Stomach NeoplasmsNCT02789891
Randomized Controlled Trials on Laparoscopic No. 14v LNS Dissection
A study testing D2 lymphadenectomy including No. 14v and lymphadenectomy excluding No. 14v in people with Stomach Neoplasms, run by Fujian Medical University.
Trial summary
The purpose of this study is to explore the short-term, long-term and oncological outcomes of laparoscopic No. 14v lymph node dissection in advanced lower third gastric cancer. Read more about this study
- Who is it for?
- Ages 10 to 75 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- D2 lymphadenectomy including No. 14v and lymphadenectomy excluding No. 14v
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jan 2024
- 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 10 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary lower third 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
Show all 19Show fewer
- Exclusion Criteria:• 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 envelop important vessels
- History of other malignant disease within past five years
- 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
Who cannot join
None listed.
About this study
Official title: Randomized Controlled Trials on Laparoscopic No. 14v Lymph Node Dissection for Advanced Lower Third Gastric Cancer
The purpose of this study is to explore the short-term, long-term and oncological outcomes of laparoscopic No. 14v lymph node dissection in advanced lower third gastric cancer.
Read the detailed description
A prospective randomized comparison of laparoscopic No. 14v lymph node dissection in advanced lower third gastric cancer will be performed, to evaluate the short-term, long-term and oncological outcomes. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.
- Conditions
- Stomach Neoplasms
- Being tested
- D2 lymphadenectomy including No. 14v, lymphadenectomy excluding No. 14v
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D2 lymphadenectomy including No. 14vProcedure or surgery
After exclusion of T4b, or distant metastasis case by diagnostic laparoscopy, Laparoscopic distal with D2 lymphadenectomy including No. 14v Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience
lymphadenectomy excluding No. 14vProcedure or surgery
After exclusion of T4b, or distant metastasis case by diagnostic laparoscopy, Laparoscopic distal gastrectomy with D2 lymphadenectomy excluding No. 14v Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience
| Study group | Role | What they receive |
|---|---|---|
| D2 Lymphadenectomy including No. 14v | Experimental | Laparoscopic distal gastrectomy with D2 lymphadenectomy including No. 14v lymph node dissection will be performed for the treatment of patients assigned to this group Receives: Procedure: D2 lymphadenectomy including No. 14v |
| D2 lymphadenectomy excluding No. 14v | Active comparator | Laparoscopic distal gastrectomy with D2 lymphadenectomy excluding No. 14v lymph node dissection will be performed for the treatment of patients assigned to this group Receives: Procedure: lymphadenectomy excluding No. 14v |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease overall survival rate
Measured: 36 months
Secondary outcomes (30)
No.14v Lymph node metastasis rate
Measured: 10 days
Morbidity and mortality
The early postoperative complication and mortality 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 free 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
Time to first ambulation
The data of postoperative recovery course.
Measured: 10 days
The number of lymph node dissection
Measured: 10day
The variation of weight
The variation of weight on postoperative 3, 6, 9 and 12 months
Measured: 12 months
The daily highest body temperature
The daily highest body temperature before discharge
Measured: 7 day
Time to first flatus
Measured: 10 days
Time to first liquid diet
Measured: 10 days
Time to soft diet
Measured: 10 days
Duration of hospital stay
Measured: 10 days
The amount of abdominal drainage
Measured: 10 days
Blood transfusion
Measured: 10 days
The number of positive lymph nodes
Measured: 1 day
Intraoperative lymph node dissection time
intraoperative No.14v lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node, cardial area lymph node
Measured: 1 day
Intraoperative blood loss
Measured: 1 day
Intraoperative injury
Measured: 1 day
The amount of use of titanium clip
Measured: 1 day
The rate of conversion to laparotomy
Measured: 1 day
The variation of cholesterol
The variation of cholesterol on postoperative 3, 6, 9 and 12 months
Measured: 12 months
The variation of albumin
The variation of albumin on postoperative 3, 6, 9 and 12 months
Measured: 12 months
The results of endoscopy
the results of endoscopy on postoperative 3 and 12 months
Measured: 12 months
The values of white blood cell count
the values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded
Measured: 7 days
The values of hemoglobin
and the values of hemoglobin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Measured: 7 days
The values of C-reactive protein
and the values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Measured: 7 days
The values of prealbumin
and the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Measured: 7 days
The values of relevant immune cytokines
and the values of relevant immune cytokines including T cell percentage, T-helper lymphocytes (CD4+) percentage, T-suppressor lymphocytes (CD8+) percentage, natural killer (NK) cells percentage from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Measured: 7 days
Visual Analog Score for pain
the values of visual analog score for pain before operation and on postoperative day 1 to day 7 are recorded.
