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:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT04227951
Eligibility Criteria:
Inclusion Criteria:
* all consecutive patients that undergo total or subtotal gastrectomy with a curative intent, for histologically proven gastric cancer or esophago-gastric junction cancer Siewert type II or III, in surgical investigator centres from the beginning of the study until reaching the accrual number
* esophageal involvement \<= 2 cm
* patients undergoing upfront surgery or treated with a neoadjuvant/perioperative chemotherapy
* open, hybrid, laparoscopic or robotic approach
* all types of anastomosis (circular stapled, linear stapled, hand sewn)
Exclusion Criteria:
* refuse to sign informed consent
* age \<18
* Heart failure New York Heart Association (NYHA) class IV
* severe liver disease (Child \>= 7)
* pregnancy
* metastatic disease
* emergency surgery
* palliative surgery
* operation different from total or subtotal oncological gastrectomies (e.g. pylorus preserving, proximal gastrectomy)
* lymphnodal dissection \<D1
* reconstruction different from Roux-en-Y or Billroth II
* multiple organ resections (except for cholecystectomy)
* gastric cancer with duodenal involvement
* intraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04227951
Study Brief:
Protocol Section:
NCT04227951