Early gastric cancer
Conditions
Interventions
None listed
Sponsors
Division of gastroenterology, Tohoku University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with primary early gastric cancers that are scheduled to undergo ESD (2) Patients with 0-2 in performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) criteria (3) Patients who agreed and turned in the written agreement for participation of this study
Exclusion criteria
Exclusion criteria: (1) Patients with a history of endoscopic resection for early gastric cancers (2) Patients with a history or a plan of gastrectomy (3) Patients with a history or a plan of chemotherapy for gastric cancers (4) Patients with a history or a plan of surgery, chemotherapy, or radiation therapy for esophageal cancers (5) Patients with a history of chemotherapy for malignant tumors excluding gastric or esophageal cancers within 5 years (6) Patients with malignant tumors except for gastric or esophageal cancers who have a plan for endocrine therapy, chemotherapy, or radiation at the time of enrollment (7) Patients with early gastric cancers which did not meet the curative resection for ESD in the guidelines (8) Patients with gastric lesions diagnosed as Group 4 in the preoperative diagnosis resulting as no cancer in the pathological diagnosis of ESD specimen (9) Patients with pregnancy or breast-feeding (10) Patients with severe psychiatric disease (11) Patients regard as inappropriate for enrollment by the researcher (12) Patients whose serum creatinine level are 2.0 mg/dL or more (13) Patients who cannot understand Japanese language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 5-year cumulative incidence rate of metachronous gastric cancers according to smoking in Helicobacter pylori (H. pylori)-eradicated patients who underwent ESD for early gastric cancers | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The association between the incidence of metachronous gastric cancer (MGC) and smoking, drinking, body mass index, diabetes mellitus, preferences for salty taste, intake of green vegetables, intake of green tea, gastric atrophy diagnosed by endoscopy, and pepsinogen (PG) level before eradication of H. pylori 2) The association between the incidence of MGC and the detailed information of smoking 3) The establishment of cut-off value of PG level after H. pylori eradication for predicting the incidence of MGC 4) The comparison of cumulative incidence rate of MGC between H. pylori-eradicated cases and H. pylori-negative cases (those who never underwent H. pylori eradication) 5) The association between incidence of MGC and PG level before eradication of H. pylori 6) The association between incidence of MGC and change rate of PG level before and after eradication of H. pylori 7) The association between incidence of synchronous gastric cancer and factors related to life-style, H. pylori, and PG level 8) The incidence rate of esophageal cancer and factors associated with the incidence of esophageal cancer in patients who underwent ESD for early gastric cancer 9) The cumulative incidence rate of MGC and factors associated with the incidence of MGC in patients who underwent ESD for primary early gastric cancer that occurred in H. pylori-eradicated patients 10) The location of MGC 11) The association between incidence of synchronous gastric cancer and ALDH2-genotype, ADH1B-genotype, or the alcohol intake 12) The association between incidence of MGC and ALDH2-genotype, ADH1B-genotype, the alcohol intake, or cessation of drinking 13) The association between incidence of esophageal cancer in patients who underwent ESD for early gastric cancer and ALDH2-genotype, ADH1B-genotype, the alcohol intake, or cessation of drinking | — |
Countries
Japan
Contacts
Public ContactWaku Hatta
Tohoku University Graduate School of Medicine Division of Gastroenterology
Outcome results
None listed