Defining Benchmarks for Gastric Cancer Patients Underwent Minimal Invasive Gastrectomy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gastric Adenocarcinoma; Surgery, Laparoscopic
• Intervention / Treatment: Other: None-placebo

• Study Type: Observational
• Enrollment (Estimated): 90000

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. Patients with postoperative histologically confirmed gastric adenocarcinoma at stages T1-4a, N0/+, M0;
2. underwent robotic or laparoscopic gastrectomies with curative intent

Exclusion Criteria:

1. ASA class > 3;
2. remnant gastric cancer;
3. concurrent/previous malignant disease;
4. Distant metastasis;
5. Palliative resection;
6. Abodominal exploration.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1-year, 2-year, and 3-year
benchmark value of the number of harvest lymph nodes	the number of harvest lymph nodes	1 month
Benchmark values of Mortality rates	Patient died during hospitalization.	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	1 days
Benchmark values of Intraoperative blood loss	Intraoperative blood loss	1 day
Benchmark values of operation time	From skin incision to skin closure	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.	30 days

Collaborators and Investigators

• Sponsor: Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: April 20, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma
• Other Study ID Numbers: Benchmark-MISGC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No