Gastrointestinal Surgery Study Group 2001

NCT ID: NCT04636099

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

382 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2023-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrostomy Computed Tomography Angiography Clinical Outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CTA Group

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

Group Type EXPERIMENTAL

CT angiography(CTA)

Intervention Type DEVICE

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

Non-CTA Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CT angiography(CTA)

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Qianfoshan Hospital

OTHER

Sponsor Role collaborator

Yantai Yuhuangding Hospital

OTHER

Sponsor Role collaborator

Weifang Medical University

OTHER

Sponsor Role collaborator

Weifang People's Hospital

OTHER

Sponsor Role collaborator

Jining First People's Hospital

OTHER

Sponsor Role collaborator

Weihai Municipal Hospital

OTHER

Sponsor Role collaborator

Weihai Central Hospital

OTHER

Sponsor Role collaborator

Dongying People's Hospital

OTHER

Sponsor Role collaborator

Rizhao People's Hospital

OTHER

Sponsor Role collaborator

People's Hospital of Jimo District, Qingdao

UNKNOWN

Sponsor Role collaborator

Liaocheng People's Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhou Yanbing, MD

Role: STUDY_DIRECTOR

The Affiliated Hospital of Qingdao University

Locations

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Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital

Qingdao, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhou Yanbing, MD

Role: CONTACT

Phone: 86532-82911324

Email: [email protected]

Meng Cheng, MD

Role: CONTACT

Phone: 86532-82911324

Email: [email protected]

Facility Contacts

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Zhou Yanbing

Role: primary

References

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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.

Reference Type DERIVED
PMID: 39786664 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34895320 (View on PubMed)

Other Identifiers

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QYFYKYLL791311920

Identifier Type: -

Identifier Source: org_study_id