Measured: 7 days
EORTC QLQ-C30 and QLQ - STO22
European Organization fo Research and Treatment(EORTC) QLQ-C30 and QLQ - STO22 before operation and on postoperative month 6,12,36 are recorded.
Measured: Time Frame: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2021 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies 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
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789891
- Sponsor's protocol ID
- 2016-03
- Status last verified
- Feb 2020
- First submitted
- 29 May 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trials on Laparoscopic No. 14v Lymph Node Dissection for Advanced Lower Third Gastric Cancer
- ClinicalTrials.gov ID
- NCT02789891
- Acronym / sponsor ID
- 2016-03
- Conditions
- Stomach Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 3 Jun 2016 (estimated)
- 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.
The purpose of this study is to explore the short-term, long-term and oncological outcomes of laparoscopic No. 14v lymph node dissection in advanced lower third gastric cancer.
Detailed description
A prospective randomized comparison of laparoscopic No. 14v lymph node dissection in advanced lower third gastric cancer will be performed, to evaluate the short-term, long-term and oncological outcomes. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.
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. 14v | Experimental | Procedure: D2 lymphadenectomy including No. 14vLaparoscopic distal gastrectomy with D2 lymphadenectomy including No. 14v lymph node dissection will be performed for the treatment of patients assigned to this group |
| D2 lymphadenectomy excluding No. 14v | Active comparator | Procedure: lymphadenectomy excluding No. 14vLaparoscopic distal gastrectomy with D2 lymphadenectomy excluding No. 14v lymph node dissection will be performed for the treatment of patients assigned to this group |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Primary lower third 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
Key exclusion criteria (0 listed)
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. 14vAfter exclusion of T4b, or distant metastasis case by diagnostic laparoscopy, Laparoscopic distal with D2 lymphadenectomy including No. 14v Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience | Procedure or surgery | D2 Lymphadenectomy including No. 14v |
| lymphadenectomy excluding No. 14vAfter exclusion of T4b, or distant metastasis case by diagnostic laparoscopy, Laparoscopic distal gastrectomy with D2 lymphadenectomy excluding No. 14v Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience | Procedure or surgery | D2 lymphadenectomy excluding No. 14v |
Primary outcome
3-year disease overall survival rate
Time frame: 36 months
30 secondary outcomes
No.14v Lymph node metastasis rate
Time frame: 10 days
Morbidity and mortality
Time frame: 30 days; 36 months
3-year free survival rate
Time frame: 36 months
3-year recurrence pattern
Time frame: 36 months
Time to first ambulation
Time frame: 10 days
The number of lymph node dissection
Time frame: 10day
The variation of weight
Time frame: 12 months
The daily highest body temperature
Time frame: 7 day
Time to first flatus
Time frame: 10 days
Time to first liquid diet
Time frame: 10 days
Time to soft diet
Time frame: 10 days
Duration of hospital stay
Time frame: 10 days
The amount of abdominal drainage
Time frame: 10 days
Blood transfusion
Time frame: 10 days
The number of positive lymph nodes
Time frame: 1 day
Intraoperative lymph node dissection time
Time frame: 1 day
Intraoperative blood loss
Time frame: 1 day
Intraoperative injury
Time frame: 1 day
The amount of use of titanium clip
Time frame: 1 day
The rate of conversion to laparotomy
Time frame: 1 day
The variation of cholesterol
Time frame: 12 months
The variation of albumin
Time frame: 12 months
The results of endoscopy
Time frame: 12 months
The values of white blood cell count
Time frame: 7 days
The values of hemoglobin
Time frame: 7 days
The values of C-reactive protein
Time frame: 7 days
The values of prealbumin
Time frame: 7 days
The values of relevant immune cytokines
Time frame: 7 days
Visual Analog Score for pain
Time frame: 7 days
EORTC QLQ-C30 and QLQ - STO22
Time frame: Time Frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing D2 lymphadenectomy including No. 14v and lymphadenectomy excluding No. 14v in people with Stomach Neoplasms, run by Fujian Medical University.
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 19 inclusion and 0 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease overall 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 5 Feb 2020.