Short-Term Outcomes from a Randomized Screening Phase II Non-inferiority Trial Comparing Omentectomy and Omentum Preservation for Locally Advanced Gastric Cancer: the TOP-G Trial.

BACKGROUND: Omentectomy is considered an essential part of curative gastrectomy for locally advanced gastric cancer (GC), albeit without solid evidence. We conducted a randomized phase II trial (the TOP-G trial) comparing omentectomy and omentum preservation for gastric cancer. This report describes the short-term findings regarding the trial's secondary endpoints. METHODS: The trial protocol was submitted to the University Hospital Medical Information Network Clinical Trials Registry ( http://www.umin.ac.jp/ctr/ : UMIN000005421). The key eligibility criteria were histologically confirmed cT2-4a and N0-2 gastric adenocarcinoma. Short-term surgical outcomes, including morbidity and mortality, were compared between the omentectomy group (group A, control arm) and the omentum-preserving surgery group (group B, test arm). All procedures were performed via an open approach. Based on a non-inferiority margin of 7%, statistical power of 0.7, and type I error of 0.2, the sample size was set to 250 patients. RESULTS: A total of 251 patients were eligible and randomized (group A: 125 patients, group B: 126 patients) between April 2011 and October 2018. After excluding patients who had peritoneal metastasis or laparotomy history, safety outcomes were analyzed for 247 patients. Group A had a significantly longer median operation time (225 min vs. 204 min, p = 0.022) and tended to have greater median blood loss (260 mL vs. 210 mL p = 0.073). The incidences of morbidity were similar and < 10% in both groups (8% vs. 9%, p = 1.000). There was no mortality in either group. CONCLUSIONS: Operative risk was generally similar between omentectomy and omentum-preserving surgery for locally advanced gastric cancer.

Theoretical therapeutic impact of lymph node dissection on adenocarcinoma and squamous cell carcinoma of the esophagogastric junction.

BACKGROUNDS: The aim of this study was to evaluate the theoretical therapeutic impact of dissecting each lymph node station for adenocarcinoma and squamous cell carcinoma of the esophagogastric junction. METHODS: This multicenter study included 431 junctional cancer patients (381 adenocarcinomas and 50 squamous cell carcinomas) who fulfilled the following criteria: (1) the center of the tumor was located between 1 cm above and 2 cm below the esophagogastric junction, and (2) the tumor invaded the junction. The theoretical therapeutic impact of dissecting each lymph node station was evaluated based on the therapeutic value index calculated by multiplying the frequency of metastasis to each station and the 5-year survival rate of patients with metastasis to that station. RESULTS: The 5-year overall survival rates (95% confidence interval) were 60.4% (55.1-65.7) in the adenocarcinoma cases and 52.3% (35.6-69.0) in the squamous cell carcinoma cases. The nodal stations showing the first to fifth highest index were the paracardial and lesser curvature nodes (nos. 1, 2 and 3), nodes at the root of the left gastric artery (no. 7) and lower mediastinal lymph nodes, regardless of the histology. CONCLUSIONS: Nodal dissection achieved by proximal gastrectomy and lower esophagectomy should be the minimal requirement for junctional cancer regardless of the histology, considering the therapeutic value indices for the relevant lymph node stations.

Impact of infectious complications on gastric cancer recurrence.

BACKGROUND: Postoperative infectious complications increase disease recurrence in colorectal cancer patients. We herein investigated the impact of infectious complications on gastric cancer recurrence after curative surgery. METHODS: In total, 502 patients who underwent R0 resection for gastric cancer were reviewed. Patients were classified into those with infectious complications (IC group) and those without infectious complications (NO group). The risk factors for recurrence-free survival (RFS) were identified. RESULTS: Infectious complications, which occurred in 52 patients (10.4%), included pneumonia, ileus with a systemic inflammatory reaction, anastomotic leakage, and intraperitoneal abscess. The overall 5-year RFS rate was 83% in the NO group and 58% in the IC group (p = 0.000). Multivariate analysis demonstrated that age, ASA score, stage, and infectious complications were significant predictors of RFS. CONCLUSIONS: Infectious complications were a risk factor for gastric cancer recurrence. To avoid causing infectious complications, the surgical procedure, surgical strategy, and perioperative care should be carefully planned.

