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

Primary Purpose

Gastric Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Closure of the mesenteric defects
Non-closure of the mesenteric defects
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • The First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Closure of the mesenteric defects

Non-closure of the mesenteric defects

Arm Description

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 will be performed after radical gastrectomy in patients with gastric or esophagogastric junction adenocarcinoma.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Incidence of postoperative intestinal obstruction
Refers to the incidence of postoperative intestinal obstruction observed during follow-up period.
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.

Full Information

First Posted
April 23, 2022
Last Updated
April 29, 2022
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05356156
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1968 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Closure of the mesenteric defects
Arm Type
Experimental
Arm Description
Closure of the mesenteric defects will be performed after radical gastrectomy in patients with gastric or esophagogastric junction adenocarcinoma.
Arm Title
Non-closure of the mesenteric defects
Arm Type
Active Comparator
Arm Description
Non-closure of the mesenteric defects will be performed after radical gastrectomy in patients with gastric or esophagogastric junction adenocarcinoma.
Intervention Type
Procedure
Intervention Name(s)
Closure of the mesenteric defects
Intervention Description
The surgically created mesenteric defects will be closed after radical gastrectomy with D1+/D2 lymph node dissection.
Intervention Type
Procedure
Intervention Name(s)
Non-closure of the mesenteric defects
Intervention Description
The surgically created mesenteric defects will not be closed after radical gastrectomy with D1+/D2 lymph node dissection.
Primary Outcome Measure Information:
Title
The incidence of internal hernia within 3 years after surgery
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
The incidence of intraoperative complications
Description
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.
Time Frame
up to 2 hours after surgery
Title
Incidence of postoperative intestinal obstruction
Description
Refers to the incidence of postoperative intestinal obstruction observed during follow-up period.
Time Frame
3 years
Title
Overall survival at 3 years after surgery
Description
The overall survival of patients with gastric or esophagogastric junction adenocarcinoma are evaluated at 3 years after radical gastrectomy.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zekuan Xu, M.D., Ph.D.
Phone
+86-025-68306844
Email
xuzekuan@njmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zekuan Xu, M.D., Ph.D.
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zekuan Xu, M.D., Ph.D.

12. IPD Sharing Statement

Learn more about this trial

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

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