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

NCT05356156 | Not Yet Recruiting

• 1 other identifier: JSGCU-2203
• Study Type: interventional
• Target: 1,968
• Locations: 1 country
• Sites: 1

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).

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The incidence of intraoperative complications

  up to 2 hours after surgery

• Incidence of postoperative intestinal obstruction

  3 years

• Overall survival at 3 years after surgery

  3 years

Study Arms (2)

Closure of the mesenteric defects

EXPERIMENTAL

Closure of the mesenteric defects will be performed after radical gastrectomy in patients with gastric or esophagogastric junction adenocarcinoma.

Procedure: Closure of the mesenteric defects

Non-closure of the mesenteric defects

ACTIVE COMPARATOR

Non-closure of the mesenteric defects will be performed after radical gastrectomy in patients with gastric or esophagogastric junction adenocarcinoma.

Procedure: Non-closure of the mesenteric defects

Interventions

Closure of the mesenteric defects PROCEDURE

The surgically created mesenteric defects will be closed after radical gastrectomy with D1+/D2 lymph node dissection.

Closure of the mesenteric defects

Non-closure of the mesenteric defects PROCEDURE

The surgically created mesenteric defects will not be closed after radical gastrectomy with D1+/D2 lymph node dissection.

Non-closure of the mesenteric defects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Zekuan Xu, M.D., Ph.D.

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zekuan Xu, M.D., Ph.D.

CONTACT

+86-025-68306844; xuzekuan@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2022
• First Posted: May 2, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

CN (1)