Is the canal flare index a reliable means of estimation of canal shape? Measurement of proximal femoral geometry by use of 3D models of the femur.

BACKGROUND: The canal flare index (CFI; the ratio of the diameter of the femoral canal at the isthmus in the anteroposterior (A-P) view to the diameter of the medullary canal 20 mm above the lesser trochanter) is often used as a canal characteristic. Clinically, however, CFI measurements are sometimes untrustworthy because of femoral rotation and, especially, greater anteversion among Japanese patients. Our objectives were to analyze femoral geometry, by use of 3D CAD models, to evaluate the effects of rotational error, and to seek an index less affected by rotation. METHODS: Computed axial tomography (CAT) scan data from 60 femurs were used. By use of CAD software, 3D femoral models were created. The outside of the femur and the inside canal width 20 mm (P20) and 10 mm proximal (P10), and 10 mm (D10), 20 mm (D20), 30 mm (D30), and 40 mm (D40) distal from the center of the lesser trochanter, and at the isthmus were measured for different angles of femoral rotation. CFI, FFI (femoral flare index; the ratio of the extra-cortical diameters at the same levels as for the CFI), and other canal ratios (P20/D10, P20/D20, P20/D30, and P20/D40) were then calculated and the effect of rotational errors was investigated. RESULTS: Mean CFI, FFI, P20/D10, P20/D20, P20/D30, and P20/D40 were 4.29, 2.08, 2.05, 2.49, 2.85, and 3.09 in the position without rotational error. CFI was not related to anteversion but had a negative correlation with isthmus canal width (only). In contrast FFI was almost constant at approximately 2.1 for different anteversion and age. With regard to the effect of rotational error, CFI changed by 1.31, FFI by 0.40, P20/D10 by 0.41, P20/D20 by 0.40, P20/D30 by 0.59, and P20/D40 by 0.80 for a variety of rotational angles. CONCLUSIONS: Outside femoral shape was little different for any person; as a result, FFI was almost constant. In contrast, CFI was revealed to be affected by canal width at the isthmus only. With regard to the effect of rotation, P20/D20 was much less affected by rotation than CFI; it could, therefore, be an appropriate index for expressing proximal canal shape.

[A case of stage IV gastric cancer resected after chemotherapy with capecitabine plus cisplatin].

A 64-year-old woman was diagnosed with Stage IV gastric cancer with lymph node and multiple liver metastases. She was treated with 6 courses of chemotherapy, in 3-week courses, with capecitabine (1,000 mg/m/(2)) plus cisplatin(80 mg/m(2)) administered for 2 weeks, followed by a drug-free week. She underwent curative total gastrectomy with D2 lymph node dissection and reconstruction by using the Roux-en-Y method. The postoperative pathological findings revealed a T3 (SE), N1M1, Stage II B tumor; the tumor was determined to be Grade 1b owing to the chemotherapeutic effect. Postoperatively, only S-1 therapy was administered, because of the development of Grade 3 hand-foot syndrome. The patient is alive 1 year and 8 months after the initial gastrectomy.

Accuracy of CT staging of locally advanced gastric cancer after neoadjuvant chemotherapy: cohort evaluation within a randomized phase II study.

BACKGROUND: Accuracy of the radiologic diagnosis of gastric cancer staging after neoadjuvant chemotherapy remains unclear. METHODS: Patients enrolled in the COMPASS trial, a randomized phase II study comparing two and four courses of S-1 plus cisplatin and paclitaxel and cisplatin followed by gastrectomy, were examined. The radiologic stage was determined by using thin-slice computed tomography (CT) or multidetector low CT by following Habermann's method. RESULTS: A total of 75 patients registered in the COMPASS study who underwent surgical resection were examined in this study. The radiologic T and pathologic T stages were not significantly correlated (p = 0.221). The radiologic accuracy and rates of underdiagnosis and overdiagnosis were 42.7, 10.7, and 46.7%, respectively. When patients were stratified according to the pathologic response of the primary tumor, the correlation was not significant in either the responders (n = 32, p = 0.410) or the nonresponders (n = 43, p = 0.742). The radiologic accuracy was 37.5% in the responders and 42.7% in the nonresponders. The radiologic N and pathologic N stages were significantly correlated (p = 0.000). The radiologic accuracy and rates of underdiagnosis and overdiagnosis were 44, 29.3, and 26.7%, respectively. When stratifying the patients with measurable lymph nodes according only to the radiologic response, the correlation was significant in the nonresponders (n = 23, p = 0.035) but not in the responders (n = 28, p = 0.634). The radiologic accuracy was 39.3% in the responders and 52.1% in the nonresponders. CONCLUSIONS: Restaging using CT after neoadjuvant chemotherapy for gastric cancer is considered to be inaccurate and unreliable. In particular, the radiologic T-staging determined after neoadjuvant chemotherapy should not be considered in clinical decision-making.

