Actively Recruiting
Application of a New Surgical Technique in Proximal Gastrectomy: a Prospective, Multicenter Randomized Controlled Study
Led by Huashan Hospital · Updated on 2025-07-22
52
Participants Needed
3
Research Sites
234 weeks
Total Duration
On this page
Sponsors
H
Huashan Hospital
Lead Sponsor
R
Ruijin Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Application of a New Surgical Technique in Proximal Gastrectomy: a Prospective, Multicenter Randomized Controlled Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Primary tumor located in upper stomach or esophagogastric junction (Siewert II or III) with expected R0 resection by proximal gastrectomy and D2 dissection
- Diagnosis of adenocarcinoma confirmed by biopsy and histopathology
- Clinical staging: for upper gastric adenocarcinoma cT1N0M0; for esophagogastric junction adenocarcinoma cT1-3N0-1M0 with no distant lymph node metastasis
- Expected survival longer than 6 months
- No prior upper abdominal surgery except laparoscopic cholecystectomy
- No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy before surgery
- ECOG performance status 0 or 1 before surgery
- ASA physical status classification I to III before surgery
- Good function of major organs
- Signed informed consent form
You will not qualify if you...
- Enlarged lymph nodes fused with diameter ≥3 cm on preoperative imaging
- Pregnant or breastfeeding women
- History of other malignant tumors within past 5 years
- Preoperative fever ≥38°C or active infectious diseases needing treatment
- Serious mental illness
- Severe respiratory disease with FEV1 less than 50% of expected
- Severe liver or kidney dysfunction
- Unstable angina or heart attack within past 6 months
- Stroke or cerebral hemorrhage within past 6 months, excluding old infarction
- Use of systemic corticosteroids within one month
- Complications of gastric cancer requiring emergency surgery (bleeding, perforation, obstruction)
- Participation in other clinical trials within past 6 months
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200025
Actively Recruiting
2
Huashan Hospital, Fudan University
Shanghai, China
Actively Recruiting
3
Second Department of Gastric Surgery, Fudan University Shanghai Cancer Center,
Shanghai, China
Actively Recruiting
Research Team
H
Hankun Hao, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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