Surgical technique for gastric cancer reconstruction
Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy，Phase II Trial
This study is testing a new surgical technique for patients with early-stage gastric cancer to see if it can improve their recovery and results after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06354036 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on patients with early-stage gastric cancer who will undergo laparoscopic proximal gastrectomy. The study employs the Transhiatal Tunnel Valvuloplasty technique for esophagogastric anastomosis, aiming to improve surgical outcomes. Key metrics such as surgical time, bleeding volume, and anastomosis time will be recorded to evaluate the effectiveness of the procedure. The trial seeks to provide a detailed assessment of this innovative surgical approach.
Who should consider this trial
Good fit: Ideal candidates are patients with early adenocarcinoma of the upper stomach or esophagogastric junction, with tumors less than 4 cm and no distant metastasis.
Not a fit: Patients undergoing preoperative chemotherapy or those with severe cardiovascular and pulmonary diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could enhance recovery and outcomes for patients undergoing surgery for gastric cancer.
How similar studies have performed: While this approach is innovative, similar surgical techniques have shown promise in improving outcomes in gastric cancer surgeries.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Confirmed by gastroscopy pathological biopsy and imaging examination as early adenocarcinoma of the upper part of the stomach or adenocarcinoma of the esophageal gastric junction; 2. Tumor diameter\<4cm, with no distant metastasis; 3. Clinical staging T1-3N0-1M0; 4. On the basis of proximal gastrectomy, 50% of the gastric volume can still be retained; 5. ECOG-PS status score 0-1 points (Eastern Cooperative Oncology Group). Exclusion Criteria: 1. Patients undergoing preoperative neoadjuvant chemotherapy; 2. Patients with severe cardiovascular and pulmonary diseases who cannot tolerate laparoscopic surgery; 3. Incomplete clinical data.
Where this trial is running
Beijing
- Department of Pancreatic and Gastric Surgical Oncology, National Cancer Center/ National Clinical Research for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Dongbing Zhao
- Email: dbzhao@cicams.ac.cn
- Phone: 87787121
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.