Status:
UNKNOWN
Clinical Study on the Safety of Double and a Half Layered Esophagojejunal Anastomosis in Curative Gastrectomy
Lead Sponsor:
Henan Cancer Hospital
Collaborating Sponsors:
Luoyang Central Hospital
Nanyang Central Hospital
Conditions:
Surgery--Complications
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Surgical resection remain the main means for gastric cancer. With the improvement of surgical techniques and concepts, the incidence of postoperative complications gradually decreased, but esophagojej...
Detailed Description
Surgical resection remain the main means for gastric cancer. How to reconstruct the digestive tract after total gastrectomy for gastric cancer is a hot topic for clinicians. Compared to jejunojejunost...
Eligibility Criteria
Inclusion
- The patients voluntarily participated in the study and signed the informed consent
- 18 years old≤75 years old
- The primary gastric lesion was diagnosed as gastric adenocarcinoma by endoscopic biopsy
- Patients scheduled for radical gastrectomy with esophagojejunostomy (also applicable for multiple primary cancers)
- ECOG physical status score 0/1
- ASA score I-III
- The expected survival time is more than 12 weeks
- The patient agreed to accept the operation and signed the informed consent form to undertake the risk of the operation
Exclusion
- Other malignant tumors occurred or coexisted within 5 years
- History of upper abdominal surgery (except laparoscopic cholecystectomy)
- History of gastric surgery (except for patients who failed ESD/EMR for gastric cancer and needed radical gastrectomy and planned esophagojejunostomy)
- Pregnant or lactating women
- Have a history of psychotropic drug abuse and can not quit or have mental disorders
- Patients with severe cachexia, inability to eat or tolerate surgery
- Preoperative imaging examination showed that the tumor invaded the surrounding organs and regional fusion enlarged lymph nodes (maximum diameter≥3cm) and could not be radical resection
- A history of unstable angina or myocardial infarction within 6 months There was a history of cerebral infarction or cerebral hemorrhage within 6 months
- There was a history of continuous systemic corticosteroid therapy within 1 month
- Other diseases need to be treated by surgery at the same time
- Gastric cancer complications (bleeding, perforation, obstruction) need emergency surgery
- Pulmonary function test FEV1\<50% of predicted value
- Patients with any severe and/or uncontrolled disease include:
- Patients with hypertension who can not be well controlled by antihypertensive drugs (systolic blood pressure≥150 mmHg, diastolic blood pressure≥100 mmHg);
- Patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc≥480ms) and grade 2 or above congestive heart failure (NYHA classification);
- Active or uncontrolled severe infection (≥CTCAE grade 2 infection);
- Renal failure requires hemodialysis or peritoneal dialysis;
- History of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or organ transplantation;
- The patients with poor glycemic control (FBG\>10mmol/L);
- Patients with epilepsy and need treatment;
- According to the judgment of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05282563
Start Date
July 1 2021
End Date
June 1 2024
Last Update
March 16 2022
Active Locations (1)
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1
Henan cancer hopital
Zhengzhou, Henan, China, 450008