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NCT Number: NCT06679244

Application of a New Surgical Technique in Proximal Gastrectomy: a Prospective, Multicenter Randomized Controlled Study

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old ≤ 80 years old;
  • The primary tumor lesion is located in the upper part of the stomach or the esophagogastric junction (Siewert II or III), and it is expected that R0 surgical results can be obtained by performing proximal gastrectomy and D2 dissection;
  • The primary lesion was diagnosed as adenocarcinoma through endoscopic biopsy and histopathological examination;
  • If it is upper gastric adenocarcinoma, the clinical TNM staging based on imaging needs to be cT1N0M0. If it is ductal gastric junction adenocarcinoma, it needs to be cT1-3N0-1M0, and clinical imaging judgment shows no distant gastric lymph node metastasis;
  • Expected survival exceeds 6 months;
  • No history of upper abdominal surgery (excluding laparoscopic cholecystectomy);
  • No chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. were performed before surgery;
  • Preoperative ECOG (Eastern Cooperative Oncology Group) physical status score 0/1;
  • Preoperative ASA (American Society of Anesthesiologists) grading I-III ;
  • Good function of important organs;
  • Sign the patient's informed consent form

Exclusion criteria

  • Preoperative imaging examination suggests the fusion of enlarged lymph nodes (maximum diameter ≥ 3cm) in the area;
  • Pregnant and lactating women;
  • Suffering from other malignant tumors within 5 years;
  • Preoperative body temperature ≥ 38 ℃ or complicated with infectious diseases requiring systematic treatment;
  • Serious mental illness;
  • Severe respiratory diseases, FEV1<50% of the expected value;
  • Severe liver and kidney dysfunction;
  • History of unstable angina or heart attack within 6 months;
  • History of cerebral infarction or cerebral hemorrhage within 6 months, excluding old intracavitary infarction;
  • Apply systemic corticosteroid therapy within one month;
  • Patients with complications of gastric cancer (bleeding, perforation, obstruction) requiring emergency surgery;
  • The patient has participated or is currently participating in other clinical studies (within 6 months)

Treatment and study plan

Totally laparoscopic proximal gastrectomy with Hao's esophagogastrostomy by fissure technique

Procedure

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

Totally laparoscopic proximal gastrectomy with double-tract reconstruction

Procedure

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.

Primary outcomes

  1. body weight loss(BWL)

    Time frame: From enrollment to 1 year after surgery

    Measure the weight before surgery and 1 year after surgery, BWL=(preoperative weight -1 year after surgery weight)/preoperative weight (unit:%)

Secondary outcomes

  1. Hemoglobin 1 year after surgery

    Time frame: 1 year after surgery

    Hemoglobin (unit: g/L) 1 year after surgery will be used to evaluate operation effect.

  2. Serum albumin 1 year after surgery

    Time frame: 1 year after surgery

    Serum albumin (unit: g/L) 1 year after surgery will be used to evaluate operation effect.

  3. Incidence of anastomotic stenosis 1 year after surgery

    Time frame: 1 year after surgery

    Incidence of anastomotic stenosis(%) 1 year after surgery will be used to evaluate operation effect.

  4. Incidence of reflux esophagitis 1 year after surgery

    Time frame: 1 year after surgery

    Incidence of reflux esophagitis 1 year after surgery will be used to evaluate operation effect.

  5. Duration of surgery

    Time frame: intraoperative

    Time spent on the whole operation(minutes)will be used to evaluate short-term safety of the surgery

  6. Intraoperative blood loss

    Time frame: Intraoperative

    Intraoperative blood loss(ml) will be used to evalute short-term safety of the surgery.

  7. Incidence of anastomotic leakage 7 days after surgery

    Time frame: 7 days after surgery

    Incidence of anastomotic leakage(%) 7 days after surgery will be used to evaluate short-term safety of the surgery

  8. Incidence of pancreatic leakage 7 days after surgery

    Time frame: 7 days after surgery

    Incidence of pancreatic leakage 7 days after surgery will be used to evaluate short-term safety of the surgery.

  9. Incidence of abdominal infection 7 days after surgery

    Time frame: 7 days after surgery

    Incidence of abdominal infection 7 days after surgery will be used to evaluate short-term safety of the surgery.

  10. Overall survival (OS) 3 years after surgery

    Time frame: 3 years after surgery

    Overall survival (OS, %) 3 years after surgery will be used to evaluate medium- and long-term postoperative safety

  11. Disease free survival (DFS) 3 years after surgery

    Time frame: 3 years after surgery

    Disease free survival (DFS, %) 3 years after surgery will be used to evaluate medium- and long-term postoperative safety,

Study contacts

Contact information is provided by the study sponsor or research team.

Hankun Hao, doctor

CONTACT

[email protected]

+86 18121186328

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Collaborators

  • Ruijin Hospital
  • Shanghai Cancer Hospital, China

Registry information

Official study title

Application of Hao's Esophagogastrostomy by Fissure Technique: a Prospective, Multicenter Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Nov 7, 2024
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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