Gastric CancerNCT05356156
The Safe Study of Routine Closure of Mesenteric Defects Versus Non-closure After Radical Gastrectomy
A study testing Closure of the mesenteric defects and Non-closure of the mesenteric defects in people with Gastric Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Closure of the mesenteric defects and Non-closure of the mesenteric defects
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,968 participants
- Where
- 1 siteChina
- Study dates
- Apr 2022to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.；
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- 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.
Who cannot join
- 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；
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Zekuan Xu, M.D., Ph.D.
About this study
Official title: A Multicenter, Randomized, Controlled Clinical Trial of the Safety of Mesenteric Defects Closure After Radical Gastrectomy
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
- Being tested
- Closure of the mesenteric defects, Non-closure of the mesenteric defects
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure of the mesenteric defectsProcedure or surgery
The surgically created mesenteric defects will be closed after radical gastrectomy with D1+/D2 lymph node dissection.
Non-closure of the mesenteric defectsProcedure or surgery
The surgically created mesenteric defects will not be closed after radical gastrectomy with D1+/D2 lymph node dissection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Non-closure of the mesenteric defects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (3)
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.
Measured: up to 2 hours after surgery
Incidence of postoperative intestinal obstruction
Refers to the incidence of postoperative intestinal obstruction observed during follow-up period.
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study startApr 2022 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,968 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zekuan Xu, M.D., Ph.D., Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356156
- Sponsor's protocol ID
- JSGCU-2203
- Status last verified
- Apr 2022
- First submitted
- 23 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Clinical Trial of the Safety of Mesenteric Defects Closure After Radical Gastrectomy
- ClinicalTrials.gov ID
- NCT05356156
- Acronym / sponsor ID
- JSGCU-2203
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,968 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closure of the mesenteric defects | Experimental | Procedure: Closure of the mesenteric defectsClosure of the mesenteric defects will be performed after radical gastrectomy in patients with gastric or esophagogastric junction adenocarcinoma. |
| Non-closure of the mesenteric defects | Active comparator | Procedure: Non-closure of the mesenteric defectsNon-closure of the mesenteric defects will be performed after radical gastrectomy in patients with gastric or esophagogastric junction adenocarcinoma. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)；
Key exclusion criteria (11 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closure of the mesenteric defectsThe surgically created mesenteric defects will be closed after radical gastrectomy with D1+/D2 lymph node dissection. | Procedure or surgery | Closure of the mesenteric defects |
| Non-closure of the mesenteric defectsThe surgically created mesenteric defects will not be closed after radical gastrectomy with D1+/D2 lymph node dissection. | Procedure or surgery | Non-closure of the mesenteric defects |
Primary outcome
The incidence of internal hernia within 3 years after surgery
Time frame: 3 years
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 secondary outcomes
The incidence of intraoperative complications
Time frame: up to 2 hours after surgery
Incidence of postoperative intestinal obstruction
Time frame: 3 years
Overall survival at 3 years after surgery
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zekuan Xu, M.D., Ph.D. principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure of the mesenteric defects and Non-closure of the mesenteric defects in people with Gastric Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zekuan Xu, M.D., Ph.D. (+86-025-68306844, xuzekuan@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of internal hernia within 3 years after surgery (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.