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New treatment option for Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy
Official title Application of a New Surgical Technique in Proximal Gastrectomy: a Prospective, Multicenter Randomized Controlled Study
ClinicalTrials.gov ID: NCT06679244
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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...
- Expected survival exceeds 6 months;
You likely can't join if
- 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;
See the full eligibility 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...
- 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...
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.