The Safe Study of Routine Closure of Mesenteric Defects Versus Non-closure After Radical Gastrectomy
NCT ID: NCT05356156
Last Updated: 2022-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1968 participants
INTERVENTIONAL
2022-04-30
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Closure of the mesenteric defects
Closure of the mesenteric defects will be performed after radical gastrectomy in patients with gastric or esophagogastric junction adenocarcinoma.
Closure of the mesenteric defects
The surgically created mesenteric defects will be closed after radical gastrectomy with D1+/D2 lymph node dissection.
Non-closure of the mesenteric defects
Non-closure of the mesenteric defects will be performed after radical gastrectomy in patients with gastric or esophagogastric junction adenocarcinoma.
Non-closure of the mesenteric defects
The surgically created mesenteric defects will not be closed after radical gastrectomy with D1+/D2 lymph node dissection.
Interventions
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Closure of the mesenteric defects
The surgically created mesenteric defects will be closed after radical gastrectomy with D1+/D2 lymph node dissection.
Non-closure of the mesenteric defects
The surgically created mesenteric defects will not be closed after radical gastrectomy with D1+/D2 lymph node dissection.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
75 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Principal Investigators
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Zekuan Xu, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Zekuan Xu, M.D., Ph.D.
Role: primary
Other Identifiers
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JSGCU-2203
Identifier Type: -
Identifier Source: org_study_id
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