Gastric Cancer Stage IILBDLNCT02969148
Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in Advanced Gastric Cancer
A study testing Laparoscopic bursectomy and D2 lymphadenectomy and Laparoscopic D2 lymphadenectomy in people with Gastric Cancer Stage II and Gastric Cancer Stage III, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
To investigate the clinical efficacy and safety of laparoscopic bursectomy and D2 lymphadenectomy (LBDL group) versus laparoscopic D2 lymphadenectomy (LDL group) in advanced gastric cancer by prospective randomized controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer Stage II, Gastric Cancer Stage III
- What is being tested?
- Laparoscopic bursectomy and D2 lymphadenectomy and Laparoscopic D2 lymphadenectomy
- 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
- Nov 2016to Nov 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age limits is 18-80 years old;
- T3-T4 resectable gastric carcinoma,confirmed by CT and pathology.
- The preoperative imaging confirmed that the tumor did not involve adjacent organs;
- American Society of anesthesiologists (ASA) score less than or equal to Level 3;
- Criteria of performance status karnofsky is greater than or equal to 60.
Who cannot join
- The patients' age limits is Less than 18 years old, or more than 80 years old;
- The preoperative imaging confirmed that the tumor involve adjacent organs;
- The tumor have been finding distant metastases;
- American Society of anesthesiologists (ASA) score more than 3;
- Criteria of performance status karnofsky is lower than 60;
- There is a laparoscopic surgery contraindications.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
GI surgery,Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120
liao-nan Zou, professor, 0086-020-13423663496, 13423663496@163.com
xin-quan Lu, Dr, 0086-020-18898607919, 18898607919@163.com
About this study
Official title: Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in II,III Stage Gastric Carcinoma: A Prospective, Randomized, Single Blind, Parallel Group Clinical Trial
To investigate the clinical efficacy and safety of laparoscopic bursectomy and D2 lymphadenectomy (LBDL group) versus laparoscopic D2 lymphadenectomy (LDL group) in advanced gastric cancer by prospective randomized controlled clinical trial.
Read the detailed description
To compare the LBDL group and LDL group in the advanced gastric cancer. A prospective randomized controlled trial will be performed in the GI department, Guangdong provincial hospital of Chinese Medicine from November 2016 to November 2024. The sample size，100 cases with advanced gastric cancer, will be needed after calculated by the statistics. The 100 cases will be randomly divided into two groups: LBDL group and LDL group. Primary outcomes are the 3 years' Disease-free survival (DFS) rate, The secondary outcomes are the 3 years' and 5 years' Disease-free survival (DFS) rate, the 3 years and 5 years Overall survival（OS）rate, operative time, the total blood loss, the intra-operative complication and the post-operative complication, the number of lymph nodes dissected, the number of conversion to open laparotomy, and the other outcomes are the average time of ground activities, the hospital stay. The data in two groups will be compared.
- Conditions
- Gastric Cancer Stage II, Gastric Cancer Stage III
- Being tested
- Laparoscopic bursectomy and D2 lymphadenectomy, Laparoscopic D2 lymphadenectomy
- Keywords
- Laparoscopic, Bursectomy, D2 lymphadenectomy, Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic bursectomy and D2 lymphadenectomyProcedure or surgery
The anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN) by laparoscopy，this is Laparoscopic bursectomy and D2 lymphadenectomy.
Laparoscopic D2 lymphadenectomyProcedure or surgery
D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN).
| Study group | Role | What they receive |
|---|---|---|
| The bursectomy and D2 lymphadenectomy | Experimental | Laparoscopic bursectomy and D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach are that anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN) Receives: Procedure: Laparoscopic bursectomy and D2 lymphadenectomy |
| The D2 lymphadenectomy | Active comparator | Laparoscopic D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach is that D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN) without dissociation of anterior lobe of transverse mesocolon and capsula pancreatis. Receives: Procedure: Laparoscopic D2 lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the 3-year disease-free survival rate
Measured: up to 36 months
Secondary outcomes (9)
the 3-year overall survival rate
Measured: up to 36 months
the 5-year disease-free survival rate
Measured: up to 5 years
the 5-year overall survival rate
Measured: up to 5 years
the operation time
Measured: up to 36 months
the total blood loss
Measured: up to 36 months
the number of pancreatic leakage
Measured: up to 36 months
the number of lymph nodes dissected
Measured: up to 36 months
the number of conversion to open laparotomy
Measured: up to 36 months
the number of bowel obstruction
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2022 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric Cancer Stage IIStudies 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
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Wan, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Jin Wan, professor, Principal investigator, Guangdong Provincial Hospital of Traditional Chinese MedicineLiao-nan Zou, professor, Study director, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969148
- Sponsor's protocol ID
- LBDL1
- Acronym
- LBDL
- Status last verified
- Nov 2016
- First submitted
- 10 Nov 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Zou LN, He YB, Li HM, Diao DC, Mo DL, Wang W, Wan J. Surgical skills for laparoscopic resection of the bursa omentalis and lymph node scavenging with radical gastrectomy. Oncol Lett. 2015 Jul;10(1):99-102. doi: 10.3892/ol.2015.3226. Epub 2015 May 19.
