Adenocarcinoma of Esophagogastric Junction, Gastric Cancer
Conditions
Keywords
proximal gastrectomy, totally laparoscopic gastrectomy, fissure technique
Brief summary
This is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III). The study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22.
Interventions
PROCEDUREPerforming totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique
Surgical Operation: 1. Gastric Resection Range:Proximal gastrectomy, preserving 2/3 of the distal stomach. 2. Lymph Node Dissection Range:D1+ to D2 lymph node dissection. 3. Anastomosis Method: esophagogastrostomy by fissure technique. 4. Anastomosis Risk Management Plan:For a rupture with a maximum diameter less than or equal to 5mm, repair with 4-0/3-0 absorbable sutures and proceed with the anastomosis.For a rupture with a maximum diameter greater than 5mm or failed anastomosis, resect that part of the remaining stomach, change to proximal gastrectomy, and perform double-channel anastomosis. 5. Surgical Approach:Totally laparoscopic proximal gastrectomy.
Sponsors
Huashan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients included in this group will receive totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique，which is an innovative surgery that investigators first began to apply in patients with proximal gastric cancer.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 75 years old; 2. Pathologically confirmed as adenocarcinoma; 3. Primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (Siewert II or III); 4. If it is adenocarcinoma of the upper 1/3 of the stomach, cT1N0M0 should be met. 5. For gastroesophageal junction adenocarcinoma, cT1-2N0M0 should be met, and clinical judgment should indicate no distant lymph node metastasis around the stomach. 6. Bilateral resection margins should be greater than 2 cm, and more than half of the residual stomach should be preserved. 7. No history of upper abdominal surgery (excluding laparoscopic cholecystectomy). 8. No preoperative comprehensive treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. 9. Preoperative ECOG (Eastern Cooperative Oncology Group) score of 0/1. 10. Preoperative ASA (American Society of Anesthesiologists) score I-III. 11. Good function of important organs. 12. Signed informed consent.
Exclusion criteria
1. Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis; 2. Pregnant or lactating women; 3. Patients with severe mental illness; 4. Preoperative temperature ≥38°C or infectious diseases requiring systemic treatment; 5. Severe respiratory diseases, with FEV1 \< 50% of predicted value; 6. History of other malignant tumors in the past 5 years; 7. Severe liver or kidney dysfunction; 8. Unstable angina or myocardial infarction within the last 6 months; 9. History of stroke or cerebral hemorrhage within the last 6 months (excluding old infarcts); 10. Systemic use of glucocorticoids within the last 1 month; 11. Emergency surgery required due to complications of gastric cancer (bleeding, perforation, obstruction); 12. Patient has participated in or is currently participating in other clinical trials (within the last 6 months).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative TNM staging by Pathological findings . | 30 days after the surgery | AJCC（American Joint Committee on Cancer）-8th TNM staging system will be used to obtain pathology of tumor . |
| Assess intraoperative Perioperative Safety by Duration of surgery. | intraoperative | Time spent on the whole operation（minutes） |
| Assess intraoperative Perioperative Safety by Duration of anastomosis. | intraoperative | Time spent on the anastomosis in minutes |
| Assess intraoperative Perioperative Safety by blood loss . | intraoperative | Intraoperative blood loss in milliliters |
| Postoperative recovery course | 30 days after the surgery | Time to remove the drain tube,flatus, to liquid diet, and soft diet are used to assess the postoperative recovery course, which is a composite outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of postoperative anastomotic stenosis | 3 months after surgery | Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination |
| Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-C30 | 3 months after surgery | QLQ-C30 is a comprehensive assessment of the overall quality of life dimensions before and after surgery for patients. Higher scores represent poorer quality of life for patients after surgery. |
| Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-STO22 scale | 3 months after surgery | QLQ-STO22 is a specific assessment for postoperative situations related to anastomosis, such as swallowing and eating.Higher scores represent poorer quality of life for patients after surgery. |
| The incidence of postoperative reflux esophagitis | 3 months after surgery | Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination |
Countries
China
Outcome results
None listed