Randomized comparison of surgical stress and the nutritional status between laparoscopy-assisted and open distal gastrectomy for gastric cancer.

BACKGROUND: Laparoscopy-assisted distal gastrectomy (LADG) for gastric cancer may prevent the development of an impaired nutritional status due to reduced surgical stress compared with open distal gastrectomy (ODG). METHODS: This study was performed as an exploratory analysis of a phase III trial comparing LADG and ODG for stage I gastric cancer during the period between May and December of 2011. All patients received the same perioperative care via fast-track surgery. The level of surgical stress was evaluated based on the white blood cell count and the interleukin-6 (IL-6) level. The nutritional status was measured according to the total body weight, amount of lean body mass, lymphocyte count, and prealbumin level. RESULTS: Twenty-six patients were randomized to receive ODG (13 patients) or LADG (13 patients). The baseline characteristics and surgical outcomes were similar between the two groups. The median IL-6 level increased from 0.8 to 36.3 pg/dl in the ODG group and from 1.5 to 53.3 pg/dl in the LADG group. The median amount of lean body mass decreased from 48.3 to 46.8 kg in the ODG group and from 46.6 to 46.0 kg in the LADG group. There are no significant differences between two groups. CONCLUSIONS: The level of surgical stress and the nutritional status were found to be similar between the ODG and LADG groups in a randomized comparison using the same perioperative care of fast-track surgery.

A prospective randomized controlled trial of subcutaneous passive drainage for the prevention of superficial surgical site infections in open and laparoscopic colorectal surgery.

INTRODUCTION: A number of studies have evaluated the effects of subcutaneous drainage during digestive surgery. All of the previous studies assessed the usefulness of active-suctioning drain, including two randomized controlled studies which found no benefit for the placement of active-suctioning drains in digestive surgery. The utility of passive drainage has not been evaluated previously. The purpose of this study was to evaluate the efficacy of subcutaneous passive drainage system for preventing surgical site infections during major colorectal surgery. PATIENTS AND METHODS: A total of 263 patients who underwent major colorectal surgery were enrolled in this study. Patients were randomly assigned to receive subcutaneous passive drainage or no drainage. The primary outcome measured was the incidence of superficial surgical site infections. The secondary outcomes measured were the development of hematomas, seromas, and wound dehiscence. RESULTS: Finally, a total of 246 patients (124 underwent passive drainage, and 122 underwent no drainage) were included in the analysis after randomization. There was a significant difference in the incidence of superficial surgical site infections between patients assigned to the passive drainage and no drainage groups (3.2 % vs 9.8 %, respectively, P = 0.041). There were no cases that developed a hematoma, seroma, or wound dehiscence in either group. A subgroup analysis revealed that male gender, age ≥75 years, diabetes mellitus, American Society of Anesthesiologists (ASA) status ≥2, blood loss ≥100 ml, and open access were factors that were associated with a beneficial effect of subcutaneous passive drainage. CONCLUSIONS: Subcutaneous passive drainage provides benefits over no drainage in patients undergoing major colorectal surgery.

Vitamin E deficiency begins within 6 months after gastrectomy for gastric cancer.

