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The Origin of Infrapyloric Artery (IPA-Origin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071237
Recruitment Status : Completed
First Posted : March 6, 2017
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Jiafu Ji, Peking University

Brief Summary:
Infrapyloric artery(IPA) is of great importance for gastric cancer patients. According to previous study, the origin of IPA varies greatly among different studies. This trial aims to tell the distribution of IPA origin in Chinese patients.

Condition or disease Intervention/treatment
Stomach Neoplasm Procedure: Gastrectomy

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.

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Study Type : Observational
Actual Enrollment : 429 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Origin of Infrapyloric Artery: an Observational Trial
Actual Study Start Date : March 4, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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.
Procedure: Gastrectomy
Patients with gastric cancer that needs receiving total or distal gastrectomy. During the surgery, IPA needs to be exposed and transected.
Other Name: surgery




Primary Outcome Measures :
  1. Distribution of IPA origin [ Time Frame: Immediately after surgery ]
    The percentage of IPA origin from GDA, ASPDA and RGEA.


Secondary Outcome Measures :
  1. Reconstruction rate of IPA by CT scan [ Time Frame: Immediately after the reconstruction of CT scan. ]
    The rate of identification of IPA origin by reconstruction of CT scan.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with gastric cancer who needs to receive total or distal gastrectomy.
Criteria

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.

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): NCT03071237


Locations
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China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Peking University
Investigators
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Principal Investigator: Ziyu Li, M.D. Gastrointestinal Cancer Center, Peking University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jiafu Ji, MD, Peking University
ClinicalTrials.gov Identifier: NCT03071237    
Other Study ID Numbers: 2017YJZ07
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiafu Ji, Peking University:
infrapyloric artery
gastric cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases