Angiography before surgery |
| Non-CTA Group | No intervention | –The CTA group was routinely peformed upper abdomen enhenced without CT Angiography before surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT angiography（CTA）The CTA group was peformed upper abdomen enhenced and CT Angiography before surgery | Device | CTA Group |
Primary outcome
Intraoperative blood loss
Time frame: during the surgery
haemorrhagia amount during the operation
7 secondary outcomes
Number of lymph node dissection guided by vessel
Time frame: during the surgery
The total incidence of postoperative complications
Time frame: 30 days
Postoperative recovery course
Time frame: 30 days
30-day mortality
Time frame: 30 days
hospitalization costs length of hospitalization days
Time frame: during the hospitalization
3 years OS
Time frame: 3 years
3 years DFS
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Derived from this study: PubMed 39786664Meng 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.
- Derived from this study: PubMed 34895320Meng 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhou Yanbing, MD study director
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT angiography（CTA） in people with Gastrostomy and Computed Tomography Angiography, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhou Yanbing, MD (86532-82911324, zhouyanbing999@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: during the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04636099, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.