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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic bursectomy and D2 lymphadenectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the 3-year disease-free survival rate | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| the 3-year overall survival rate | up to 36 months | |
| the 5-year disease-free survival rate | up to 5 years | |
| the 5-year overall survival rate |
| Measure | Description | Time Frame |
|---|---|---|
| the time to firstly flaunt | up to 36 months | |
| the time of hospital stay | up to 36 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Wan, professor | Contact | 0086-020-13710637721 | reiqiwj@aliyun.com | |
| Liao-nan Zou, professor | Contact | 0086-020-13423663496 | 13423663496@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin Wan, professor | Guangdong Provincial Hospital of Traditional Chinese Medicine | Principal Investigator |
| Liao-nan Zou, professor | Guangdong Provincial Hospital of Traditional Chinese Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GI surgery,Guangdong Provincial Hospital of Traditional Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26170983 | Result | 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. | |
| 26675932 | Result | Zou 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. |
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|
| Laparoscopic D2 lymphadenectomy | Procedure | D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN). |
|
| up to 5 years |
| the operation time | up to 36 months |
| the total blood loss | up to 36 months |
| the number of pancreatic leakage | up to 36 months |
| the number of lymph nodes dissected | up to 36 months |
| the number of conversion to open laparotomy | up to 36 months |
| the number of bowel obstruction | up to 36 months |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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