Observational registry on reconstruction methods after stomach surgery
A Prospective Observation Registry Study on the Alimentary Reconstruction After Radical Proximal Gastrectomy
Shanghai Zhongshan Hospital · NCT05539105
This study looks at different ways to rebuild the stomach after surgery for cancer to see which method helps patients recover better and feel good.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05539105 on ClinicalTrials.gov |
What this trial studies
This observational registry study aims to compare the safety and efficacy of various reconstruction methods following radical proximal gastrectomy for patients diagnosed with proximal gastric adenocarcinoma. Eligible participants, aged 18 to 80, will undergo a thorough preoperative assessment to ensure they meet specific health criteria. The study will track outcomes related to different surgical techniques, including double tract and gastric conduit reconstructions, to determine the best approach for patient recovery and quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with upper gastric adenocarcinoma eligible for radical proximal gastrectomy.
Not a fit: Patients with advanced disease or significant comorbidities that prevent safe surgical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective reconstruction methods, improving recovery and outcomes for patients undergoing surgery for gastric cancer.
How similar studies have performed: While similar observational studies have been conducted, this specific comparison of reconstruction methods is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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: \-
Where this trial is running
Shanghai, Shanghai Municipality
- Zhongshan Hospital Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Proximal Gastric Adenocarcinoma, Reconstruction, Proximal gastrectomy