Gastric Carcinomazydgc001NCT06736847
Exploration of Lymph Node Metastasis and Tumor Deposit in the Posterior Gastric Mesentery for Distal Gastric Cancer
An observational study of Gastric Carcinoma, run by Jichao Qin at 1 site in China.
Trial summary
This study aims to evaluate lymph node metastasis and tumor deposit in the posterior gastric mesentery following distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastric Carcinoma
- What is being tested?
- distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 Dec 2027
- 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
- cT2-4N0-3M0 at preoperative evaluation according to the American Joint 8 Committee on Cancer (AJCC) Cancer Staging Manual 7th Edition
- Patients who received distal 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: Exploration of Lymph Node Metastasis and Tumor Deposit in the Posterior Gastric Mesentery Following D2 Lymphadenectomy Plus Complete Mesogastric Excision in Patients Who Received Distal Gastrectomy: A Prospective Observational Study
This study aims to evaluate lymph node metastasis and tumor deposit in the posterior gastric mesentery following distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer.
Read the detailed description
Since 1997, the AJCC has been using the number of lymph node metastases (pN staging) as a crucial indicator to assess the prognosis of gastric cancer patients. This system has been continuously updated, widely accepted by the global oncology community, and confirmed for its feasibility, applicability, convenience, and reproducibility. The number of metastatic lymph nodes in radical resection specimens of gastric cancer patients is the total count of lymph nodes with metastasis and is a key focus of postoperative pathological examination. D2 lymphadenectomy has become the standard operative procedure for advanced resectable gastric cancer and certain early-stage gastric cancers (diagnosed preoperatively with lymph node metastases). For advanced gastric cancer, there is growing evidence that the ideal surgical approach should involve D2 lymphadenectomy plus CME. In distal gastrectomy, the number of lymph nodes removed in D2 lymphadenectomy plus CME is significantly higher than in D2 dissection. Additionally, patients in the D2+CME group exhibit better long-term outcomes compared to the D2 group (DCGC01 study). Performing D2+CME surgery for distal gastric cancer involves the resection of the five major mesentery, including the posterior gastric mesentery, which may aid in thorough lymph node clearance and reduce cancer spillage. The posterior gastric mesentery comprises the No.11p and part of the No.11d lymph nodes. However, only the No.11p lymph nodes are resected in traditional D2 lymphadenectomy, resulting in incomplete lymph node clearance and postoperative tumor recurrence. Hence, the primary objective of this study is to examine lymph node metastasis in the posterior gastric mesentery following D2+CME in patients undergoing distal gastrectomy, aiming to offer evidence-based medical insights for standardizing surgical approaches in gastric cancer management.
- Conditions
- Gastric Carcinoma
- Being tested
- distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer
- Keywords
- Gastric cancer, Lymph node dissection, Posterior 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.
distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancerProcedure or surgery
distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer
| Study group | Role | What they receive |
|---|---|---|
| Radical gastrectomy with membrane dissection | Not described Receives: Procedure: distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of lymph node metastasis and tumor deposit in the posterior gastric mesentery
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 May 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 200 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Jichao Qin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jichao Qin, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736847
- Sponsor's protocol ID
- 2024-0899
- Acronym
- zydgc001
- Status last verified
- Aug 2025
- First submitted
- 1 Sep 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Lymph Node Metastasis and Tumor Deposit in the Posterior Gastric Mesentery Following D2 Lymphadenectomy Plus Complete Mesogastric Excision in Patients Who Received Distal Gastrectomy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06736847
- Acronym / sponsor ID
- zydgc001 / 2024-0899
- Conditions
- Gastric Carcinoma
- Keywords
- Gastric cancer, Lymph node dissection, Posterior gastric mesentery, Lymph node metastasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jichao QinUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Dec 2024 (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 evaluate lymph node metastasis and tumor deposit in the posterior gastric mesentery following distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer.
Detailed description
Since 1997, the AJCC has been using the number of lymph node metastases (pN staging) as a crucial indicator to assess the prognosis of gastric cancer patients. This system has been continuously updated, widely accepted by the global oncology community, and confirmed for its feasibility, applicability, convenience, and reproducibility. The number of metastatic lymph nodes in radical resection specimens of gastric cancer patients is the total count of lymph nodes with metastasis and is a key focus of postoperative pathological examination. D2 lymphadenectomy has become the standard operative procedure for advanced resectable gastric cancer and certain early-stage gastric cancers (diagnosed preoperatively with lymph node metastases). For advanced gastric cancer, there is growing evidence that the ideal surgical approach should involve D2 lymphadenectomy plus CME. In distal gastrectomy, the number of lymph nodes removed in D2 lymphadenectomy plus CME is significantly higher than in D2 dissection. Additionally, patients in the D2+CME group exhibit better long-term outcomes compared to the D2 group (DCGC01 study). Performing D2+CME surgery for distal gastric cancer involves the resection of the five major mesentery, including the posterior gastric mesentery, which may aid in thorough lymph node clearance and reduce cancer spillage. The posterior gastric mesentery comprises the No.11p and part of the No.11d lymph nodes. However, only the No.11p lymph nodes are resected in traditional D2 lymphadenectomy, resulting in incomplete lymph node clearance and postoperative tumor recurrence. Hence, the primary objective of this study is to examine lymph node metastasis in the posterior gastric mesentery following D2+CME in patients undergoing distal gastrectomy, aiming to offer evidence-based medical insights for standardizing surgical approaches in gastric cancer management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radical gastrectomy with membrane dissection | – | Procedure: distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer |
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
- cT2-4N0-3M0 at preoperative evaluation according to the American Joint 8 Committee on Cancer (AJCC) Cancer Staging Manual 7th Edition
- Patients who received distal 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancerdistal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer | Procedure or surgery | Radical gastrectomy with membrane dissection |
Primary outcome
Rate of lymph node metastasis and tumor deposit in the posterior gastric mesentery
Time frame: through study completion, an average of 1 year
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 2 Sep 2025.
- 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 2 Sep 2025. 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?
Rate of lymph node metastasis and tumor deposit in the posterior gastric mesentery (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2025.