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The aim of this study is to verify the safety and efficacy of single or reduced ports laparoscopic gastrectomy for advanced gastric cancer.
Since two cases of single-incision laparoscopic gastrectomy in early gastric cancer were reported in 2011, the safety and efficacy of single-incision laparoscopic gastrectomy in early gastric cancer have been reported several times.
Recently, the feasibility of laparoscopic single-incision gastrectomy in some advanced gastric cancer has already been reported.
The total number of retrieved lymph nodes during gastric cancer surgery is one of the most important indicators for securing oncological safety and predicting the therapeutic effect in gastric cancer surgery.
Therefore, in order to prospectively evaluate the efficacy of single-incision or reduced-port laparoscopic gastrectomy for advanced gastric cancer as an oncological operation, the purpose of this study is to evaluate the number of resected lymph nodes after D2 lymph node dissection in single-incision or reduced-port laparoscopic gastrectomy for advanced gastric cancer.
All surgeries are performed as single-incision laparoscopic surgery using a 3-4 cm umbilical incision, and D2 lymph node dissection is performed according to the Japanese gastric cancer treatment guidelines 2018 by the Japanese Gastric Cancer Association.
When an additional trocar is required, it is classified as reduced port laparoscopy when one additional trocar is added.
For surgical assistance, including effective visual field development during surgery, a self intra-corporeal retractor (FJ clip®, or Internal organ retractor®) or an additional trocar (up to 1 trocar) could be used.
An articulating laparoscopic surgical instrument (Artisential ®) can be used for safe access to difficult areas of the D2 lymph node dissection, such as the superior border of the pancreas.
Before the end of the surgery, the surgeon evaluates the completeness of D2 lymph node dissection and radical resection of the primary tumor(R0 resection). If insufficient, the operation is converted to multi-port laparoscopic surgery or open surgery, and additional D2 lymph node dissection and tumor resection are performed, and those cases are recorded separately in the registry as multiport/open conversion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single port or reduced ports | Experimental | Single port or reduced ports laparoscopic distal gastrectomy and D2 lymph node dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single port or reduced ports laparoscopic distal gastrectomy and D2 lymph node dissection | Procedure | Single port or reduced ports laparoscopic distal gastrectomy and D2 lymph node dissection |
| Measure | Description | Time Frame |
|---|---|---|
| number of retrieved lymph nodes | number of retrieved lymph nodes during operation | during operation |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complications | Postoperative complications are problems that can happen after participants have had surgery but which were not intended. | 3 year |
| Quality of life of the participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YunSuhk Suh, M.D., Ph.D. | ysksuh@gmail.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22044252 | Background | Lee JH, Lee MS, Kim HH, Park DJ, Lee HJ, Yang HK, Park KU. Comparison of single-incision laparoscopic distal gastrectomy and laparoscopic distal gastrectomy for gastric cancer in a porcine model. J Laparoendosc Adv Surg Tech A. 2011 Dec;21(10):935-40. doi: 10.1089/lap.2011.0280. Epub 2011 Nov 1. | |
| 27510844 | Background |
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The patient's quality of life is assessed using the widely used quality of life questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), sto22) before surgery (within 1 month before the day of surgery), within 1 week after surgery, within 1 month after surgery, within 3 months after surgery, within 6 months after surgery, and within 12 months after surgery, respectively.
| before surgery (within 1 month before the day of surgery), within 1 week after surgery, within 1 month after surgery, within 3 months after surgery, within 6 months after surgery, and within 12 months after surgery |
| 3 year relapse-free survival | 3 year relapse-free survival | 3 year |
| Omori T, Fujiwara Y, Moon J, Sugimura K, Miyata H, Masuzawa T, Kishi K, Miyoshi N, Tomokuni A, Akita H, Takahashi H, Kobayashi S, Yasui M, Ohue M, Yano M, Sakon M. Comparison of Single-Incision and Conventional Multi-Port Laparoscopic Distal Gastrectomy with D2 Lymph Node Dissection for Gastric Cancer: A Propensity Score-Matched Analysis. Ann Surg Oncol. 2016 Dec;23(Suppl 5):817-824. doi: 10.1245/s10434-016-5485-8. Epub 2016 Aug 10. |
| 30187335 | Background | Omori T, Fujiwara Y, Yamamoto K, Yanagimoto Y, Sugimura K, Masuzawa T, Kishi K, Takahashi H, Yasui M, Miyata H, Ohue M, Yano M, Sakon M. The Safety and Feasibility of Single-Port Laparoscopic Gastrectomy for Advanced Gastric Cancer. J Gastrointest Surg. 2019 Jul;23(7):1329-1339. doi: 10.1007/s11605-018-3937-0. Epub 2018 Sep 5. |
| 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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