Early Gastric Cancer
Conditions
Keywords
early gastric cancer, endoscopic submucosal dissection, surgery
Brief summary
In this study, patients who are going to undergo endoscopic submucosal dissection (ESD) or surgery for early gastric cancer will be enrolled and divided into ESD group and Surgery group according to the procedure they go through. The patients will be followed up for at least 5 years after ESD or surgery. Esophagogastroduodenoscopy (EDG) and biopsy will be performed 3 months and then 6 months after ESD or surgery. Thereafter, EDG will be performed along with biopsy and abdominal computed tomography annually up to 5 years. Patients' data such as age, sex, clinical diagnosis, achievement of en-bloc resection, pathological outcomes, complications and survival condition will be prospectively collected. Statistical methods such as Student's t-test, the chi-square test, the Kaplan-Meier method and the log-rank test will be used to compare the short term and long term outcomes between the ESD group and the surgery group.
Interventions
PROCEDUREendoscopic submucosal dissection
Endoscopic submucosal dissection is an endoscopic procedure which can achieve en bloc resection of GI tumor. ESD is characterized by three steps: injecting fluid into the submucosa to elevate the lesion from the muscle layer, circumferential cutting of the surrounding mucosa of the lesion, and subsequent dissection of the connective tissue of the submucosa beneath the lesion. The ESD procedure will be carried out by experienced endoscopists.
PROCEDURESurgery
Surgery for EGC include Distal, proximal, or total gastrectomy, which will be performed according to the location and macroscopic tumor type by experienced surgeons.
Sponsors
Peking University Third Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Clinically diagnosed as early gastric cancer * Willing to undergo endoscopic submucosal dissection or surgery for the treatment of early gastric cancer
Exclusion criteria
* Advanced stage gastric cancer * Not willing to undergo endoscopic submucosal dissection or surgery for the treatment of early gastric cancer * Not willing to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year OS | From March 1 2019 to December 1 2024 | 5-year OS is the five year overall survival of each individual group. It will be estimated by Kaplan-Meier method, and statistical significance of differences between the two groups will be assessed using the log-rank test. |
| 5-year DSS | From March 1 2019 to December 1 2024 | 5-year DSS is the five year disease specific survival of each individual group. It will be estimated by Kaplan-Meier method, and statistical significance of differences between the two groups will be assessed using the log-rank test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication | From March 1 2019 to December 1 2024 | Complications were classified according to the Clavien-Dindo classification and the frequency of the complications will be compared between the two groups. |
Countries
China
Contacts
Primary ContactShigang Ding, MD
Outcome results
None listed