NCT03071237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
429

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

March 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

March 1, 2017

Last Update Submit

February 17, 2019

Conditions

Stomach Neoplasm

Keywords

infrapyloric arterygastric cancer

Outcome Measures

Primary Outcomes (1)

  • Distribution of IPA origin

    The percentage of IPA origin from GDA, ASPDA and RGEA.

    Immediately after surgery

Secondary Outcomes (1)

  • Reconstruction rate of IPA by CT scan

    Immediately after the reconstruction of CT scan.

Study Arms (1)

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

Interventions

GastrectomyPROCEDURE

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

Also known as: surgery
Observational group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with gastric cancer who needs to receive total or distal gastrectomy.

You may qualify if:

  • Patients with gastric cancer who needs to receive total or distal gastrectomy.
  • Signed informed consent

You may not qualify if:

  • IPA not dissected, photo-taken or video-recorded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (3)

  • 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.

    PMID: 25228163BACKGROUND

  • 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.

    PMID: 23314832BACKGROUND

  • 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.

    PMID: 30510361DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

GastrectomySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures

Study Officials

  • Ziyu Li, M.D.

    Gastrointestinal Cancer Center, Peking University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 6, 2017

Study Start

March 4, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

February 19, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)