RecruitingNCT05539105
A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy
Sponsor
Shanghai Zhongshan Hospital
Enrollment
600 participants
Start Date
Aug 22, 2022
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria8
- 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 Criteria1
- \-
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Interventions
PROCEDUREDouble tract reconstruction
Double tract reconstruction would be applied after radical proximal gastrectomy.
PROCEDUREGastric conduit reconstruction
Gastric conduit reconstructionn would be applied after radical proximal gastrectomy.
PROCEDUREOther reconstructions
Other reconstructions except for double tract and gastric conduit reconstructions would be applied after radical proximal gastrectomy.
Locations(1)
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NCT05539105