The Safe Study of Routine Closure of Mesenteric Defects Versus Non-closure After Radical Gastrectomy

Gastric Cancer Clinical Trial

Official title:

A Multicenter, Randomized, Controlled Clinical Trial of the Safety of Mesenteric Defects Closure After Radical Gastrectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05356156
• Other study ID #: JSGCU-2203
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2022
• Est. completion date: March 2027

Study information

• Verified date: April 2022
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Zekuan Xu, M.D., Ph.D.
• Phone: +86-025-68306844
• Email: xuzekuan[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1968
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of internal hernia within 3 years after surgery	Internal hernia were identified by surgical exploration or abdominal computed tomography (CT) from surgical and medical records during the postoperative 3 years of follow-up.	3 years
Secondary	The incidence of intraoperative complications	The intraoperative complications occur from the beginning of skin cutting to the completion of sewn skin, including surgical complications, anesthesia related complications and pneumoperitoneum related complications.	up to 2 hours after surgery
Secondary	Incidence of postoperative intestinal obstruction	Refers to the incidence of postoperative intestinal obstruction observed during follow-up period.	3 years
Secondary	Overall survival at 3 years after surgery	The overall survival of patients with gastric or esophagogastric junction adenocarcinoma are evaluated at 3 years after radical gastrectomy.	3 years