Early Gastric Cancer
Conditions
Brief summary
The goal of this retrospective observational cohort study is to describe the real-world clinicopathological characteristics, evolving treatment patterns, and long-term oncological outcomes of early gastric cancer (EGC) patients in China, utilizing a large prospective clinical database. The main questions it aims to answer are: How do different treatment modalities, including endoscopic resection, laparoscopic surgery, open surgery, and combined laparoscopic-endoscopic approaches, influence the long-term survival (Overall Survival and Disease-Free Survival) and recurrence patterns in Chinese EGC patients? What are the key clinicopathological factors affecting prognosis in this population? This study will retrospectively enroll approximately 5000 patients with histopathologically confirmed gastric adenocarcinoma staged as early gastric cancer (per AJCC 8th edition) from the information database of the National Clinical Research Center for Digestive Diseases. Researchers will systematically collect baseline demographics, treatment details, surgical complications, pathological staging, and longitudinal follow-up data (up to 10 years post-surgery) for all eligible patients. By comparing the short-term safety profiles and long-term survival benefits across different treatment groups and identifying risk factors for recurrence, this study aims to provide high-quality, China-specific evidence to guide standardized and individualized clinical decision-making for early gastric cancer.
Interventions
Retrospective collection of clinicopathological characteristics, treatment details, and long-term follow-up data from electronic medical records and the institutional database.
Sponsors
Beijing Friendship Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* patients aged between 18 and 90 years; * preoperative endoscopic biopsy-confirmed gastric adenocarcinoma; * clinical stage early gastric (cT1NxM0) cancer according to the AJCC 8th edition TNM staging system; * patients who have signed a broad informed consent. * Received primary treatment (including endoscopic resection, laparoscopic surgery, open surgery, or combined laparoscopic-endoscopic approach) at Beijing Friendship Hospital.
Exclusion criteria
* pregnant or breastfeeding women; * Preoperative or intraoperative diagnosis remained indeterminate due to insufficient pathological or imaging evidence, such that the patient could not be clearly classified as early gastric cancer prior to treatment; * Critical clinical data were severely incomplete or missing； * Completely lost to follow-up with no available information to confirm survival status.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival | From date of surgery to up to 10 years post-surgery | Disease-free survival is defined as the time from the date of surgery to the date of first documented tumor recurrence, metastasis, or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of surgery to up to 10 years post-surgery | Overall survival is defined as the time from the date of surgery to death from any cause. |
| Recurrence-Free Survival | From the date of surgery to 10 years post-surgery | Recurrence-free survival is defined as the time from the date of surgery to the first occurrence of disease recurrence. |
| Progression-Free Survival | From the date of surgery to 10 years post-surgery | Progression-free survival is defined as the time from the date of surgery to the first occurrence of either disease progression or death from any cause. Disease progression includes recurrence, metastasis, or progression of residual disease. |
| 30-Day Postoperative Complications | From the date of surgery to 30 days post-surgery | Incidence and severity of complications occurring within 30 days following surgery, graded according to the Clavien-Dindo classification. |
| 30-Day Postoperative Mortality | From the date of surgery to 30 days post-surgery | All-cause mortality occurring within 30 days after surgery, ascertained from medical records and follow-up data. |
| Unscheduled Second Surgery Rate | From the date of surgery to 30 days post-surgery | Rate of unscheduled reoperation within 30 days after the initial surgery, identified from surgical records and inpatient documentation. |
| Unplanned Return to Hospital Rate | From the date of surgery to 30 days post-surgery | Rate of unplanned hospital readmission within 30 days after discharge following the initial surgery, identified from readmission records. |
| Operation Time | At the time of surgery | Total duration of the surgical procedure, extracted from operative records. |
| Intraoperative Blood Loss | At the time of surgery | Estimated total volume of blood loss during the surgical procedure, extracted from operative records and anesthesia documentation. |
| Postoperative Length of Stay | From date of surgery until date of hospital discharge, assessed up to 2 weeks | Total number of days from the date of surgery to hospital discharge, extracted from inpatient medical records. |
| Preoperative Endoscopic Tumor Size | From 30 days prior to surgery to the date of surgery | Maximum diameter of the primary tumor (in millimeters) measured by preoperative gastroscopy. |
| Preoperative Endoscopic Macroscopic Type | From 30 days prior to surgery to the date of surgery | Macroscopic type of the primary tumor assessed by preoperative gastroscopy, classified as elevated (0-I), flat (0-IIa, IIb, IIc), or depressed (0-III) types according to the Paris classification. |
| Preoperative CT-Determined Tumor Invasion Depth (cT) | From 30 days prior to surgery to the date of surgery | Depth of tumor invasion assessed by preoperative contrast-enhanced CT, categorized as cT1, cT2, cT3, or cT4 according to the AJCC 8th edition TNM staging system. |
| Preoperative CT-Determined Lymph Node Status (cN) | From 30 days prior to surgery to the date of surgery | Lymph node metastasis status assessed by preoperative contrast-enhanced CT, categorized as cN0, cN1, cN2, or cN3 according to the AJCC 8th edition TNM staging system. |
