Stomach NeoplasmIPA-OriginNCT03071237
The Origin of Infrapyloric Artery
An observational study of Stomach Neoplasm, run by Peking University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasm
- What is being tested?
- Gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 429 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2017to 31 Dec 2017
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients with gastric cancer who needs to receive total or distal gastrectomy.
Who may be able to join
- Patients with gastric cancer who needs to receive total or distal gastrectomy.
- Signed informed consent
Who cannot join
- IPA not dissected, photo-taken or video-recorded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Origin of Infrapyloric Artery: an Observational Trial
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.
Read the 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.
- Conditions
- Stomach Neoplasm
- Being tested
- Gastrectomy
- Keywords
- infrapyloric artery, gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastrectomyProcedure or surgery
Also called surgery
Patients with gastric cancer that needs receiving total or distal gastrectomy. During the surgery, IPA needs to be exposed and transected.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of IPA origin
The percentage of IPA origin from GDA, ASPDA and RGEA.
Measured: Immediately after surgery
Secondary outcomes (1)
Reconstruction rate of IPA by CT scan
The rate of identification of IPA origin by reconstruction of CT scan.
Measured: Immediately after the reconstruction of CT scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start4 Mar 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiafu Ji, Peking University
- Investigators
- Ziyu Li, M.D., Principal investigator, Gastrointestinal Cancer Center, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071237
- Sponsor's protocol ID
- 2017YJZ07
- Acronym
- IPA-Origin
- Status last verified
- Feb 2019
- First submitted
- 1 Mar 2017
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25228163Shinohara 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.
PubMed 23314832Miao 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.
PubMed 30510361
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Origin of Infrapyloric Artery: an Observational Trial
- ClinicalTrials.gov ID
- NCT03071237
- Acronym / sponsor ID
- IPA-Origin / 2017YJZ07
- Conditions
- Stomach Neoplasm
- Keywords
- infrapyloric artery, gastric cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 4 Mar 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 6 Mar 2017 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Procedure: GastrectomyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with gastric cancer who needs to receive total or distal gastrectomy.
Key inclusion criteria (2 listed)
- Patients with gastric cancer who needs to receive total or distal gastrectomy.
- Signed informed consent
Key exclusion criteria (1 listed)
- IPA not dissected, photo-taken or video-recorded.
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 |
|---|---|---|
| GastrectomyAlso: surgeryPatients with gastric cancer that needs receiving total or distal gastrectomy. During the surgery, IPA needs to be exposed and transected. | Procedure or surgery | Observational group |
Primary outcome
Distribution of IPA origin
Time frame: Immediately after surgery
The percentage of IPA origin from GDA, ASPDA and RGEA.
1 secondary outcome
Reconstruction rate of IPA by CT scan
Time frame: Immediately after the reconstruction of CT scan.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Background: PubMed 25228163Haruta 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.
- Background: PubMed 23314832Shinohara 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.
- Derived from this study: PubMed 30510361Miao 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.
- Individual participant dataSharing planned: No
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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.
Ziyu Li, M.D. principal investigator
Gastrointestinal Cancer Center, Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasm, run by Peking 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 19 Feb 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of IPA origin (time frame: Immediately after 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 NCT03071237, which also lists 3 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 19 Feb 2019.