NCT05539105 A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy
| NCT ID | NCT05539105 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Proximal Gastric Adenocarcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2022-08-22 |
| Primary Completion | 2027-12-31 |
Trial Parameters
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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.
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: \-