Clinical Evidence – Gastrectomy
The following selected publications support the clinical efficacy of da Vinci® General Surgery for gastrectomy.
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Hyung WJ. Application of minimally invasive treatment for early gastric cancer.
Journal of Surgical Oncology. 2004: 85(4).
Abstract
Background and Objectives: Although various types of minimally invasive treatment have emerged as the best front-line therapies for early gastric cancer (EGC), there have been no established indications that these attempts are applicable. The purpose of this study was to propose indications for the application of minimally invasive therapy for EGC. Methods: A total of 566 patients with EGC who had undergone gastrectomy with D2 or more extended lymphadenectomy, from July 1993 to December 1997 were retrospectively analyzed. The risk factors that determine lymph node metastasis were investigated by univariate and multivariate analysis. Results: The rate of lymph node metastasis was 11.8% for all EGC, 3.4% for mucosal cancer, and 21.0% for submucosal cancer. Lymph node metastasis was associated with submucosal invasion, larger tumor size, undifferentiated histology, and the presence of lymphatic or blood vessel invasion (LBVI) by univariate and multivariate analyses. When LBVI was absent, there was no lymph node metastasis if the tumor was smaller than 2.5 cm with differentiated histology, and smaller than 1.5 cm with undifferentiated histology, regardless of depth of invasion. Extra-perigastric lymph node metastases were noted in patients with submucosal tumors that have LBVI while none of mucosal cancer showed extra-perigastric lymph node metastases. Conclusions: Minimally invasive treatment can be possibly applied for patients with EGC using these four independent risk factors for lymph node metastasis in EGC. For mucosal cancers, EMR is indicated for EGCs without lymph node involvement based on tumor size and histology. When we found LBVI by pathologic examination after EMR, gastrectomy with D1 lymph node dissection is mandatory. For submucosal cancers, patients with small tumors could be treated with laparoscopic wedge resection without lymph node dissection. However, patients with larger sized tumors or tumors with LBVI should be treated with extended (D2) lymph node dissection.
American Cancer Society Facts & Figures 2009. Available from: http://www.cancer.org/downloads/STT/500809web.pdf
Parkin DM. Global Cancer Statistics, 2002. CA Cancer J Clin 2005;55;74-108.
Abstract
Estimates of the worldwide incidence, mortality and prevalence of 26 cancers in the year 2002 are now available in the GLOBOCAN series of the International Agency for Research on Cancer. The results are presented here in summary form, including the geographic variation between 20 large "areas" of the world. Overall, there were 10.9 million new cases, 6.7 million deaths, and 24.6 million persons alive with cancer (within three years of diagnosis). The most commonly diagnosed cancers are lung (1.35 million), breast (1.15 million), and colorectal (1 million); the most common causes of cancer death are lung cancer (1.18 million deaths), stomach cancer (700,000 deaths), and liver cancer (598,000 deaths). The most prevalent cancer in the world is breast cancer (4.4 million survivors up to 5 years following diagnosis). There are striking variations in the risk of different cancers by geographic area. Most of the international variation is due to exposure to known or suspected risk factors related to lifestyle or environment, and provides a clear challenge to prevention.
Nakajima T. Gastric cancer treatment guidelines in Japan. Gastric Cancer. 2002;5(1):1-5.
Abstract
Recent developments in treatment modalities for gastric cancer have allowed the selection of a variety of treatments, and this has resulted in some confusion in daily practice. The Japan Gastric Cancer Association issued the first edition of Gastric cancer treatment guidelines in March, 2001 to provide a common basis of understanding of the extent of disease and selection of proper treatment among doctors, patients, and their families.
Song J. Robot-Assisted Gastrectomy With Lymph Node Dissection for Gastric Cancer. Ann Surg. 2009 Jun;249(6):927-32.
Abstract
To evaluate the technical feasibility, effectiveness, and safety of robot-assisted gastrectomy (RAG) with lymphadenectomy, using the da Vinci system through analyses of our initial series of 100 consecutive patients. SUMMARY BACKGROUND DATA:: The application of robotic surgery was proven to be one of the best cutting-edge technologies for successful minimally invasive surgery by providing solutions to the many drawbacks of laparoscopic surgery, yet few reports have studied robotic surgery in gastric cancer. METHODS:: A review of a prospectively designed database at our institute from July 2005 to October 2007 revealed a series of 100 consecutive RAG patients with a preoperative diagnosis of early gastric cancer. Clinicopathologic characteristics and surgical outcomes were analyzed. RESULTS:: All operations were performed successfully without open or laparoscopic conversion. There were 33 total gastrectomies and 67 subtotal gastrectomies with D1+beta or extended lymphadenectomy (D2). The mean total operation time and console time were 231 and 150 minutes, respectively. There were 13 postoperative morbidities and 1 postoperative mortality. The first flatus was noted on postoperative day 2.9, soft diet was started on postoperative day 4.2, and the mean postoperative hospital stay was 7.8 days. Although all patients were diagnosed as early gastric cancer preoperatively, the final pathology report revealed that 19 patients exhibited a depth deeper than T2. The mean number of retrieved lymph nodes was 36.7 (range, 11-83). None of the specimens showed microscopic tumor involvement in the resection line. CONCLUSIONS:: This study demonstrated that RAG with lymphadenectomy can be applied safely and effectively for patients with gastric cancer.
