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- W2096359264 abstract "Laparoscopic gastrectomy is recommended for cStage IA gastric cancer not indicated for endoscopic treatment and cStage IB gastric cancer according to the Japanese Classification of Gastric Carcinoma (version 14). Strength of recommendation: B 1-1 For which gastric cancer stages is laparoscopic surgery indicated? Laparoscopic gastrectomy is indicated for cStage IA gastric cancer not indicated for endoscopic treatment and cStage IB gastric cancer in accordance with the Japanese Classification of Gastric Carcinoma (version 14). Explanation Meta-analyses 1-7, a review 8, small-scale randomized controlled trials (RCT) 9-11, a non-randomized study 12, and retrospective studies have shown that laparoscopic gastrectomy has superior short-term and comparable long-term outcomes to open gastrectomy 13-30. Many of the studies that compared laparoscopic surgery with open surgery have confined the indications for laparoscopic surgery to cT1 and cN0-1 cancer and have included only a limited number of patients with cStage ≥ II diseases. Studies that involved a relatively large number of patients with advanced cancer have also shown that laparoscopic surgery is comparable to open surgery in terms of short- and long-term postoperative outcomes 9, 12-15, 20, 23, 25, 29. However, a single small-scale RCT is the only study with a high level of evidence 9. Some retrospective studies are biased by background characteristics, including significantly smaller tumor sizes in the laparoscopic gastrectomy group 15, 20. A Japanese phase II clinical trial in patients with cStage ≤ IB (including SS, N0) gastric cancer, according to the Japanese Classification of Gastric Carcinoma (version 13), showed that laparoscopic gastrectomy could be performed safely with minimal risk of anastomotic insufficiency or pancreatic fistula, although most of the patients had stage IA cancer 31. Therefore, evidence is inadequate to recommend laparoscopic gastrectomy to patients with cStage ≥ II gastric cancers according to the Japanese Classification of Gastric Carcinoma (version 14). Furthermore, it should be noted that in this phase II clinical trial, laparoscopic gastrectomy was performed by surgeons with a high level of relevant experience. A high level of surgical experience in laparoscopic gastrectomy has been associated with a significantly low incidence of postoperative complications 32-35. Each institution should establish criteria for determining surgical indications by taking into account the surgeon's skill levels. 1-2 Are the short-term outcomes of laparoscopic gastrectomy superior to those of open gastrectomy? Laparoscopic gastrectomy is superior in terms of early postoperative recovery. Explanation Meta-analyses 1-7, a review 8, small-scale RCT 9-11, a non-randomized study 12, and retrospective studies have compared the short-term benefits of laparoscopic gastrectomy with those of open gastrectomy 14-24, 26-30. They demonstrated the superiority of laparoscopic surgery in terms of reduced blood loss 1-3, 5-8, 10, 15, 16, 18, 20, 21, 24, 27, 29, reduced dosing frequency and duration of analgesic therapy 4, 8, 19, 20, 22, 24, 27, reduced pain score 10, shorter duration of fever 9, earlier recovery of intestinal movement 2, 4, 6-8, 10, 20, 27, 30, earlier resumption of oral ingestion 6, 8, 20, 30, earlier recovery of walking function 6, 8, 10, 20, reduced incidence of postoperative complications 1, 3-5, 7, 11, 28-30, and shorter length of postoperative hospitalization 1, 2, 4, 5, 7, 8, 14, 16, 19, 21, 22, 24, 27, 30. Compared with open gastrectomy, laparoscopic gastrectomy has also been associated with significantly higher postoperative vital capacity 10; significantly lower peripheral white blood cell count, lymphocyte count, and serum C-reactive protein level; and significantly higher serum protein and albumin levels. These findings support the less invasiveness of laparoscopic gastrectomy 17, 22. 1-3 Are the long-term outcomes of laparoscopic gastrectomy inferior to those of open gastrectomy? For cStage I cancer, laparoscopic gastrectomy is likely to be comparable with open gastrectomy in terms of recurrence-free survival. Explanation A small-scale RCT 9, a non-randomized study 12, and nine retrospective studies have shown no significant difference in postoperative survival rate, recurrence rate, and mode of recurrence between laparoscopic and open gastrectomy (13, 19, 20, 23-25, 29, 30). Retrospective studies that used multivariate analysis have also demonstrated that prognosis is determined based on the depth of invasion and the extent of lymph node metastasis, but it is not affected by the selection of either a laparoscopic or open approach 23, 36. Evidence is insufficient to support the comparability of laparoscopic surgery with open surgery in terms of long-term outcomes, as the median