A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Proximal Gastric Adenocarcinoma
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Reflux esophagitis incidence 1 year after surgery
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This study is designed as a prospective, real world registry study that compare the safety and efficacy of the different construction methods after radical proximal gastrectomy.
Detailed Description
* The patient was admitted to the hospital, and at the time of physical examination, the following conditions were met: 18 years old ≤ age ≤ 80 years old; preoperative ECOG performance status score 0/1; non-pregnant or lactating women; no serious mental illness; no serious respiratory disease; No severe hepatic and renal insufficiency; no history of unstable angina pectoris and myocardial infarction within 6 months; no history of cerebral infarction or cerebral hemorrhage within 6 months, except for old cavity infarction; no history of continuous glucocorticoid therapy (local Except for applications); pulmonary function test showed FEV1 ≥ 50% of the predicted value. The patient did not participate in other clinical studies (within 6 months). * gastric adenocarcinoma was diagnosed by endoscopic examination and histopathological biopsy of the patient's primary lesion, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly adherent carcinoma (including signet ring cell carcinoma and other types), Mixed adenocarcinoma, etc. In qualified units, endoscopic ultrasonography (EUS) is recommended. The tumor is located in the upper part of the stomach or at the esophagogastric junction (tumor diameter is less than 4cm, and the length of invasion of the esophagus is less than 2cm); * Enhanced CT scan of the abdomen and pelvis was performed on the patient. For upper gastric cancer, no tumor invading the muscular layer, subserosal layer or serosa layer was found, and no distant metastasis occurred; for esophagogastric junction cancer, no distant metastasis occurred; * The patient has a clear diagnosis of gastric adenocarcinoma, and it is expected that proximal gastrectomy and lymph node dissection can be performed to obtain an R0 surgical result. . * The patient's ASA is I-III. ⑥ At this point, the patient becomes a potential selected case and enters the case selection procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 18-80 years
- •Tumor located in the upper or esophagogastric junction (EGJ), and curative resection with more than 1/2 remant is expected to be achievable by proximal gastrectomy with D2 lymphadenectomy (also apply to multiple primary cancers);
- •Clinical stage T1NxM0 (According to AJCC-8th TNM staging system) of the upper stomach or diameter of EGJ cancer less than 4cm with invading esophgus no more than 2cm without any distant metastasis;
- •Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
- •Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1
- •Preoperative ASA (American Society of Anesthesiologists) scoring: I-III
- •Sufficient organ functions
- •Written informed consent
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Reflux esophagitis incidence 1 year after surgery
Time Frame: 1 year
Reflux esophagitis refers to esophageal erosions and/or esophageal ulcers caused by the reflux of esophageal contents into the esophagus or above (oral mouth, throat, lungs) causing complaints of discomfort and endoscopic manifestations of esophageal mucosal defects.
Secondary Outcomes
- Morbidity after surgery(30 days)
- Body weight(kg) after surgery(12 months)
- Albumin(g/L) after surgery(12 months)
- Hemoglobin(g/L) after surgery(12 months)
- 3-year relapse free survival rate(3 years)
- Mortality after surgery(30 days)