Patriti A. Robot-assisted laparoscopic total and partial gastric resection with D2 lymph node dissection for adenocarcinoma. Surgical Endoscopy. 2008 Dec; 22(12):2753-60.
Abstract
Lymph node dissection and esophageal anastomosis, considered the more demanding steps of laparoscopic gastrectomy for gastric adenocarcinoma, can be performed with the use of a remote-controlled robot. Methods: Thirteen patients with a histologically proved gastric cancer (six stage I, six stage II, and one stage III) were enrolled in a prospective study to assess feasibility and safety of the Da Vinci surgical system in total and partial gastrectomy with extended lymph node dissection. Outcome measures were conversion rate, intra- and postoperative morbidity and mortality, operative time, blood loss, number of lymph nodes harvested, and macroscopic and microscopic evaluation of resection margins. Results: Eight distal, four total, and one proximal laparoscopic gastrectomies were completed without conversion. Extended lymph node dissection, and esophagojejunal and esophagogastric anastomoses were successfully carried out using the da Vinci System. Mean operative time was 286 ± 32.6 min and blood loss was 103 ± 87.5 ml. Mean number of nodes retrieved was 28.1 ± 8.3 and all resection margins were negative. There was no mortality. Trocar bleeding requiring laparoscopy was the only major complication encountered. No recurrence occurred during a mean follow-up time of 12.2 ± 4.5 months. Conclusions: Robot-assisted laparoscopic lymph node dissection and esophageal anastomosis are feasible and safe. Longer follow-up time and randomized studies are needed to evaluate long-term outcome and clinical advantages of this new technology.
Kim MC. Robotic gastrectomy for gastric cancer: surgical techniques and clinical merits. Surg Endosc. 2010 Mar;24(3):610-5.
Abstract
Robotic gastrectomy in the setting of gastric cancer is reported by some investigators. However, no study has compared robotic surgery with open or laparoscopic surgery for patients with gastric cancer. This study aimed to determine the clinical benefits of robotic gastrectomy over open and laparoscopic gastrectomy for the treatment of gastric cancer. Methods: After the introduction of the da Vinci surgical system in November 2007 at the authors' hospital, 18 robotic gastrectomies were performed from 31 December 2007 to 30 June 2008. The prospective data from gastric cancer patients who underwent gastrectomies (16 robotic, 11 laparoscopic, and 12 open) during the same period were retrospectively analyzed. Results: Sex, age, comorbidity, extent of lymphadenectomy, pT stage, lymph node metastasis, and number of lymph nodes retrieved were similar among the three groups. The estimated blood loss was significantly less in the robotic gastrectomy group than in the open group (p = 0.0312), and the postoperative hospital stay in the robotic group was significantly shorter than in the open and laparoscopic gastrectomy groups (p < 0.001). Postoperative morbidity and time to first flatus were similar in the three groups. There was no open or laparoscopic conversion in the robotic group. No postoperative mortality occurred in any group. Conclusion: Robotic gastrectomy for the treatment of gastric cancer is a feasible and safe procedure in the hands of experienced laparoscopic surgeons. Robotic gastrectomy offers better short-term surgical outcomes than the open and laparoscopic methods. Furthermore, this procedure may be a preferable alternative for the treatment of gastric cancer.
Anderson C. Pilot series of robot-assisted laparoscopic subtotal gastrectomy with extended lymphadenectomy for gastric cancer. Surg Endosc. 2007 Sep;21(9):1662-6.