observation period in most studies was shorter than 5 years and the prospective studies were conducted with small sample sizes 9, 12. Only a little evidence supports the recommendation of laparoscopic surgery for advanced or cStage ≥ II gastric cancer, as the available long-term outcomes were generated from retrospective studies with a limited sample size. 1-4 What are the intraoperative and postoperative complications that require special caution? Special attention should be paid to intraoperative bleeding. The profile of postoperative complications of laparoscopic gastrectomy is similar to that of open gastrectomy. Explanation Among the intraoperative complications of laparoscopic gastrectomy, special attention should be paid to intraoperative bleeding. Some case reports have described conversion to laparotomy during laparoscopic gastrectomy because of intraoperative bleeding 37, 38; therefore, countermeasures against intraoperative bleeding should be prepared. Meta-analyses 1-7, a review 8, small-scale RCT 9, 11, and a non-randomized study have identified no postoperative complications specific to laparoscopic gastrectomy 12. Therefore, even after laparoscopic gastrectomy, caution should be exercised with regard to the possible occurrence of anastomotic insufficiency, pancreatic fistula, intraperitoneal abscess, and anastomotic stenosis, which are relatively common after open gastrectomy. One report indicated that the incidence of pancreatic fistula requiring treatment after laparoscopic gastrectomy was similar to that after open gastrectomy, but the level of amylase in the abdominal drainage was significantly higher after laparoscopic surgery 18. Caution should be exercised while handling the energy device around the pancreas and while performing the procedure for compression of the pancreas to obtain a clear surgical field. Male sex and obesity have also been identified as risk factors for pancreatic fistula after laparoscopic gastrectomy 39. Reconstruction and anastomotic procedures after distal gastrectomy have also been reported to affect the type of postoperative complications 34, 40, suggesting that surgeons should select an anastomotic procedure with which they have adequate experience. 1-5 Which comorbidities or previous diseases require careful consideration when deciding whether laparoscopic gastrectomy should be indicated? Laparoscopic gastrectomy can be used even in elderly or obese patients as long as the surgeon's skill and experience allow. Explanation No meta-analysis or prospective study has been conducted regarding laparoscopic gastrectomy in patients with multiple comorbidities. Retrospective studies have investigated the outcomes of laparoscopic gastrectomy in gastric cancer patients with alarming comorbidities or previous diseases. The incidence of postoperative complications was similar between elderly and non-elderly patients 43-45, although the definition of elderly varied between studies. One study showed a significantly shorter operative time and smaller number of dissected lymph nodes in elderly patients 45, suggesting that the extent of lymph node dissection might be reduced in elderly patients. When BMI was used to distinguish between obese and non-obese patients, extended operative time and increased blood loss were reported in obese patients, with no significant difference in postoperative complications 46-48. Some studies that considered visceral fat area reported a significantly higher incidence of postoperative complications in the high-visceral fat area group 38, 42. In the Japanese phase II trial, patients with a BMI of 30 or higher were excluded from the study 31. Because laparoscopic gastrectomy in patients with visceral obesity is technically demanding, the surgeon's skill and experience should be taken into account when determining whether laparoscopic gastrectomy should be indicated. Among a limited number of reports on other comorbidities, one report showed no significant difference in the incidence of postoperative pulmonary complications between patients with chronic obstructive lung disease treated with laparoscopic surgery and patients treated with open surgery 49. Another study showed that the incidence of postoperative complications after laparoscopic gastrectomy in high-surgical risk patients with various comorbidities was comparable to that in low-surgical risk patients 50; in contrast, several other studies showed a significantly higher incidence of postoperative complications in patients with comorbidities 32, 35, 37, 43. The indications for laparoscopic gastrectomy in patients with multiple severe comorbidities should be determined carefully depending on the situation (e.g. in terms of scale, capacity, and performance) of each institution. Ichiro Uyama, Division of Upper GI, Deprtment of Surgery, Fujita Health University; Hiroshi Okabe, Division of Gastrointestinal Surgery, Department of Surgery, Kyoto University Hospital; Kazuyuki Kojima, Center for Minimally Invasive Surgery, Tokyo Medical and Dental University; Seiji Satoh, Department of Surgery, Himeji Medical Center; Norio Shiraishi, Center for Community Medicine, Oita University Faculty of Medicine; Shuji Takiguchi, Department of Gastroenterological Surgery, Osaka University; Eishi Nagai, Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University; Tetsu Fukunaga, Department of Surgery, Juntendo University Urayasu Hospital. Laparoscopic surgery may be considered for cStage IA-IB gastric cancer, but scientific evidence is insufficient to support this recommendation. 