NCT05356156Not yet recruiting
The Safe Study of Routine Closure of Mesenteric Defects Versus Non-closure After Radical Gastrectomy
A Multicenter, Randomized, Controlled Clinical Trial of the Safety of Mesenteric Defects Closure After Radical Gastrectomy
Source: ClinicalTrials.gov · Last updated 2 May 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1968 (estimated)
- First submitted
- 23 Apr 2022
- Start date
- Apr 2022
- Primary completion date
- Mar 2027
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05356156
What you commit to
- Study type: Interventional
- Planned participants: 1968
- From Apr 2022 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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；
- History of unstable angina or myocardial infarction within 6 months；
- History of cerebral infarction or cerebral hemorrhage within 6 months；
- Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ；
Other
- Women during pregnancy or lactation；
- Severe liver and kidney dysfunction；
- Continuous application of glucocorticoid within 1 month (except for topical application)；
- The patient has participated in or is participating in other clinical studies (within 6 months).
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.