| Preoperative CT Suspicious Lymph Node Count | From 30 days prior to surgery to the date of surgery | The number of suspicious metastatic lymph nodes identified during the preoperative enhanced CT examination. |
| Pathological Tumor Invasion Depth (pT) | From date of surgery to 7 days post-surgery | Pathological depth of tumor invasion assessed according to AJCC 8th edition pT category (pT1a, pT1b, pT2, pT3, or pT4) based on postoperative histopathological examination of the resected specimen. |
| Pathological Lymph Node Status (pN) | From date of surgery to 7 days post-surgery | Pathological lymph node metastasis status assessed according to AJCC 8th edition pN category (pN0, pN1, pN2, or pN3) based on postoperative histopathological examination. |
| Number of Lymph Nodes Examined | From date of surgery to 7 days post-surgery | Total number of lymph nodes retrieved and examined from the resected specimen. |
| Number of Positive Lymph Nodes | From date of surgery to 7 days post-surgery | Total number of lymph nodes with pathologically confirmed metastasis. |
| Anatomical Location of Metastatic Lymph Nodes | From date of surgery to 7 days post-surgery | Anatomical distribution of pathologically confirmed metastatic lymph nodes identified in the resected specimen, categorized by lymph node station (e.g., No.1, No.3, No.4sb, No.7, etc.) according to the Japanese Gastric Cancer Association (JGCA) classification system. Data will be extracted from postoperative pathology reports. |
| Lymph Node Metastasis Rate | From date of surgery to 7 days post-surgery | Proportion of positive lymph nodes among total lymph nodes examined (number of positive lymph nodes / total lymph nodes examined × 100%). |
| Histological Differentiation | From date of surgery to 7 days post-surgery | Histological differentiation of gastric adenocarcinoma, categorized as well-differentiated, moderately-differentiated, poorly-differentiated, or undifferentiated, based on postoperative pathology. |
| Lymphovascular Invasion | From date of surgery to 7 days post-surgery | Presence or absence of lymphatic and/or vascular invasion assessed by postoperative histopathological examination. |
| Perineural Invasion | From date of surgery to 7 days post-surgery | Presence or absence of perineural invasion assessed by postoperative histopathological examination. |
| R0 Resection Rate | From date of surgery to 7 days post-surgery | Proportion of patients with no residual tumor microscopically confirmed on both the primary tumor resection margins and resected lymph nodes, assessed by postoperative pathological examination. |
| Gastric Emptying Scintigraphy | From 30 days prior to surgery to 10 years post-surgery | It is evaluated by gastric emptying half-time (GET₁/₂) measured via radionuclide scintigraphy. |
| Helicobacter pylori Infection Status | From 30 days prior to surgery to 10 years post-surgery | Helicobacter pylori infection status determined by ¹³C/¹⁴C urea breath test. |
| EORTC QLQ-C30 | From 30 days prior to surgery to 10 years post-surgery | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC-QLQ-C30) includes 30 items measuring functional, symptomatic, and global quality-of-life domains. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life. |
| EORTC QLQ-STO22 | From 30 days prior to surgery to 10 years post-surgery | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Module 22(EORTC-QLQ-STO22) supplement contains 22 items assessing symptoms and concerns specific to gastric cancer. Scores are transformed to a 0-100 scale, with higher scores indicating greater symptom burden. |
| PGSAS-45 | From 30 days prior to surgery to 10 years post-surgery | The Postgastrectomy Syndrome Assessment Scale 45(PGSAS-45), consisting of 45 items, will be used to comprehensively evaluate postgastrectomy symptoms, digestive status, and daily life functions. All subscale scores are linearly transformed to a 0-100 range. For symptom-related subscales, higher scores indicate greater symptom burden; for functional and quality of life subscales, higher scores indicate better functioning or quality of life. |
| Serum Albumin | From 30 days prior to surgery to 10 years post-surgery | — |
| Serum Total Protein | From 30 days prior to surgery to 10 years post-surgery | — |
| Hemoglobin | From 30 days prior to surgery to 10 years post-surgery | — |
| Prognostic Nutritional Index (PNI) | From 30 days prior to surgery to 10 years post-surgery | It is a combined score based on serum albumin level and total lymphocyte count. It is calculated as 10 × serum albumin (g/dL) + 0.005 × total lymphocyte count (cells/μL). Higher scores indicate better nutritional and immunological status. |
| Inflammatory marker | From 30 days prior to surgery to 10 years post-surgery | It will be measured by serum C reactive protein (CRP) level. |
| Carcinoembryonic Antigen (CEA) | From 30 days prior to surgery to 10 years post-surgery | — |
| Carbohydrate Antigen 19-9 (CA19-9) | From 30 days prior to surgery to 10 years post-surgery | — |
| Carbohydrate Antigen 72-4 (CA72-4) | From 30 days prior to surgery to 10 years post-surgery | — |
| Alpha-Fetoprotein (AFP) | From 30 days prior to surgery to 10 years post-surgery | — |
| Carbohydrate Antigen 125 (CA125) | From 30 days prior to surgery to 10 years post-surgery | — |
| Time to First Flatus | From date of surgery until date of hospital discharge, assessed up to 2 weeks | Time from the date of surgery to the first passage of flatus, indicating recovery of gastrointestinal motility. Data will be extracted from postoperative recovery records. |
| Resumption of Oral Intake | From date of surgery until date of hospital discharge, assessed up to 2 weeks | Time from the date of surgery to the resumption of oral intake (liquid or solid diet), extracted from postoperative dietary records. |
| Overall Hospitalization Cost | From the time of admission to the time of discharge, assessed up to 3 weeks | — |
Countries
China
Contacts
CONTACTZhi Zheng, Attending surgon
Outcome results
None listed