BACKGROUND: To clarify factors related to vitamin E malabsorption after gastric surgery, we evaluated serum vitamin E levels in patients who had undergone gastrectomy for gastric cancer. METHODS: We studied 39 patients (26 men, 13 women; mean age, 61.7 years) who underwent gastrectomy for early gastric cancer. Surgical procedures included 24 subtotal gastrectomies and 15 total gastrectomies. We measured serum levels of vitamin E before and 3, 6, 9, and 12 months after gastrectomy. A level of less than 0.75 mg/dl was defined as a low vitamin E level. RESULTS: Serum vitamin E levels decreased to less than 0.75 mg/dl in 6 (15.4%) of the 39 patients within 6 months after gastrectomy and in 7 (17.9%) of the 39 patients within 1 year after gastrectomy. The proportion of patients with a low serum vitamin E level was significantly higher in the total gastrectomy group (p = 0.002). A low vitamin E level was significantly associated with a low total cholesterol level. Total cholesterol levels in low vitamin E levels patients were lower than normal vitamin E levels patients. None of the patients with a low vitamin E level had neuropathy. CONCLUSIONS: The type of operation performed (total vs. subtotal gastrectomy) may be the major cause of vitamin E malabsorption after gastrectomy for gastric cancer. Vitamin E deficiency probably begins within 6 months after gastrectomy for gastric cancer.

Visualization of blood supply route to the reconstructed stomach by indocyanine green fluorescence imaging during esophagectomy.

BACKGROUND: Ensuring an adequate blood supply is essential to the safe performance of an anastomosis during esophagectomy and the prevention of anastomotic leakage. Recently, indocyanine green (ICG) fluorescence imaging has been used to visualize the blood supply when anastomosis is performed in vascular surgery. We used ICG fluorescence imaging to visualize the blood supply for reconstruction during esophagectomy. METHODS: Since January 2009, we have performed ICG fluorescence imaging in 33 patients with thoracic esophageal cancer who underwent thoracic esophagectomy. After pulling up the reconstructed stomach, 2.5 mg of ICG was injected as a bolus. ICG fluorescence imaging was performed with a near-infrared camera, and the images were recorded. RESULTS: ICG fluorescence was easily detected in all patients 1 min after injection. Vascular networks were well visualized in the gastric wall and omentum. The blood supply route was located in the greater omentum beside the splenic hilum in 22 (66.7%) of the 33 patients. CONCLUSIONS: ICG fluorescence can be used to evaluate the blood supply to the reconstructed stomach in patients undergoing esophagectomy for esophageal cancer. On ICG fluorescence imaging, the splenic hiatal vessels were the major blood supply for the anastomosis in most patients.

Long-Term (>10 Years) clinical outcomes of first-in-human biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai stents.

BACKGROUND: The purpose of this study was to evaluate the long-term safety of the Igaki-Tamai stent, the first-in-human fully biodegradable coronary stent made of poly-l-lactic acid. METHODS AND RESULTS: Between September 1998 and April 2000, 50 patients with 63 lesions were treated electively with 84 Igaki-Tamai stents. Overall clinical follow-up (>10 years) of major adverse cardiac events and rates of scaffold thrombosis was analyzed together with the results of angiography and intravascular ultrasound. Major adverse cardiac events included all-cause death, nonfatal myocardial infarction, and target lesion revascularization/target vessel revascularization. During the overall clinical follow-up period (121 ± 17 months), 2 patients were lost to follow-up. There were 1 cardiac death, 6 noncardiac deaths, and 4 myocardial infarctions. Survival rates free of all-cause death, cardiac death, and major adverse cardiac events at 10 years were 87%, 98%, and 50%, respectively. The cumulative rates of target lesion revascularization (target vessel revascularization) were 16% (16%) at 1 year, 18% (22%) at 5 years, and 28% (38%) at 10 years. Two definite scaffold thromboses (1 subacute, 1 very late) were recorded. The latter case was related to a sirolimus-eluting stent, which was implanted for a lesion proximal to an Igaki-Tamai stent. From the analysis of intravascular ultrasound data, the stent struts mostly disappeared within 3 years. The external elastic membrane area and stent area did not change. CONCLUSION: Acceptable major adverse cardiac events and scaffold thrombosis rates without stent recoil and vessel remodeling suggested the long-term safety of the Igaki-Tamai stent.

Esophagus or stomach? The seventh TNM classification for Siewert type II/III junctional adenocarcinoma.