2-1 For which gastric cancer stages is laparoscopic surgery indicated? Laparoscopic surgery is indicated for cStage IA-IB gastric cancer according to the Japanese Classification of Gastric Carcinoma (version 14). Explanation Thus far, nine comparative case studies of open and laparoscopic total gastrectomy have been published, including subset analyses as part of studies that compared general gastrectomy procedures 1-9. Each of these studies involved a relatively large number of patients (n < 100) who had undergone laparoscopic total gastrectomy. Five of these studies conducted in Japan and South Korea included only patients with early-stage cancer 1, 2, 6, 8, 9. The remaining four studies were conducted outside Japan, and patient eligibility was not limited to those with early-stage cancer; most patients had advanced cancer 3-5, 7. In all the studies, laparoscopic surgery was associated with a similar number of lymph node dissections, longer surgical time, less intraoperative blood loss, and similar or lower incidence of complications compared with open surgery. Among case series reports, many of those from Japan included only early-stage cancers, or T2 or lower cancers 10, whereas many of those from outside Japan were not limited in terms of the degree of disease progression; one case series involved stage IV patients undergoing palliative total gastrectomy 11. However, it should be noted that issues such as #10 lymph node dissection during D2 resection for advanced cancer, simultaneous splenectomy, and omentectomy have only been discussed in a few reports from Japan 12. 2-2 Is there evidence that laparoscopic surgery is superior to open surgery? Laparoscopic total gastrectomy performed by an experienced surgeon may result in better short-term outcomes than open surgery. Explanation No dedicated prospective study has been conducted to compare the short-term outcomes of laparoscopic total gastrectomy with those of open total gastrectomy. Meanwhile, nine retrospective case–control studies have shown that laparoscopic total gastrectomy is associated with extended surgical time but less intraoperative blood loss compared with open total gastrectomy 1-9. Laparoscopic surgery has also been associated with lower increases in postoperative white blood cell count and C-reactive protein level 1, 2, 8, less postoperative pain 2, 3, 8, and earlier recovery of intestinal movement 1, 3. These data are based on single-center retrospective studies conducted in leading institutions in laparoscopic gastrectomy, where surgeons have sufficient experience with laparoscopic surgery. Drawing general conclusions on the superiority of laparoscopic surgery to laparotomy from these data is therefore inappropriate. 2-3 Are the long-term outcomes of laparoscopic surgery inferior to those of open surgery? No evidence supports the comparability of laparoscopic and open total gastrectomy in terms of long-term outcomes. Explanation Nine comparative studies of open and laparoscopic total gastrectomy have been published, including subset analyses 1-9. Most of the studies evaluated the general prognosis after laparoscopic gastrectomy, except for two studies that compared prognosis only in patients who had undergone total gastrectomy. In one of the studies, which followed up 100 patients who had undergone laparoscopic total gastrectomy (stage I) and 348 case-matched patients who had undergone laparotomy for 52.6 months, the 5-year survival rates were 95% and 87.6% with laparoscopic and open surgery, respectively. In another study, which included 82 patients who had undergone laparoscopic surgery and 94 patients who had undergone laparotomy, no significant difference was found in recurrence rate (19/82 vs 23/94, respectively) 3. Among case series reports that compared prognosis, many of the reports from Japan included only patients with early-stage gastric cancer and showed no significant differences in prognosis 10, 13. In one Japanese study that examined the prognosis of 55 patients who were followed-up for a median duration of 16 months after total gastrectomy for advanced gastric cancer, 44 patients achieved recurrence-free survival, 2 developed recurrence, and 8 died 12. In another study of 209 patients who had undergone laparoscopic surgery for advanced gastric cancer, including 59 patients who had undergone total gastrectomy, the 5-year survival rates of patients with stage IB, II, IIIA, and IIIB cancer were 89.1%, 93.1%, 52.5%, and 46.5%, respectively. The recurrence in 27 patients included peritoneal dissemination in 13 patients and liver metastasis in 7 patients, with no atypical mode of recurrence, such as port-site recurrence 14. 