Status:
NOT_YET_RECRUITING
Clinical Trial of Reconstruction After Proximal Gastrectomy
Lead Sponsor:
Oncogastroenterology Committee of Chinese
Collaborating Sponsors:
Tang-Du Hospital
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Esophagitis, Reflux
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
1\) To explore a simple, safe, post-proximal gastrectomy reconstruction method with good absorption and digestive function in order to improve patients' postoperative quality of life; 2) To fill the g...
Detailed Description
Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related deaths each year. Although the incidence of gastric cancer has decreased worldwide compared to th...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients aged 18-80 years, regardless of gender;
- Siewert III of the esophagogastric junction adenocarcinoma: Stage Ⅰ(cT1-2N0M0) or adenocarcinoma of the upper part of the stomach： Stage Ⅰ(cT1-2N0M0), Stage II( cT1-2N1-3M0 / cT3-4N0M0), Stage III(cT3-4aN1-3M0); patients who are suitable for surgery according to the 8th AJCC clinical staging of gastric cancer;
- Primary lesion diagnosed by preoperative endoscopic end pathology: tumor diameter \<4 cm and located in the upper part of the stomach (including the esophagogastric junction), histologically confirmed adenocarcinoma;
- Preoperative ASA score: I, II, or III;
- Preoperative Karnofsky physical status score: ≥ 70%; or preoperative ECOG physical status score: ≤ 2;
- No distant metastases (confirmed by preoperative chest X-ray, abdominal ultrasound, and upper abdominal CT); no peritoneal implant metastases (confirmed by laparoscopic exploration surgery);
- R0 surgical outcome is expected to be obtained with radical gastrectomy of D2 proximal gastric cancer;
- Patients and their families voluntarily participate in this study and sign the informed consent form after understanding the study content.
- Exclusion Criteria
- Patients received any preoperative treatment, such as chemotherapy, radiotherapy, targeted therapy or immunotherapy; preoperative neoadjuvant chemotherapy recipients;
- Patients with clinical stage exceeding Siewert III of the esophagogastric junction adenocarcinoma: Stage Ⅰ(cT1-2N0M0) or more than adenocarcinoma of the upper part of the stomach: Stage Ⅰ(cT1-2N0M0), Stage II(cT1-2N1-3M0/cT3-4N0M0), Stage III(cT3-4aN1-3M0);
- Patients with acute infections, especially biliary tract infections;
- Patients with complications of gastric cancer (bleeding, perforation, obstruction) requiring emergency surgery;
- Patients with uncorrectable coagulation dysfunction;
- Patients with vital organ failure, such as heart, lung, liver, brain, kidney, etc.
- Severe central nervous system disease, mental disorders, or impaired consciousness;
- Pregnant or lactating women;
- Patients with distant metastases;
- Patients with a primary tumor at another site diagnosed within the past 5 years;
- Preoperative ASA score: ≥ IV;
- Preoperative ECOG physical status score: ≥ 2;
- History of continuous systemic corticosteroid therapy within the past 1 month;
- History of unstable angina, myocardial infarction, cerebral infarction, or cerebral hemorrhage within the past 6 months;
- Patients with concurrent surgical treatment of other diseases;
- Patients with immunodeficiency, immunosuppression, or autoimmune diseases (organ transplant requiring immunosuppressive therapy within the past 5 years, allogeneic bone marrow transplant patients, taking immunosuppressive drugs, etc.);
- Patients with concurrent participation in other clinical studies;
- Patients refusing to sign an informed consent form to participate in this study;
- Preoperative imaging: regional fusion of enlarged lymph nodes (maximal diameter \> 3 cm).
Exclusion
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05418920
Start Date
August 1 2022
End Date
July 31 2027
Last Update
July 5 2022
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