BACKGROUND: The aim of this study is to clarify whether TNM-EC or TNM-GC is better for classifying patients with AEG types II/III. METHODS: The patients who had AEG types II/III and received D1 or more radical lymphadenectomy were selected. The patients were staged both by seventh edition of TNM-EC and TNM-GC. The distribution of the patients, the hazard ratio (HR) of each stage, and the separation of the survival were compared. RESULTS: A total of 163 patients were enrolled in this study. TNM-EC and TNM-GC classified 25 (20 and 5) and 32 (20 and 12) patients to stage I (IA and IB), 15 (4 and 11), and 33 (11 and 22) to stage II (IIA and IIB), 88 (24, 3, and 61) and 63 (14, 26, and 23) to stage III (IIIA, IIIB, and IIIC), and 35 and 35 to stage IV, respectively. The distribution of the patients was substantially deviated to stage IIIC in TNM-EC but was almost even in TNM-GC. A stepwise increase of HR was observed in TNM-GC, but not in TNM-EC. The survival curves between stages II and III were significantly separated in TNM-GC (P = 0.019), but not in TNM-EC (P = 0.204). The 5-year survival rates of stages IIIA, IIIB, and IIIC were 69.0, 100, and 38.9% in TNM-EC and were 52.0, 43.4, and 33.9% in TNM-GC, respectively. CONCLUSIONS: TNM-GC is better for classifying patients with AEG types II/III than TNM-EC is. These results could impact the next TNM revision for AEG.

A prospective validation study to diagnose serosal invasion and nodal metastases of gastric cancer by multidetector-row CT.

BACKGROUND: Multidetector-row CT (MDCT) may provide accurate preoperative staging of resectable gastric cancer. However, the standard methods and criteria to diagnose the T and N stages to select the patients who are good candidates for neoadjuvant chemotherapy have not been established yet. METHODS: The aim of this prospective study was to evaluate the accuracy of MDCT to diagnose the serosal invasion and nodal metastases of gastric cancer. Patients who had gastric adenocarcinoma underwent MDCT scanning using a standardized method. The T and N stage were diagnosed by prespecified criteria. The analyses were performed in the patients who had cN0-2 and M0 tumors and underwent curative gastrectomy as a primary treatment. The accuracy was calculated by comparing the results of MDCT with the histopathological findings. RESULTS: A total of 315 patients were analyzed. The overall diagnostic accuracy (95 % confidence interval) of T staging was 71.4 % (225 of 315, 66.2-76.1). The accuracy, sensitivity, and specificity for serosal invasion were 85.7 % (81.4-89.1), 54.5 % (42.6-66.0), and 94.0 % (90.3-96.3), respectively. The false-positive rate for serosal invasion was 6.0 % (2.9-7.7). The overall diagnostic accuracy of N staging was 75.9 % (239 of 315, 70.9-80.3). The accuracy, sensitivity, and specificity for nodal metastases were 81.3 % (76.6-85.2), 46.4 % (36.8-56.3), and 96.8 % (93.5-98.4), respectively. The false-positive rate for nodal metastases was 3.2 % (1.6-6.5 %). CONCLUSIONS: These results suggest that MDCT provides an accurate diagnosis with high specificity and a low false-positive rate and can be used to select the patients who are candidates for preoperative chemotherapy.

Body weight loss after surgery is an independent risk factor for continuation of S-1 adjuvant chemotherapy for gastric cancer.

BACKGROUND: Compliance of S-1 adjuvant chemotherapy is not high. The aim of the present study is to clarify risk factors for continuation of S-1 after gastrectomy. METHODS: This retrospective study selected patients who underwent curative D2 surgery for gastric cancer, were diagnosed with stage 2/3 disease, creatinine clearance more than 60 ml/min, and received adjuvant S-1 at our institution between June of 2002 and December of 2011. Time to S-1 treatment failure (TTF) was calculated. RESULTS: A total of 103 patients were selected for the present study. When TTF curve stratified by each clinical factor was compared by the log-rank test, body weight loss (BWL) of 15 % was regarded as a critical point. Both univariate and multivariate Cox proportional hazard analyses demonstrated that BWL was the significant independent risk factor. Moreover, BWL remained a significant factor in both the univariate and multivariate analyses in the subset excluding 8 patients who discontinued S-1 because of recurrence. The 6-month continuation rate was 66.4 % in the patients with BWL < 15 and 36.4 % in patients with BWL ≥ 15 % (P = .017). CONCLUSIONS: BWL was the most important risk factor for the compliance of adjuvant chemotherapy with S-1 in the patients with stage 2/3 gastric cancer who underwent D2 gastrectomy. To improve drug compliance that leads to survival, it is a key to maintain body weight before starting S-1 adjuvant. Our study emphasizes the requirement for adequate studies of perioperative nutritional intervention in patients who receive gastrectomy for advanced gastric cancer.

