Gastric AdenocarcinomaNCT06938139
Defining Benchmarks for Gastric Cancer Patients Underwent Minimal Invasive Gastrectomy
An observational study of Gastric Adenocarcinoma and Surgery, Laparoscopic, run by Fujian Medical University at 1 site in China.
Trial summary
The Benchmark-MISGC study was a large-scale retrospective observational study launched by the China Gastric Cancer Surgical Union, aiming to establish the benchmarks of the short- and long-term outcomes for gastric cancer patients who underwent minimal invasive gastrectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Adenocarcinoma, Surgery, Laparoscopic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 30 Apr 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with postoperative histologically confirmed gastric adenocarcinoma at stages T1-4a, N0/+, M0 and treated with robotic or laparoscopic gastrectomies with curative intent along with lymph node dissection between January 2009 and April 2024.
Who may be able to join
- Patients with postoperative histologically confirmed gastric adenocarcinoma at stages T1-4a, N0/+, M0;
- underwent robotic or laparoscopic gastrectomies with curative intent
Who cannot join
- ASA class > 3;
- remnant gastric cancer;
- concurrent/previous malignant disease;
- Distant metastasis;
- Palliative resection;
- Abodominal exploration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Defining Benchmarks for Gastric Cancer Patients Underwent Minimal Invasive Gastrectomy: A Multicentre Analysis
The Benchmark-MISGC study was a large-scale retrospective observational study launched by the China Gastric Cancer Surgical Union, aiming to establish the benchmarks of the short- and long-term outcomes for gastric cancer patients who underwent minimal invasive gastrectomy.
- Conditions
- Gastric Adenocarcinoma, Surgery, Laparoscopic
- Being tested
- None-placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None-placeboOther
None, observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Benchmark values of overall complication
Median values of continuous variables and the proportions of categorical variables were calculated per participating centre. Benchmark values, indicating 'best achievable' results for each outcome indicator, were set at the 25th percentile for positive parameters (for example lymph node yield) or the 75th percentile for negative parameters (for example complications) of the centers' median values. Postoperative complications were evaluated within 30 days following surgery. These postoperative complications include gastrointestinal-related complications, incision-related complications, respiratory complications, cardiovascular and cerebrovascular complications, urinary system complications, infection complications, embolism complications, and other complications. The grading of postoperative complications adopts the Clavien-Dindo classification.
Measured: 30 days
Secondary outcomes (8)
Benchmark values of Overall survival (OS)
Benchmark values of 1-year, 2-year and 3-year OS. OS was defined as the time from surgery to death from any cause or last follow-up.
Measured: 1-year, 2-year and 3-year
Benchmark values of Disease-specific survival (DSS)
Benchmark values of 1-year, 2-year and 3-year DSS. DSS was defined as the time from surgery to death from gastric cancer, or last follow-up.
Measured: 1-year, 2-year, and 3-year
benchmark value of the number of harvest lymph nodes
the number of harvest lymph nodes
Measured: 1 month
Benchmark values of Mortality rates
Patient died during hospitalization.
Measured: 30 days
Benchmark values of the incidence of intraoperative complications
Intraoperative complications were defined as bleeding due to named vessel injury, injury to visceral organs, mechanical factor-related problems, cardiopulmonary dysfunction due to hypercapnia, and other complications
Measured: 1 days
Benchmark values of Intraoperative blood loss
Intraoperative blood loss
Measured: 1 day
Benchmark values of operation time
From skin incision to skin closure
Measured: 1 day
Benchmark values of textbook Outcome
Textbook outcome (TO) was defined based on review of existing TO metrics in the literature including outcomes such as complete-potentially curative status, no intraoperative complications, no eventful postoperative complications (Clavien-Dindo grade III or higher), 15 lymph nodes(LNs) examined, hospital stay < 21days, no reintervention (surgical, endoscopic or radiological) within 30 days after surgery, no readmission to the intensive care unit (ICU) within 30 days after surgery, no postoperative mortality within 30 days after surgery, and no hospital readmission within 30 days after discharge. When all nine desired health outcomes were realized, TO was achieved.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 Mar 2025
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Medical 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938139
- Sponsor's protocol ID
- Benchmark-MISGC
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2025
- Last updated
- 22 Apr 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 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Benchmarks for Gastric Cancer Patients Underwent Minimal Invasive Gastrectomy: A Multicentre Analysis
- ClinicalTrials.gov ID
- NCT06938139
- Acronym / sponsor ID
- Benchmark-MISGC
- Conditions
- Gastric Adenocarcinoma, Surgery, Laparoscopic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90,000 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 22 Apr 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.
The Benchmark-MISGC study was a large-scale retrospective observational study launched by the China Gastric Cancer Surgical Union, aiming to establish the benchmarks of the short- and long-term outcomes for gastric cancer patients who underwent minimal invasive gastrectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with postoperative histologically confirmed gastric adenocarcinoma at stages T1-4a, N0/+, M0 and treated with robotic or laparoscopic gastrectomies with curative intent along with lymph node dissection between January 2009 and April 2024.
Key inclusion criteria (2 listed)
- Patients with postoperative histologically confirmed gastric adenocarcinoma at stages T1-4a, N0/+, M0;
- underwent robotic or laparoscopic gastrectomies with curative intent
Key exclusion criteria (6 listed)
- ASA class > 3;
- remnant gastric cancer;
- concurrent/previous malignant disease;
- Distant metastasis;
- Palliative resection;
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 |
|---|---|---|
| None-placeboNone, observational study | Other | – |
Primary outcome
Benchmark values of overall complication
Time frame: 30 days
Median values of continuous variables and the proportions of categorical variables were calculated per participating centre. Benchmark values, indicating 'best achievable' results for each outcome indicator, were set at the 25th percentile for positive parameters (for example lymph node yield) or the 75th percentile for negative parameters (for example complications) of the centers' median values. Postoperative complications were evaluated within 30 days following surgery. These postoperative complications include gastrointestinal-related complications, incision-related complications, respiratory complications, cardiovascular and cerebrovascular complications, urinary system complications, infection complications, embolism complications, and other complications. The grading of postoperative complications adopts the Clavien-Dindo classification.
8 secondary outcomes
Benchmark values of Overall survival (OS)
Time frame: 1-year, 2-year and 3-year
Benchmark values of Disease-specific survival (DSS)
Time frame: 1-year, 2-year, and 3-year
benchmark value of the number of harvest lymph nodes
Time frame: 1 month
Benchmark values of Mortality rates
Time frame: 30 days
Benchmark values of the incidence of intraoperative complications
Time frame: 1 days
Benchmark values of Intraoperative blood loss
Time frame: 1 day
Benchmark values of operation time
Time frame: 1 day
Benchmark values of textbook Outcome
Time frame: 30 days
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 22 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Adenocarcinoma and Surgery, Laparoscopic, run by Fujian Medical 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 6 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 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?
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?
Benchmark values of overall complication (time frame: 30 days). 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 22 Apr 2025.