An interventional study of Totally laparoscopic proximal gastrectomy with Hao's esophagogastrostomy by fissure technique and Totally laparoscopic proximal gastrectomy with double-tract reconstruction in Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy, sponsored by Huashan Hospital. Recruiting at 3 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by Huashan Hospital · Not applicable, Interventional, and Treatment
This is a prospective study using a multicenter, randomized, controlled, open label, and efficacy validated approach.At present, there is no universally recognized optimal method for gastrointestinal reconstruction after proximal gastrectomy in the surgical treatment of gastric cancer.Author's team has proposed an innovative method named Hao's Esophagogastrostomay by Fisture Technique (HEFT).By adding anti reflux structures such as "false gastric fundus" and "false cardia" to the anastomosis of the residual stomach of the esophagus, not only can the purpose of anti reflux be achieved, but also the normal physiological channel can be maintained, it can fully utilize residual stomach function and reduce the difficulty of surgery.Through retrospective research, our single center has confirmed that HEFT is safe and feasible.On this basis, this study will compare the nutritional status, short- and medium- to long-term safety after laparoscopic HEFT and double-tract reconstruction , in order to evaluate and discover more reasonable digestive tract reconstruction methods after proximal gastrectomy, and to promote the development and popularization of minimally treatment technology for gastric cancer.
This study was jointly conducted by Shanghai-level hospitals (Huashan Hospital ,Shanghai Cancer Center, and Ruijin Hospital), with Huashan Hospital as the leading unit. This study will recruit 52 patients, with 26 patients in the experimental group and 26 patients in the control group. Using a central dynamic randomization method based on minimization, patients are assigned to groups in a 1:1 ratio. Based on the different anastomotic methods used in proximal gastrectomy, patients are divided into a HEFT group (experimental group) and a double-tract reconstruction group (control group).Plan to collect cases for 2 years, and follow up for another year after the last case is enrolled.
The primary endpoint of the study was the body weight loss (BWL) rate at 1 year after surgery. Secondary endpoints: Effect evaluation indicators: hemoglobin level at 1 year after surgery; Serum albumin level at 1 year after surgery; The incidence of anastomotic stenosis 1 year after surgery; Incidence of reflux esophagitis at 1 year after surgery. Evaluation of short-term surgical safety (duration: 7 days): operation time, intraoperative bleeding, anastomotic leakage, pancreatic leakage, and incidence of abdominal infection; Evaluation of medium- and long-term safety after surgery (duration: 36 months): overall survival rate at 3 years after surgery; disease-free survival rate at 3 years after surgery.
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Exclusion Criteria:
Procedure: Totally laparoscopic proximal gastrectomy with Hao's esophagogastrostomy by fissure technique
Procedure: Totally laparoscopic proximal gastrectomy with double-tract reconstruction
This is an innovative surgical method applied in proximal gastrectomy. By adding anti reflux structures such as "false gastric fundus" and "false cardia" on the basis of esophageal residual gastric anastomosis, the goal of anti reflux is achieved, while maintaining normal physiological channels and fully utilizing residual gastric function, reducing the difficulty of proximal gastrectomy surgery
This is a traditional surgical method that has been widely used in proximal gastrectomy. After disconnecting the proximal stomach, performing Roux-en-Y anastomosis of the esophagus and jejunum firstly, followed by lateral anastomosis of the residual stomach and jejunum. Previous studies have confirmed its safety and effectiveness, but there are also issues of gastric channel disuse and high missed detection rate of residual stomach.
body weight loss（BWL）
Measure the weight before surgery and 1 year after surgery, BWL=(preoperative weight -1 year after surgery weight)/preoperative weight (unit:%)
Time frame: From enrollment to 1 year after surgery
Hemoglobin 1 year after surgery
Hemoglobin (unit: g/L) 1 year after surgery will be used to evaluate operation effect.
Time frame: 1 year after surgery
Serum albumin 1 year after surgery
Serum albumin (unit: g/L) 1 year after surgery will be used to evaluate operation effect.
Time frame: 1 year after surgery
Incidence of anastomotic stenosis 1 year after surgery
Incidence of anastomotic stenosis(%) 1 year after surgery will be used to evaluate operation effect.
Time frame: 1 year after surgery
Incidence of reflux esophagitis 1 year after surgery
Incidence of reflux esophagitis 1 year after surgery will be used to evaluate operation effect.
Time frame: 1 year after surgery
Duration of surgery
Time spent on the whole operation（minutes）will be used to evaluate short-term safety of the surgery
Time frame: intraoperative
Intraoperative blood loss
Intraoperative blood loss(ml) will be used to evalute short-term safety of the surgery.
Time frame: Intraoperative
Incidence of anastomotic leakage 7 days after surgery
Incidence of anastomotic leakage(%) 7 days after surgery will be used to evaluate short-term safety of the surgery
Time frame: 7 days after surgery
Incidence of pancreatic leakage 7 days after surgery
Incidence of pancreatic leakage 7 days after surgery will be used to evaluate short-term safety of the surgery.
Time frame: 7 days after surgery
Incidence of abdominal infection 7 days after surgery
Incidence of abdominal infection 7 days after surgery will be used to evaluate short-term safety of the surgery.
Time frame: 7 days after surgery
Overall survival (OS) 3 years after surgery
Overall survival (OS, %) 3 years after surgery will be used to evaluate medium- and long-term postoperative safety
Time frame: 3 years after surgery
Disease free survival (DFS) 3 years after surgery
Disease free survival (DFS, %) 3 years after surgery will be used to evaluate medium- and long-term postoperative safety,
Time frame: 3 years after surgery
Plan to share: No
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