Priority of lymph node dissection for Siewert type II/III adenocarcinoma of the esophagogastric junction.

OBJECTIVE: The purpose of this study was to clarify the priority of nodal dissection in Siewert types II and III adenocarcinoma of the esophagogastric junction (AEG). METHODS: The priority of nodal dissection was evaluated based on the therapeutic value index calculated by multiplying of the frequency of metastasis to each station and the 5-year survival rate of patients with metastasis to that station. RESULTS: A total of 176 patients (95 type II and 81 type III) were examined. Among the lymph nodes that had a metastatic incidence exceeding 10 %, the stations showing the first to fourth highest index were the paracardial and lesser curvature nodes (Nos. 1, 2, and 3) and the node at the root of the left gastric artery (No. 7) in the total cohort, as well as in each type. The next station was the lower thoracic paraesophageal lymph node (No. 110), followed by the nodes along the proximal splenic artery (No. 11p) in type II, whereas it was the nodes along the proximal splenic artery (No. 11p) followed by the para-aortic nodes (No. 16a2), the nodes at the celiac artery (No. 9), and the nodes around the splenic hilum (No. 10) in type III. CONCLUSIONS: These results suggest that the highest priority nodal stations to be dissected were the paracardial and lesser curvature nodes (Nos. 1, 2, and 3) and the nodes at the root of the left gastric artery (No. 7), regardless of the Siewert subtype, but the subsequent priority was different depending on the subtype.

Clinical significance of SPARC gene expression in patients with gastric cancer.

PURPOSE: Secreted protein acidic and rich in cysteine (SPARC) is one of the first known matricellular proteins that modulates interactions between cells and extracellular matrix. Recent studies investigated the clinical significance of SPARC gene expression in the development, progression, and metastasis of cancer. The present study examined the relations of the relative expression of the SPARC gene to clinicopathological factors and overall survival in patients with gastric cancer. METHODS: We studied surgical specimens of cancer tissue and adjacent normal mucosa obtained from 227 patients with previously untreated gastric cancer. The relative expression levels of SPARC mRNA in cancer tissue and in adjacent normal mucosa were measured by quantitative real-time, reverse-transcription polymerase chain reaction. RESULTS: The relative expression level of the SPARC gene was higher in cancer tissue than in adjacent normal mucosa. High expression levels of the SPARC gene were related to serosal invasion (P = 0.046). Overall survival at 5 years differed significantly between patients with high SPARC gene expression and those with low expression (P = 0.006). CONCLUSIONS: Overexpression of the SPARC gene may be a useful independent predictor of outcomes in patients with gastric cancer.

Omentum-preserving gastrectomy for advanced gastric cancer: a propensity-matched retrospective cohort study.

BACKGROUND AND OBJECTIVES: We clarified the impact of omentectomy for advanced gastric cancer on patient survival from the surgical results of a high-volume center in Japan. METHODS: Patients who received curative gastrectomy were divided into two groups based on whether they underwent omentectomy. The propensity score-matching method was used to assemble a well-balanced cohort, and relapse-free survival and the pattern of recurrence were compared. RESULTS: For this study, 330 patients who fulfilled the inclusion criteria participated and were divided into two groups: group R, patients who received omentectomy, and group P, patients who received omentum-preserving gastrectomy. After performing score-matching, 196 patients were selected. The 3- and 5-year relapse-free survival rates were 72.9% (95% confidence interval, 64.1-81.7) and 66.2% (56.6-75.8%) in group R, and 76.7% (67.9-81.2) and 67.3% (55.1-79.5) in group P, which were not significantly different (P = 0.750). Regarding sites of relapses, no differences were observed between the groups (P = 0.863). CONCLUSIONS: In this series, omentum-preserving gastrectomy for advanced gastric cancer did not increase the peritoneal relapse rate or affect patient survival compared to conventional gastrectomy. The non-inferiority of the omission of omentectomy should be evaluated by a randomized controlled trial.

A prospective feasibility and safety study of laparoscopy-assisted distal gastrectomy for clinical stage I gastric cancer initiated by surgeons with much experience of open gastrectomy and laparoscopic surgery.

