- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03071237
The Origin of Infrapyloric Artery (IPA-Origin)
The Origin of Infrapyloric Artery: an Observational Trial
Study Overview
Detailed Description
Infrapyloric artery(IPA) is of great importance for gastric cancer patients. In early gastric cancer patients, the pylorus-preserving gastrectomy requires the preserving of IPA. In advanced gastric cancer patients, the subgroup of No. 6 lymph node might be associated with IPA. In Japanese Gastric Cancer Association(JGCA) gastric cancer classification guidelines, the No. 6 lymph nodes is defined as lymph nodes along the first branch and proximal part of the right gastroepiploic artery(RGEA) down to the confluence of the right gastroepiploic vein and the anterior superior pancreatoduodenal vein. However,if IPA origins from the gastroduodenal artery(GDA) or anterior superior pancreatoduodenal artery(ASPDA), the lymph nodes along the IPA can not be grouped into the No. 6 lymph nodes. Thus, a new definition of No. 6 lymph nodes is needed on the basis of the origin of IPA.
Previous studies about IPA origin are few and the origin of IPA varies greatly among different studies.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100142
- Beijing Cancer hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with gastric cancer who needs to receive total or distal gastrectomy.
- Signed informed consent
Exclusion Criteria:
- IPA not dissected, photo-taken or video-recorded.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational group
Patients who would receive total gastrectomy or distal gastrectomy are enrolled in to the study and this group.
An optional reconstruction of IPA by enhanced CT scan can be performed before surgery but not a definite require.
During the operation, IPA origin location will be photo-taken or video-recorded before its transection.
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Patients with gastric cancer that needs receiving total or distal gastrectomy.
During the surgery, IPA needs to be exposed and transected.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Distribution of IPA origin
Time Frame: Immediately after surgery
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The percentage of IPA origin from GDA, ASPDA and RGEA.
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Immediately after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reconstruction rate of IPA by CT scan
Time Frame: Immediately after the reconstruction of CT scan.
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The rate of identification of IPA origin by reconstruction of CT scan.
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Immediately after the reconstruction of CT scan.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ziyu Li, M.D., Gastrointestinal Cancer Center, Peking University
Publications and helpful links
General Publications
- Haruta S, Shinohara H, Ueno M, Udagawa H, Sakai Y, Uyama I. Anatomical considerations of the infrapyloric artery and its associated lymph nodes during laparoscopic gastric cancer surgery. Gastric Cancer. 2015 Oct;18(4):876-80. doi: 10.1007/s10120-014-0424-5. Epub 2014 Sep 17.
- Shinohara H, Kurahashi Y, Kanaya S, Haruta S, Ueno M, Udagawa H, Sakai Y. Topographic anatomy and laparoscopic technique for dissection of no. 6 infrapyloric lymph nodes in gastric cancer surgery. Gastric Cancer. 2013 Oct;16(4):615-20. doi: 10.1007/s10120-012-0229-3. Epub 2013 Jan 13.
- Miao R, Qu J, Li Z, Wang D, Yu J, Zang W, Li Y, Liu F, Zhang J, Song W, Ye K, Yan S, Wang W, Ren S, Zang L, Jing C, Zhang L, Wang K, Fu W, Fan L, Liang B, Zhao G, Cai J, Yang L, Zhu J, You J, Yang K, Huang Q, Niu Z, Ning N, Qiu X, Ji G, Liang F, Huang H, Gao C, Shan F, Li S, Jia Y, Zhang L, Ying X, Zhang Y, Bu Z, Su X, Zhao G, Li Z, Ji J. Anatomical variation of infra-pyloric artery origination: A prospective multicenter observational study (IPA-Origin). Chin J Cancer Res. 2018 Oct;30(5):500-507. doi: 10.21147/j.issn.1000-9604.2018.05.03.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017YJZ07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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