Clinical trial NCT05356156: The Safe Study of Routine Closure of Mesenteric Defects Versus Non-closure After Radical Gastrectomy
Official title: A Multicenter, Randomized, Controlled Clinical Trial of the Safety of Mesenteric Defects Closure After Radical Gastrectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 1968
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the incidence of internal hernia, overall survival and short-term surgical safety of routine closure of the surgically created mesenteric defects versus non-closure for patients with adenocarcinoma of the gastric or esophagogastric junction who underwent radical gastrectomy (D1+/D2 lymph node dissection).


Eligibility criteria: Inclusion Criteria:

* Aged 18-75 years；
* Primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach or esophagogastric junction, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), mixed adenocarcinoma, etc.；
* The gastric primary lesion is located in the antrum, body or fundus of stomach or the esophagogastric junction. It is expected that radical gastrectomy with D1+/D2 lymph node dissection achieves R0 resection (multiple primary cancers are also applicable)；
* BMI(Body Mass Index) \< 30 kg/m2；
* No history of upper abdominal surgery (except for laparoscopic cholecystectomy)；
* No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.；
* Preoperative ECOG (Eastern Cooperative Oncology Group) performance status score 0 or 1；
* Preoperative ASA (American Society of Anesthesiologists) scoring I-III；
* Sufficient vital organ functions；
* Signed informed consent.

Exclusion Criteria:

* Women during pregnancy or lactation；
* Suffer from other malignant tumors within 5 years；
* Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring systemic treatment；
* Severe mental illness；
* Severe respiratory disease；
* Severe liver and kidney dysfunction；
* History of unstable angina or myocardial infarction within 6 months；
* History of cerebral infarction or cerebral hemorrhage within 6 months；
* Continuous application of glucocorticoid within 1 month (except for topical application)；
* Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ；
* The patient has participated in or is participating in other clinical studies (within 6 months).

Primary outcomes:
measure: The incidence of internal hernia within 3 years after surgery
timeFrame: 3 years
Secondary outcomes:
measure: The incidence of intraoperative complications
timeFrame: up to 2 hours after surgery
measure: Incidence of postoperative intestinal obstruction
timeFrame: 3 years
measure: Overall survival at 3 years after surgery
timeFrame: 3 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Zekuan Xu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: