Gastric cancer
Conditions
Interventions
SIS Anastomotic Reinforcement Patch Group:using the SIS Anastomotic Reinforcement Patch
Sponsors
Beijing Tsinghua Changgung Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients must meet all of the following criteria to be enrolled in this trial: (1) Aged 18 to 75 years, inclusive, regardless of sex; (2) Preoperatively diagnosed with gastric cancer via gastroscopy and biopsy, and scheduled to undergo radical gastrectomy + lymph node dissection + digestive tract reconstruction; (3) Determined by the investigator to have >=2 high-risk factors for anastomotic leakage (neoadjuvant therapy, long-term use of corticosteroids or immunosuppressants, severe diabetes, pyloric obstruction caused by the tumor, etc.).
Exclusion criteria
Exclusion criteria: 1.Patients meeting any of the following exclusion criteria will not be enrolled in this trial: (1) History of prior abdominal surgery (except cholecystectomy); (2) Presence of other concurrent malignant tumors; (3) Preoperative tumor assessment indicates invasion of adjacent organs or presence of distant metastasis; (4) Coagulation dysfunction ( 1). prothrombin time (PT) > 18 seconds or exceeding 1.5 times the upper limit of the normal reference range with clinically significant abnormality, or 2). activated partial thromboplastin time (APTT) > 60 seconds or exceeding 1.5 times the upper limit of the normal reference range with clinically significant abnormality); (5) Use of platelet receptor antagonists within 48 hours prior to surgery; (6) Inability to receive porcine-derived devices due to religious, ethnic, or other reasons; (7) Expected survival < 6 months; (8) Pregnancy or breastfeeding, or planned pregnancy during the trial period; (9) Participation in a drug clinical trial within the past 3 months or ongoing participation, or participation in another medical device clinical trial within the past 30 days or ongoing participation; (10) Inability to understand the protocol due to language or intellectual impairment, or inability to complete follow-up during the trial period; (11) Other reasons deemed by the investigator as making the patient unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anastomotic leakage rate within 30 days post-surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative complication indicators(severity classification and incidence of anastomotic leakage, incidence of anastomotic bleeding, incidence of anastomotic stenosis);Postoperative intestinal function index;Postoperative drainage index;Indicators of postoperative complications (incidence of abdominal and pelvic infection, abscess, sepsis, abdominal bleeding, intestinal obstruction); | — |
Countries
China
Contacts
Public ContactGuoxin Li
Beijing Tsinghua Changgung Hospital
Outcome results
None listed