2-4 Which intraoperative or postoperative complications require special caution? Intraoperative complications that require special caution include bleeding and organ damage, and postoperative complications include anastomotic insufficiency, anastomotic stenosis, pancreatic fistula, postoperative bleeding, and intraperitoneal abscess. Explanation Nine comparative case studies have been conducted on laparoscopic total gastrectomy 1-9. One of these studies compared 100 patients with early-stage cancer who had undergone laparoscopic total gastrectomy and 348 case-matched patients who had undergone open total gastrectomy 9. The complication rate was 27% with laparoscopic surgery and 23.6% with laparotomy, with no significant difference. Many other reports have also concluded that the complication rate of laparoscopic surgery is generally comparable with that of open surgery. The complication rates in six studies involving a series of at least 50 patients who had undergone laparoscopic total gastrectomy ranged from 10.9% to 33%. The difference in complication rates seems to relate to the unclear criteria for complications and the relatively small sample sizes. 2-5 Which comorbidities or previous diseases require careful consideration as indications for laparoscopic surgery? No evidence has been found to determine the indications for laparoscopic total gastrectomy based on comorbid diseases or patients' medical history. For patients with advanced age or obesity, the indications for laparoscopic total gastrectomy should be determined by taking into account the surgeon's skill and experience, as is the case with distal gastrectomy. Explanation Compared with laparoscopic distal gastrectomy, laparoscopic total gastrectomy is more technically demanding. Therefore, the outcomes of laparoscopic total gastrectomy are more likely to be affected by comorbid diseases and the patient's medical history. None of the studies that focused on laparoscopic total gastrectomy has addressed history of laparotomy or comorbid diseases such as high visceral fat volume, advanced age, diabetes, and heart disease in a sufficient number of patients. In obese patients, laparoscopic distal gastrectomy has also been associated with increased blood loss and extended surgical time because of excessive visceral fat 17-20. Given that total gastrectomy requires a wider operative field and is associated with increased difficulty in completing reconstruction, surgical indications in these patients should be determined carefully. The low invasiveness of laparoscopic surgery is thought to be beneficial for elderly and high-risk patients. Several studies have shown a significantly high incidence of postoperative complications after laparoscopic gastrectomy 21-24. Given that the surgical time is likely to be extended in laparoscopic total gastrectomy, the indications for the technique in patients with severe comorbid diseases should be determined carefully in each institution. Ichiro Uyama, Division of Upper GI, Deprtment of Surgery, Fujita Health University; Hiroshi Okabe, Division of Gastrointestinal Surgery, Department of Surgery, Kyoto University Hospital; Kazuyuki Kojima, Center for Minimally Invasive Surgery, Tokyo Medical and Dental University; Seiji Satoh, Department of Surgery, Himeji Medical Center; Norio Shiraishi, Center for Community Medicine, Oita University Faculty of Medicine; Shuji Takiguchi, Department of Gastroenterological Surgery, Osaka University; Eishi Nagai, Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University; Tetsu Fukunaga, Department of Surgery, Juntendo University Urayasu Hospital. Laparoscopic surgery may be considered, but scientific evidence is insufficient to support this recommendation. 3-1 For what disease status is laparoscopic surgery indicated? Laparoscopic local gastrectomy may be considered for treating gastrointestinal stromal tumors (GIST) no greater than 5 cm in diameter, as long as the surgery is performed by an experienced endoscopic surgeon. Explanation No clear evidence of level III or higher defines the type of GIST for which laparoscopic local gastrectomy is recommended. A retrospective study demonstrated that laparoscopic local gastrectomy can be safely performed if the tumor size is no greater than 5 cm in diameter 1. Another retrospective study that categorized patients according to tumor size, with a 2 cm diameter being the cut-off, showed that although extended surgical time and hospitalization were observed in the group of patients with tumors larger than 2 cm, laparoscopic local gastrectomy could be performed safely in both groups, with no postoperative recurrence or metastasis 2. The Japanese Clinical Practice Guidelines for GIST (version 2 supplement) state that a surgeon performing laparoscopic local gastrectomy for gastric GIST should never directly hold the tumor with forceps or other devices. 