Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT05545293
Eligibility Criteria:
Inclusion Criteria:
* Age from 18 to years (including 18 and 85years old)
* Pathological diagnosis of primary focus is gastric adenocarcinoma made by endoscopic biopsy (papillary, tubular, mucinous, signet ring cell, poorly differentiated)
* cT1-4a, N+/-, M0 at preoperative evaluation
* No peritoneal metastasis or other distant metastases of gastric carcinoma (affirmed by laparoscopic surgery and related imaging examinations)
* Expected curative resection through laparoscopic distal gastrectomy with D2 lymphadenectomy (include multiple primary lower gastric adenocarcinoma)
* Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
* Preoperative American Society of Anesthesiology score (ASA) classⅠ, Ⅱ or Ⅲ
* Major organs are functioning normally:
blood routine test (No blood transfusions in the last 14 days): HB≥90g/L, ANC≥1.5×109/L, PLT≥80×109/L blood biochemical examination: BIL\<1.5× upper limit of normal (ULN), ALT and AST\<2.5×ULN, Crea≤1×ULN.
\- The subject is willing to participate in this clinical trail
Exclusion Criteria:
* History of previous upper abdominal surgery (include ESD/EMR, except laparoscopic cholecystectomy)
* History of acute pancreatitis
* Regional fusion of enlarged lymph nodes by preoperative imaging (maximum diameter \>3cm)
* History of other malignant disease within past five years
* History of unstable angina, myocardial infarction, cerebral infraction, or cerebral hemorrhage within past six months
* History of continuous systematic corticosteroids therapy within past one month
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, or perforation) caused by gastric cancer
* FEV1\<50% of predicted values by pulmonary function test
* Women during pregnancy or breast-feeding
* Severe mental disorder
* Participating in other clinical studies simultaneously
* Refusing to sign the informed consent for the study
* Peritoneal implant or other distant metastases by intraoperative exploration
* Unresectable due to tumor reasons by intraoperative exploration
* Distal gastric cancer surgery cannot be performed after intraoperative exploration
* Duodenal bulb has been invaded by tumor or gastroduodenostomy cannot be performed due to additional surgical resection cause by positive intraoperative frozen margin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05545293
Study Brief:
Protocol Section:
NCT05545293