Gastric CarcinomaNCT07139418
The Clinical Significance of Examining Metastatic Lymph Nodes in Individual Gastric Mesenteries in the Patients With Gastric Cancer Undergoing Gastrectomy
An observational study of Gastric Carcinoma, run by Jichao Qin at 1 site in China.
Trial summary
This study aims to examine the predictive value of metastatic gastric mesenteries, which contains metastatic lymph node, in 6 gastric mesenteries; and importantly, to further evaluate the relationship between the number of metastatic gastric mesenteries and prognosis in the gastric cancer patients who received… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastric Carcinoma
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 7 Oct 2025to 30 Aug 2030
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who met the above inclusion and exclusion criteria
Who may be able to join
- Aged older than 18 years and younger than 85 years
- Primary gastric adenocarcinoma confirmed by preoperative pathology result
- cT2-4aN0-3M0 at preoperative evaluation according to the American Joint 8 Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- Patients who received gastrectomy with D2 lymphadenectomy plus complete mesogastric excision
- American Society of Anesthesiologists (ASA) class I, II, or III
- Written informed consent
Who cannot join
- Negative preoperative biopsy
- Too late tumour stage or metastasis (cT4b/M1)
- BMI>30 kg/m2
- Total gastrectomy or proximal gastrectomy
- previous neoadjuvant chemotherapy or radiotherapy
- Previous upper abdominal surgery
- Combined with other malignant diseases
- Reject operation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Tao Wang, Ph.D, +86-197-068-25286, 15002740874@163.com
About this study
Official title: The Clinical Significance of Examining Metastatic Lymph Nodes in Respective Gastric Mesenteries in the Gastric Cancer Patients Who Received D2 Lymphadenectomy Plus Complete Mesogastric Excision
This study aims to examine the predictive value of metastatic gastric mesenteries, which contains metastatic lymph node, in 6 gastric mesenteries; and importantly, to further evaluate the relationship between the number of metastatic gastric mesenteries and prognosis in the gastric cancer patients who received D2+complete mesogastric excision (CME).
Read the detailed description
Prior to 2010, the gastric cancer nodal staging systems primarily consisted of two approaches: the UICC/AJCC classification (by the International Union Against Cancer/American Joint Committee on Cancer), which was based principally on the number of metastatic lymph nodes; and the JGCA system (by the Japanese Gastric Cancer Association), which focused on the anatomical location of metastatic lymph nodes. However, a landmark unification occurred in the 14th edition of the Japanese Classification of Gastric Carcinoma (2010), where the anatomically based nodal staging was abolished in favor of a metastasis-counting method. This harmonization with the UICC/AJCC system established a globally authoritative standard for evaluating therapeutic outcomes in gastric cancer, representing a milestone advancement in clinical research.
The current staging standard for gastric cancer follows the 8th edition TNM classification system (effective in 2017) jointly established by the UICC and AJCC, which primarily evaluates tumor invasion depth (T), lymph node metastasis extent (N), and distant metastasis status (M). By integrating these three parameters, gastric cancer is classified into stages 0 through IV to guide treatment decisions and prognostic assessment. The gastric mesentery contains vascular, adipose, neural, and lymphoid tissues and can be anatomically divided into the left gastric mesentery, right gastric mesentery, left gastroepiploic mesentery, right gastroepiploic mesentery, posterior gastric mesentery, and short gastric mesentery. Although the anatomical location of metastatic lymph nodes is no longer included in the current gastric cancer staging system, our institutional research has demonstrated that, among patients with the same N-stage, those with a greater number of metastatic gastric mesenteries exhibit worse prognosis, indicating that the anatomical distribution of metastatic lymph nodes remains clinically significant for gastric cancer outcomes. This study proposes to examine lymph nodes in individual gastric mesenteries in the clinical specimens in the patients with gastric cancer who received D2+CME. Compared to the lymph node grouping described in the 15th edition of the Japanese Gastric Cancer Association's "Japanese Classification of Gastric Carcinoma" (2017), 16 groups of lymph nodes or more need to be separately examined, implying that this work is labor consuming. In contrast, in our system, the lymph nodes in only maximum to 6 gastric mesenteries need to be respectively examined, which will greatly decrease labor. And importantly, our system integrates the information of anatomical location of metastatic lymph nodes. By examining metastatic lymph nodes in individual gastric mesenteries, we aim to further investigate the relationship between the location and/or the number of metastatic gastric mesenteries and prognosis in the patients with gastric cancer.