3-2 Are the short-term outcomes of laparoscopic surgery superior to those of open surgery? Laparoscopic local gastrectomy may be superior to open surgery in terms of short-term outcomes. Explanation No RCT has been conducted to compare the short-term outcomes of laparoscopic local gastrectomy and those of open surgery for the treatment of gastric GIST 3. A report indicated that laparoscopic surgery was associated with less blood loss than laparotomy for the surgical treatment of gastric GIST, whereas another report showed no significant difference in blood loss between the two techniques 4, 5. Both reports showed no significant difference in surgical time 4, 5. A significantly shorter length of hospitalization after laparoscopic surgery was described in three reports 3, 5, 6. Also, patients with gastric GIST that were 8 cm or less in diameter had significantly shorter hospitalization periods 6. 3-3 Are the long-term outcomes of laparoscopic surgery inferior to those of open surgery? No evidence has been found to support the comparability of laparoscopic local gastrectomy and open surgery in terms of long-term outcomes. Explanation No RCT has been conducted to compare the long-term outcomes of laparoscopic local gastrectomy and those of open surgery for the treatment of gastric GIST. The only study that reported on the long-term outcomes, after a median follow-up period of 26 months, showed comparable long-term outcomes between laparoscopic local gastrectomy and open surgery 4. Another report showed a significantly lower recurrence rate in the laparoscopic surgery group than in the open surgery group, although an imbalance was observed between the two groups with respect to the pathological characteristics of the primary lesions of the gastric GIST 7. 3-4 Have intraoperative and postoperative complications in laparoscopic local gastrectomy that require special caution, compared with open surgery, been reported? No intraoperative or postoperative complications of laparoscopic local gastrectomy that require special caution compared with open surgery have been reported. Explanation No study of evidence level III or higher has been conducted to compare the incidence of intraoperative and postoperative complications of laparoscopic local gastrectomy with those of open surgery. The intraoperative and postoperative complications reported include conversion from laparoscopy to open surgery because of technical difficulty in completing the resection and reconstruction 8, as well as postoperative bleeding 2. 3-5 Which comorbidities or previous diseases require careful consideration as indications for laparoscopic surgery? No particular comorbidities or medical histories have been identified for which the indications for laparoscopic local gastrectomy should be more carefully considered than for open surgery. Explanation No study of evidence level III or higher has discussed comorbid diseases or patients' medical histories requiring special attention when laparoscopic local gastrectomy for gastric GIST is indicated. However, several small-scale studies have suggested that laparoscopic surgery can be more safely performed with a shorter length of hospitalization than open surgery 3, 7, 8, 11, 12. Ichiro Uyama, Division of Upper GI, Deprtment of Surgery, Fujita Health University; Hiroshi Okabe, Division of Gastrointestinal Surgery, Department of Surgery, Kyoto University Hospital; Kazuyuki Kojima, Center for Minimally Invasive Surgery, Tokyo Medical and Dental University; Seiji Satoh, Department of Surgery, Himeji Medical Center; Norio Shiraishi, Center for Community Medicine, Oita University Faculty of Medicine; Shuji Takiguchi, Department of Gastroenterological Surgery, Osaka University; Eishi Nagai, Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University; Tetsu Fukunaga, Department of Surgery, Juntendo University Urayasu Hospital. Laparoscopic suture of gastric/duodenal perforated ulcer may be recommended for patients with low preoperative risk. 4-1 For which patients is laparoscopic surgery indicated? Laparoscopic surgery is recommended for patients with no preoperative risk. Explanation Recent meta-analyses have shown that laparoscopic surgery is beneficial to patients with no preoperative risk 1, 2. However, no clear evidence supports the benefit of laparoscopic surgery to patients at risk (e.g. those in whom perforation occurred more than 24 h earlier; those in shock, with a systolic blood pressure of 90 mmHg or lower on admission; and those with systemic disease corresponding to an ASA score of III/IV). A cohort study showed the benefit of laparoscopic surgery in high-risk patients 3, and a prospective randomized study demonstrated the benefit of laparoscopic surgery in a population including patients with severe illnesses 4. The eligibility criteria in these studies included adequate informed consent, but the actual enrollment of patients with severe illnesses was limited because of the difficulty in obtaining informed consent from these patients. Therefore, clear evidence is lacking to support the benefit of laparoscopic surgery in high-risk patients. 