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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGAssess intraoperative Perioperative Safety by Duration of surgery.
Time spent on the whole operation(minutes)
Time frame: intraoperative
Assess intraoperative Perioperative Safety by Duration of anastomosis.
Time spent on the anastomosis in minutes
Time frame: intraoperative
Assess intraoperative Perioperative Safety by blood loss .
Intraoperative blood loss in milliliters
Time frame: intraoperative
Postoperative recovery course
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.
Time frame: 30 days after the surgery
Postoperative TNM staging by Pathological findings .
AJCC(American Joint Committee on Cancer)-8th TNM staging system will be used to obtain pathology of tumor .
Time frame: 30 days after the surgery
The incidence of postoperative reflux esophagitis
Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination
Time frame: 3 months after surgery
The incidence of postoperative anastomotic stenosis
Patients will be monitored for the incidence of postoperative reflux esophagitis after surgery by weight changes, blood biochemistry and endoscopic examination
Time frame: 3 months after surgery
Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-C30
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.
Time frame: 3 months after surgery
Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-STO22 scale
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.
Time frame: 3 months after surgery
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