BACKGROUND: The aim of this prospective study was to evaluate the feasibility and safety of laparoscopy-assisted distal gastrectomy (LADG) initiated by surgeons with much experience of open gastrectomy and laparoscopic surgery. METHODS: Three surgeons who each had experience with more than 300 cases of open gastrectomy, more than 100 cases of laparoscopic cholecystectomy, more than 5 cases of laparoscopic colectomy, and more than 5 cases of laparoscopic partial gastrectomy were nominated as LADG operators. All three operators received training for LADG with study materials including videotapes, a box simulator, and an animal laboratory, with lectures and assistance from LADG instructors who each had experience of more than 50 LADG operations. Then the nominated LADG operators performed LADG with the instructors, in which their skills were evaluated and certified. Thereafter, they performed LADG without assistance from the instructors. The target of this study was clinical stage I gastric cancer that was resectable by distal gastrectomy. D1 + alpha, D1 + beta, or D2 dissection was performed laparoscopically. Basically reconstruction was done extracorporeally with a Billroth-I gastroduodenostomy. An extramural review board checked the surgical quality of the operations performed by the three surgeons. The primary endpoint was morbidity and mortality. RESULTS: A total of 193 patients were enrolled in this study between August 2004 and July 2009. The median blood loss was 35 ml and the median operation time was 250 min. Conversion to open surgery was seen in 6 patients; 4 due to bleeding and 2 due to advanced disease. Overall morbidity was 1.6 %, including grade 2 anastomotic leakage in 0.5 % and grade 2 pancreatic fistula in 0.5 %. No mortality was observed. The number of cases required until the LADG operators acted as LADG surgeons without an instructor was 3 for each of the three surgeons. When comparing the data between that in the training period (n = 9) and the operators' data (n = 174), the median operation time was significantly longer in the training period (355 min) than in the latter period (247.5 min) (p = 0.015). Median blood loss was also greater in the training period (150 ml) than the latter period (32.5 ml), but the difference did not reach statistical significance (p = 0.084). During the training period, no patient developed any complications of ≥ grade 2. CONCLUSION: These results suggested that LADG could be initiated and performed feasibly and safely if surgeons with much experience of open gastrectomy and laparoscopic surgery received adequate training for LADG.

Laparoscopic esophagojejunostomy using the EndoStitch and a circular stapler under a direct view created by the ENDOCAMELEON.

Laparoscopic esophagojejunostomy using a circular stapler is associated with technical difficulties in the purse-string sutures used to insert the anvil head and in obtaining an adequate visual field to prevent rolling the mesentery and the wall of the jejunum on the mesenteric side into the anastomosis. To overcome these difficulties, we used the EndoStitch to create the purse-string suture and the ENDOCAMELEON to create the visual field to stretch the jejunum. After resecting the esophagus, purse-string sutures were placed using the EndoStitch. A total of five to six needle deliveries were performed. Next, the anvil head was inserted into the esophagus. The main unit of the EEA was inserted from the end of the resected jejunum. Then, the scope was changed to the ENDOCAMELEON. The main unit was slowly moved toward the anvil head. After making sure that the mesentery and the wall of the jejunum on the mesenteric side were not rolled into the anastomosis under the visual field created by the ENDOCAMELEON, the main unit was then fired. Thereafter, esophagojejunostomy was successfully completed. This technique was applied in 20 patients between April 2010 and May 2012. Laparoscopic esophagojejunostomy after total gastrectomy for gastric cancer was completed in all 20 patients. No case required conversion to open surgery. Neither anastomotic leakage nor stenosis was observed. This method is simple and useful for laparoscopic esophagojejunostomy after total gastrectomy for gastric cancer.

A randomized phase II trial of omentum-preserving gastrectomy for advanced gastric cancer.

This randomized Phase II trial is being conducted to evaluate the impact of omentectomy for advanced gastric cancer on patient survival. The primary endpoint is the 3-year relapse-free survival rate and the secondary endpoints are 5-year overall survival, intraoperative blood loss, length of the operation and postoperative morbidity (especially postoperative ileus). The planned sample size is 250 patients (125 for complete removal of the omentum and 125 for preservation of the omentum) to determine whether omentum-preserving gastrectomy may be a candidate procedure for a Phase III trial in a randomized Phase II setting.