Overall SurvivalNCT04050787
Spleen-Preserving No. 10 Lymph Node Dissection in Gastric Cancer
A study testing D2 Lymphadenectomy including No. 10 and D2 lymphadenectomy excluding No. 10 in people with Overall Survival, run by Jian Suo at 1 site in China.
Trial summary
This study is to conduct a randomized controlled trial of two kinds of radical gastrectomy for patients with proximal gastric cancer. One is laparoscopic D2 radical total gastrectomy combined with spleen-preserving No.10 lymph node dissection , another one is laparoscopic D2 radical total gastrectomy without clearing… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Overall Survival
- What is being tested?
- D2 Lymphadenectomy including No. 10 and D2 lymphadenectomy excluding No. 10
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2019to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 80 years
- Primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- American Society of Anesthesiology score (ASA) class I, II, or III
- Written informed consent
Who cannot join
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- History of other malignant disease within past five years
Show all 13Show fewer
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of predicted values
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin, 130021
Jian Suo, 181 8687 1293, suojian0066@126.com
Yuchen Guo, 13630598312, guoyuchen8688@live.com
About this study
Official title: Study on Laparoscopic No. 10 Lymph Node Dissection With Preservation of Spleen for Advanced Middle or Upper Third Gastric Cancer
This study is to conduct a randomized controlled trial of two kinds of radical gastrectomy for patients with proximal gastric cancer. One is laparoscopic D2 radical total gastrectomy combined with spleen-preserving No.10 lymph node dissection , another one is laparoscopic D2 radical total gastrectomy without clearing the No. 10 lymph nodes of the spleen. We explore the effect of the two procedures on the survival of patients, as well as the surgical complications associated with the two procedures, the number of lymph node dissection, the operation time and the amount of intraoperative blood loss. Furthermore, we also want to discuss the application value of laparoscopic lymph node dissection for spleen preservation in radical gastrectomy for proximal gastric cancer.
- Conditions
- Overall Survival
- Being tested
- D2 Lymphadenectomy including No. 10, D2 lymphadenectomy excluding No. 10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D2 Lymphadenectomy including No. 10Procedure or surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
D2 lymphadenectomy excluding No. 10Procedure or surgery
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy excluding spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
| Study group | Role | What they receive |
|---|---|---|
| D2 Lymphadenectomy including No. 10 | Experimental | lymphadenectomy including spleen-preserving No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group Receives: Procedure: D2 Lymphadenectomy including No. 10 |
| D2 lymphadenectomy excluding No. 10 | Active comparator | Laparoscopic total gastrectomy with D2 lymphadenectomy but without No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group Receives: Procedure: D2 lymphadenectomy excluding No. 10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival rate
Measured: 36 months
Secondary outcomes (5)
Morbidity
The early postoperative complication are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th.
Measured: 30 days; 36 months
3-year overall survival rate
Measured: 36 months
3-year recurrence pattern
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
Measured: 36 months
The number of lymph node dissection
Measured: 1 day
The number of positive lymph nodes
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start21 Jul 2019
- Primary completionJun 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overall SurvivalStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian Suo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian Suo, The First Hospital of Jilin University
- Investigators
- Jian Suo, Study chair, Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050787
- Sponsor's protocol ID
- No. 10 Lymph Node Dissection
- Status last verified
- Aug 2019
- First submitted
- 6 Aug 2019
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Laparoscopic No. 10 Lymph Node Dissection With Preservation of Spleen for Advanced Middle or Upper Third Gastric Cancer
- ClinicalTrials.gov ID
- NCT04050787
- Acronym / sponsor ID
- No. 10 Lymph Node Dissection
- Conditions
- Overall Survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jian SuoUniversity, hospital or other
- Study start
- 21 Jul 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 8 Aug 2019 (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.
This study is to conduct a randomized controlled trial of two kinds of radical gastrectomy for patients with proximal gastric cancer. One is laparoscopic D2 radical total gastrectomy combined with spleen-preserving No.10 lymph node dissection , another one is laparoscopic D2 radical total gastrectomy without clearing the No. 10 lymph nodes of the spleen. We explore the effect of the two procedures on the survival of patients, as well as the surgical complications associated with the two procedures, the number of lymph node dissection, the operation time and the amount of intraoperative blood loss. Furthermore, we also want to discuss the application value of laparoscopic lymph node dissection for spleen preservation in radical gastrectomy for proximal gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D2 Lymphadenectomy including No. 10 | Experimental | Procedure: D2 Lymphadenectomy including No. 10lymphadenectomy including spleen-preserving No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group |
| D2 lymphadenectomy excluding No. 10 | Active comparator | Procedure: D2 lymphadenectomy excluding No. 10Laparoscopic total gastrectomy with D2 lymphadenectomy but without No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age from 18 to 80 years
- Primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
Key exclusion criteria (13 listed)
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
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 |
|---|---|---|
| D2 Lymphadenectomy including No. 10After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy | Procedure or surgery | D2 Lymphadenectomy including No. 10 |
| D2 lymphadenectomy excluding No. 10After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy excluding spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy | Procedure or surgery | D2 lymphadenectomy excluding No. 10 |
Primary outcome
3-year disease free survival rate
Time frame: 36 months
5 secondary outcomes
Morbidity
Time frame: 30 days; 36 months
3-year overall survival rate
Time frame: 36 months
3-year recurrence pattern
Time frame: 36 months
The number of lymph node dissection
Time frame: 1 day
The number of positive lymph nodes
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jian Suo study chair
Jilin 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 D2 Lymphadenectomy including No. 10 and D2 lymphadenectomy excluding No. 10 in people with Overall Survival, run by Jian Suo 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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 8 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Suo, Ph.D. (181 8687 1293, suojian0066@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival rate (time frame: 36 months). 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 8 Aug 2019.