PubMed 26170983Zou L, Xiong W, Mo D, Chen G, He Y, Li H, Tan P, Wang W, Wan J. Totally laparoscopic complete bursectomy and D2 lymphadenectomy in radical total gastrectomy: an outside bursa omentalis approach. Surg Endosc. 2016 Sep;30(9):4152. doi: 10.1007/s00464-015-4702-z. Epub 2015 Dec 16.
PubMed 26675932
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in II,III Stage Gastric Carcinoma: A Prospective, Randomized, Single Blind, Parallel Group Clinical Trial
- ClinicalTrials.gov ID
- NCT02969148
- Acronym / sponsor ID
- LBDL / LBDL1
- Conditions
- Gastric Cancer Stage II, Gastric Cancer Stage III
- Keywords
- Laparoscopic, Bursectomy, D2 lymphadenectomy, Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 21 Nov 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.
To investigate the clinical efficacy and safety of laparoscopic bursectomy and D2 lymphadenectomy (LBDL group) versus laparoscopic D2 lymphadenectomy (LDL group) in advanced gastric cancer by prospective randomized controlled clinical trial.
Detailed description
To compare the LBDL group and LDL group in the advanced gastric cancer. A prospective randomized controlled trial will be performed in the GI department, Guangdong provincial hospital of Chinese Medicine from November 2016 to November 2024. The sample size，100 cases with advanced gastric cancer, will be needed after calculated by the statistics. The 100 cases will be randomly divided into two groups: LBDL group and LDL group. Primary outcomes are the 3 years' Disease-free survival (DFS) rate, The secondary outcomes are the 3 years' and 5 years' Disease-free survival (DFS) rate, the 3 years and 5 years Overall survival（OS）rate, operative time, the total blood loss, the intra-operative complication and the post-operative complication, the number of lymph nodes dissected, the number of conversion to open laparotomy, and the other outcomes are the average time of ground activities, the hospital stay. The data in two groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The bursectomy and D2 lymphadenectomy | Experimental | Procedure: Laparoscopic bursectomy and D2 lymphadenectomyLaparoscopic bursectomy and D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach are that anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN) |
| The D2 lymphadenectomy | Active comparator | Procedure: Laparoscopic D2 lymphadenectomyLaparoscopic D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach is that D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN) without dissociation of anterior lobe of transverse mesocolon and capsula pancreatis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The age limits is 18-80 years old;
- T3-T4 resectable gastric carcinoma,confirmed by CT and pathology.
- The preoperative imaging confirmed that the tumor did not involve adjacent organs;
- American Society of anesthesiologists (ASA) score less than or equal to Level 3;
- Criteria of performance status karnofsky is greater than or equal to 60.
Key exclusion criteria (6 listed)
- The patients' age limits is Less than 18 years old, or more than 80 years old;
- The preoperative imaging confirmed that the tumor involve adjacent organs;
- The tumor have been finding distant metastases;
- American Society of anesthesiologists (ASA) score more than 3;
- Criteria of performance status karnofsky is lower than 60;
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 |
|---|---|---|
| Laparoscopic bursectomy and D2 lymphadenectomyThe anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN) by laparoscopy，this is Laparoscopic bursectomy and D2 lymphadenectomy. | Procedure or surgery | The bursectomy and D2 lymphadenectomy |
| Laparoscopic D2 lymphadenectomyD2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN). | Procedure or surgery | The D2 lymphadenectomy |
Primary outcome
the 3-year disease-free survival rate
Time frame: up to 36 months
9 secondary outcomes
the 3-year overall survival rate
Time frame: up to 36 months
the 5-year disease-free survival rate
Time frame: up to 5 years
the 5-year overall survival rate
Time frame: up to 5 years
the operation time
Time frame: up to 36 months
the total blood loss
Time frame: up to 36 months
the number of pancreatic leakage
Time frame: up to 36 months
the number of lymph nodes dissected
Time frame: up to 36 months
the number of conversion to open laparotomy
Time frame: up to 36 months
the number of bowel obstruction
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Results publication: PubMed 26170983Zou LN, He YB, Li HM, Diao DC, Mo DL, Wang W, Wan J. Surgical skills for laparoscopic resection of the bursa omentalis and lymph node scavenging with radical gastrectomy. Oncol Lett. 2015 Jul;10(1):99-102. doi: 10.3892/ol.2015.3226. Epub 2015 May 19.
- Results publication: PubMed 26675932Zou L, Xiong W, Mo D, Chen G, He Y, Li H, Tan P, Wang W, Wan J. Totally laparoscopic complete bursectomy and D2 lymphadenectomy in radical total gastrectomy: an outside bursa omentalis approach. Surg Endosc. 2016 Sep;30(9):4152. doi: 10.1007/s00464-015-4702-z. Epub 2015 Dec 16.
- Individual participant dataSharing planned: Yes
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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.
Jin Wan, professor principal investigator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Liao-nan Zou, professor study director
Guangdong Provincial Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic bursectomy and D2 lymphadenectomy and Laparoscopic D2 lymphadenectomy in people with Gastric Cancer Stage II and Gastric Cancer Stage III, run by Guangdong Provincial Hospital of Traditional Chinese Medicine 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 5 inclusion and 6 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 21 Nov 2016. 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 Jin Wan, professor (0086-020-13710637721, reiqiwj@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the 3-year disease-free survival rate (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02969148, which also lists 2 linked publications.
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 21 Nov 2016.