Defining Benchmarks for Gastric Cancer Patients Underwent Minimal Invasive Gastrectomy

NCT06938139 | Active Not Recruiting DMC

• 1 other identifier: Benchmark-MISGC
• Study Type: observational
• Target: 90,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Adenocarcinoma; Surgery, Laparoscopic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Benchmark values of Overall survival (OS)

  1-year, 2-year and 3-year

• Benchmark values of Disease-specific survival (DSS)

  1-year, 2-year, and 3-year

• benchmark value of the number of harvest lymph nodes

  1 month

• Benchmark values of Mortality rates

  30 days

• Benchmark values of the incidence of intraoperative complications

  1 days

Interventions

None-placebo OTHER

None, observational study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• ASA class \> 3;
• remnant gastric cancer;
• concurrent/previous malignant disease;
• Distant metastasis;
• Palliative resection;
• Abodominal exploration.

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian medical university union hospital

Fuzhou, Fujian, 350000, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastric Surgery department

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 22, 2025
• Study Start: March 1, 2025
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

CN (1)