Abstract
Robotic surgery is evolving as a therapeutic tool for thoracic and urologic applications; however, its use in gastric cancer surgery has not been extensively reported. The objective of this pilot series was to assess the feasibility of using robotic surgery in performing an extended lymphadenectomy for gastric cancer. METHODS: Between June 2005 and July 2006, seven patients (3 female, 4 male) underwent combined laparoscopic subtotal gastrectomy with omentectomy and robot-assisted extended lymphadenectomy using the da Vinci((R)) Surgical System for early distal gastric tumors. The mean age of the patients was 64 years. Tumor staging ranged from 0 to II. Six patients had adenocarcinoma and one patient had a high-grade dysplastic adenoma. RESULTS: All procedures were completed successfully without conversion. The median operating time was 420 min. There was one intraoperative complication requiring a colon resection for a devascularized segment. The median number of nodes harvested was 24 (range = 17-30). Resection margins were negative in all specimens. Patients were hospitalized a median of 4 days (range = 3-9). Thirty-day mortality was 0%. Patients resumed a solid diet a median of 4 days postoperatively. Median followup was 9 (range = 0-10) months. There have been no tumor recurrences to date. CONCLUSION: Extended lymphadenectomy for gastric cancer using robotic surgery is safe and allows for an adequate lymph node retrieval. Our preliminary results suggest that this novel technique offers short hospital stays and low morbidity for patients undergoing surgical resection of distal gastric malignancies. Future studies will be necessary to better define the role of robotic surgery in gastric cancer treatment.
Song J. Role of robotic gastrectomy using da Vinci system compared with laparoscopic gastrectomy: initial experience of 20 consecutive cases. Surg Endosc. 2009 June; pp. 1204-1211(8).
Abstract
Robotic surgery was invented to overcome the demerits of laparoscopic surgery. However, the role of robotic surgery in gastrectomy has rarely been reported. This study aimed to evaluate the use of robot-assisted distal subtotal gastrectomy to facilitate surgical training for gastric cancer. Methods: Twenty gastric cancer patients who underwent robotic gastrectomy from July 2005 to November 2006 were compared with 20 initial patients who underwent laparoscopic subtotal gastrectomy from May 2003 to August 2003 and 20 recent patients who underwent laparoscopic subtotal gastrectomy during the same period as the 20 robotic gastrectomy procedures by the same surgeon. Result: All 60 patients underwent subtotal gastrectomies with gastroduodenostomy without open or laparoscopic conversion. Operation time for robotic gastrectomy, initial laparoscopic gastrectomy, and recent laparoscopic gastrectomy was 230 min (range 171-312 min), 289.5 min (range 190-450 min), and 134.1 min (range 90-260 min). The number of retrieved lymph nodes was 35.3 ± 10.5, 31.5 ± 17.1, and 42.7 ± 14.9, respectively. Hospital stay was 5.7, 7.7, and 6.2 days, respectively. Postoperative complication occurred in two patients in recent laparoscopic gastrectomy and one patient each in robotic and initial laparoscopic gastrectomy. Conclusion: In this context, it could be assumed that experienced laparoscopic surgeons could perform robotic gastrectomy with a certain level of skill, even in initial series.
Giulianotti PC. Robotics in general surgery: personal experience in a large community hospital. Arch Surg. 2003;138:777-784.
Abstract
The study describes the clinical experience of the Department of General Surgery, Misericordia Hospital, Grosseto, Italy, in robot-assisted surgery using the da Vinci Surgical System. RESULTS: Between October 2000 and November 2002, 193 patients underwent a minimally invasive robotic procedure (74 men and 119 women; mean age, 55.9 years [range, 16-91 years]). A total of 207 robotic surgical operations, including abdominal, thoracic and vascular procedures, were performed; 179 were single procedures, and 14 were double (2 operations on the same patient). There were 4 conversions to open surgery and 3 to conventional laparoscopy (conversion rate, 3.6%; 7 of 193 patients). The perioperative morbidity rate was 9.3% (18 of 193 patients), and 6 patients (3.1%) required a reoperation. The postoperative mortality rate was 1.5% (3 of 193 patients). CONCLUSIONS: Our preliminary experience at a large community hospital suggests that robotic surgery is feasible in a clinical setting. Its daily use is safe and easily managed, and it expands the applications of minimally invasive surgery. However, the best indications still have to be defined, and the cost-benefit ratio must be evaluated. This report could serve as a basis for a future prospective, randomized trial.
While clinical studies support the effectiveness of the da Vinci Surgical System when used in minimally invasive surgery, individual results may vary. There are no guarantees of outcome. All surgeries involve the risk of major complications. Before you decide on surgery, discuss treatment options with your doctor. Understanding the risks of each treatment can help you make the best decision for your individual situation. Surgery with the da Vinci Surgical System may not be appropriate for every individual; it may not be applicable to your condition. Always ask your doctor about all treatment options, as well as their risks and benefits. Only your doctor can determine whether da Vinci Surgery is appropriate for your situation. The clinical information and opinions, including any inaccuracies expressed in this material by patients or doctors about da Vinci Surgery, are not necessarily those of Intuitive Surgical, Inc. and should not be considered as substitute for medical advice provided by your doctor. © 2010 Intuitive Surgical. All rights reserved.
PN 873871 Rev A 06/10
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