4-2 Are the short-term outcomes of laparoscopic surgery superior to those of open surgery? Laparoscopic surgery is superior to open surgery in terms of reduced postoperative wound pain, reduced analgesic use, and shorter length of hospitalization. At the same time, laparoscopic surgery has been associated with an increased incidence of postoperative suture insufficiency. Explanation Laparoscopic surgery has been associated with reduced postoperative wound pain and analgesic use compared with open surgery 1, 2, 7, 8. A significantly lower incidence of wound infection after laparoscopic surgery (odds ratio: 0.39) was also reported 1, 2. An RCT conducted by Siu et al. showed a significant decrease in the incidence of postoperative pneumonia in laparoscopically treated patients 9. However, meta-analyses have shown no significant difference in the incidence of postoperative pneumonia, although a slightly lower incidence was found with laparoscopic surgery (2.3%) than with open surgery (3.2%; odds ratio: 0.79) 1, 2. Additionally, no significant difference has been found in the incidence of postoperative intraperitoneal abscess 1, 2. Laparoscopic surgery has been associated with a significantly higher incidence of suture insufficiency (6.9%) than open surgery 1. Mortality rate was correlated with the Acute Physiology and Chronic Health Evaluation II score (≥ 6), but not with surgical procedures (open or laparoscopic surgery) 7. 4-3 Are the long-term outcomes of laparoscopic surgery inferior to those of open surgery? Laparoscopic surgery may be superior to open surgery in terms of a lower incidence of postoperative ileus. Explanation 4-4 Have intraoperative and postoperative complications in laparoscopic surgery that require special caution, compared with open surgery, been reported? Laparoscopic surgery has been associated with a higher incidence of suture insufficiency than open surgery. Explanation Laparoscopic surgery has been associated with a significantly higher incidence of suture insufficiency (6.9%) than open surgery 1. The reoperation rate is also higher with laparoscopic surgery (odds ratio: 2.52), the major cause of which is suture insufficiency 2. 4-5 Which comorbidities or previous diseases require careful consideration as indications for laparoscopic surgery? The indications for laparoscopic surgery should be carefully considered in systemic conditions that may increase the Boey score. Explanation Previous prospective studies have excluded patients with hemorrhagic ulcer, obstruction, major perforation, technically complicated cases, history of upper abdominal surgery 9, 10, long-term steroid use, and poorly controlled diabetes from indications for laparoscopic surgery 11. However, there is no clear evidence to support the exclusion of these conditions from the indications for laparoscopic surgery. The rate of conversion from laparoscopic to open surgery has been reported to be 0%–29.1% 12. The causes of conversion include, but are not limited to, unidentified perforation site, large perforation size, perforation/penetration of the posterior wall, severe adhesion, and unstable cardiopulmonary conditions 13. Given these findings, laparoscopic surgery is reportedly not beneficial for patients in a state of shock 13. A higher Boey score has been suggested to be associated with a high rate of conversion to laparotomy 7 (see CQ 4-4). Therefore, the indications for laparoscopic surgery should be carefully considered in systemic conditions that may increase the Boey score. Ichiro Uyama, Division of Upper GI, Deprtment of Surgery, Fujita Health University; Hiroshi Okabe, Division of Gastrointestinal Surgery, Department of Surgery, Kyoto University Hospital; Kazuyuki Kojima, Center for Minimally Invasive Surgery, Tokyo Medical and Dental University; Seiji Satoh, Department of Surgery, Himeji Medical Center; Norio Shiraishi, Center for Community Medicine, Oita University Faculty of Medicine; Shuji Takiguchi, Department of Gastroenterological Surgery, Osaka University; Eishi Nagai, Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University; Tetsu Fukunaga, Department of Surgery, Juntendo University Urayasu Hospital." @default.
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