- Conditions
- Gastric Carcinoma
- Keywords
- Gastric cancer, Complete mesogastric excision, Gastric mesentery, Lymph node metastasis
- Medical subject headings
- Stomach Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| D2+CME surgery for gastric cancer | D2 lymphadenectomy plus complete mesogastric excision in gastric cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Prognostic impact of lymph node-positive mesenteric count in gastric cancer
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start7 Oct 2025
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastric CarcinomaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Jichao Qin
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University
- Responsible party
- Sponsor-investigator, Jichao Qin, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139418
- Sponsor's protocol ID
- zywxm001
- Status last verified
- Mar 2026
- First submitted
- 17 Aug 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xie D, Gao C, Lu A, Liu L, Yu C, Hu J, Gong J. Proximal segmentation of the dorsal mesogastrium reveals new anatomical implications for laparoscopic surgery. Sci Rep. 2015 Nov 6;5:16287. doi: 10.1038/srep16287.
PubMed 26542081Xie D, Wang Y, Shen J, Hu J, Yin P, Gong J. Detection of carcinoembryonic antigen in peritoneal fluid of patients undergoing laparoscopic distal gastrectomy with complete mesogastric excision. Br J Surg. 2018 Oct;105(11):1471-1479. doi: 10.1002/bjs.10881. Epub 2018 Jul 2.
PubMed 29964324Xie D, Liu L, Osaiweran H, Yu C, Sheng F, Gao C, Hu J, Gong J. Detection and Characterization of Metastatic Cancer Cells in the Mesogastrium of Gastric Cancer Patients. PLoS One. 2015 Nov 13;10(11):e0142970. doi: 10.1371/journal.pone.0142970. eCollection 2015.
PubMed 26566136Xie D, Shen J, Liu L, Cao B, Wang Y, Qin J, Wu J, Yan Q, Hu Y, Yang C, Cao Z, Hu J, Yin P, Gong J. Complete mesogastric excision for locally advanced gastric cancer: short-term outcomes of a randomized clinical trial. Cell Rep Med. 2021 Mar 16;2(3):100217. doi: 10.1016/j.xcrm.2021.100217. eCollection 2021 Mar 16.
PubMed 33763656
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Significance of Examining Metastatic Lymph Nodes in Respective Gastric Mesenteries in the Gastric Cancer Patients Who Received D2 Lymphadenectomy Plus Complete Mesogastric Excision
- ClinicalTrials.gov ID
- NCT07139418
- Acronym / sponsor ID
- zywxm001
- Conditions
- Gastric Carcinoma
- Keywords
- Gastric cancer, Complete mesogastric excision, Gastric mesentery, Lymph node metastasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Jichao QinUniversity, hospital or other
- Collaborators
- Zhejiang University
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 24 Aug 2025 (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.
This study aims to examine the predictive value of metastatic gastric mesenteries, which contains metastatic lymph node, in 6 gastric mesenteries; and importantly, to further evaluate the relationship between the number of metastatic gastric mesenteries and prognosis in the gastric cancer patients who received D2+complete mesogastric excision (CME).
Detailed description
Prior to 2010, the gastric cancer nodal staging systems primarily consisted of two approaches: the UICC/AJCC classification (by the International Union Against Cancer/American Joint Committee on Cancer), which was based principally on the number of metastatic lymph nodes; and the JGCA system (by the Japanese Gastric Cancer Association), which focused on the anatomical location of metastatic lymph nodes. However, a landmark unification occurred in the 14th edition of the Japanese Classification of Gastric Carcinoma (2010), where the anatomically based nodal staging was abolished in favor of a metastasis-counting method. This harmonization with the UICC/AJCC system established a globally authoritative standard for evaluating therapeutic outcomes in gastric cancer, representing a milestone advancement in clinical research.
The current staging standard for gastric cancer follows the 8th edition TNM classification system (effective in 2017) jointly established by the UICC and AJCC, which primarily evaluates tumor invasion depth (T), lymph node metastasis extent (N), and distant metastasis status (M). By integrating these three parameters, gastric cancer is classified into stages 0 through IV to guide treatment decisions and prognostic assessment. The gastric mesentery contains vascular, adipose, neural, and lymphoid tissues and can be anatomically divided into the left gastric mesentery, right gastric mesentery, left gastroepiploic mesentery, right gastroepiploic mesentery, posterior gastric mesentery, and short gastric mesentery. Although the anatomical location of metastatic lymph nodes is no longer included in the current gastric cancer staging system, our institutional research has demonstrated that, among patients with the same N-stage, those with a greater number of metastatic gastric mesenteries exhibit worse prognosis, indicating that the anatomical distribution of metastatic lymph nodes remains clinically significant for gastric cancer outcomes. This study proposes to examine lymph nodes in individual gastric mesenteries in the clinical specimens in the patients with gastric cancer who received D2+CME. Compared to the lymph node grouping described in the 15th edition of the Japanese Gastric Cancer Association's "Japanese Classification of Gastric Carcinoma" (2017), 16 groups of lymph nodes or more need to be separately examined, implying that this work is labor consuming. In contrast, in our system, the lymph nodes in only maximum to 6 gastric mesenteries need to be respectively examined, which will greatly decrease labor. And importantly, our system integrates the information of anatomical location of metastatic lymph nodes. By examining metastatic lymph nodes in individual gastric mesenteries, we aim to further investigate the relationship between the location and/or the number of metastatic gastric mesenteries and prognosis in the patients with gastric cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D2+CME surgery for gastric cancer | – | –D2 lymphadenectomy plus complete mesogastric excision in gastric cancer patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who met the above inclusion and exclusion criteria
Key inclusion criteria (6 listed)
- Aged older than 18 years and younger than 85 years
- Primary gastric adenocarcinoma confirmed by preoperative pathology result
- cT2-4aN0-3M0 at preoperative evaluation according to the American Joint 8 Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- Patients who received gastrectomy with D2 lymphadenectomy plus complete mesogastric excision
- American Society of Anesthesiologists (ASA) class I, II, or III
Key exclusion criteria (8 listed)
- Negative preoperative biopsy
- Too late tumour stage or metastasis (cT4b/M1)
- BMI>30 kg/m2
- Total gastrectomy or proximal gastrectomy
- previous neoadjuvant chemotherapy or radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall survival
Time frame: through study completion, an average of 3 year
Prognostic impact of lymph node-positive mesenteric count in gastric cancer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Results publication: PubMed 26542081Xie D, Gao C, Lu A, Liu L, Yu C, Hu J, Gong J. Proximal segmentation of the dorsal mesogastrium reveals new anatomical implications for laparoscopic surgery. Sci Rep. 2015 Nov 6;5:16287. doi: 10.1038/srep16287.
- Results publication: PubMed 29964324Xie D, Wang Y, Shen J, Hu J, Yin P, Gong J. Detection of carcinoembryonic antigen in peritoneal fluid of patients undergoing laparoscopic distal gastrectomy with complete mesogastric excision. Br J Surg. 2018 Oct;105(11):1471-1479. doi: 10.1002/bjs.10881. Epub 2018 Jul 2.
- Results publication: PubMed 26566136Xie D, Liu L, Osaiweran H, Yu C, Sheng F, Gao C, Hu J, Gong J. Detection and Characterization of Metastatic Cancer Cells in the Mesogastrium of Gastric Cancer Patients. PLoS One. 2015 Nov 13;10(11):e0142970. doi: 10.1371/journal.pone.0142970. eCollection 2015.
- Results publication: PubMed 33763656Xie D, Shen J, Liu L, Cao B, Wang Y, Qin J, Wu J, Yan Q, Hu Y, Yang C, Cao Z, Hu J, Yin P, Gong J. Complete mesogastric excision for locally advanced gastric cancer: short-term outcomes of a randomized clinical trial. Cell Rep Med. 2021 Mar 16;2(3):100217. doi: 10.1016/j.xcrm.2021.100217. eCollection 2021 Mar 16.
- Individual participant dataSharing planned: Undecided
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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.
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 Gastric Carcinoma, run by Jichao Qin 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 11 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Wang, Ph.d (+86-197-068-25286, 15002740874@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: through study completion, an average of 3 year). 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 NCT07139418, which also lists 4 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 11 Mar 2026.