A Novel Method for Thoracoscopic Overlap Esophagogastric Reconstruction With Pleural Closure following Minimally Invasive Ivor-Lewis Esophagectomy for Esophagogastric Junction Cancer.

BACKGROUND: Intrathoracic esophagogastric anastomosis following minimally invasive Ivor-Lewis esophagectomy is a technically demanding surgical technique that can result in serious intrathoracic infections when anastomotic leakage occurs. Herein, we report a novel side-overlap esophagogastric anastomosis with pleural closure for esophagogastric junction cancer. METHODS: The 3 key points of our novel technique were the following: (1) overlap esophagogastric anastomosis and closure of the entry hole were all performed using a linear stapler; (2) the pleura was closed to separate the anastomotic site from the thoracic cavity; and (3) the mediastinal drain was inserted transhiatally from the abdominal cavity. RESULTS: This modified anastomosis procedure was performed on 8 consecutive patients at our institution. The median overall/thoracoscopic operating time and estimated blood loss were 652.5/241.5 min and 89 mL, respectively. No mortality or serious postoperative complications occurred, and the median postoperative hospital stay was 22 days (range, 17 to 37 d). CONCLUSION: This novel thoracoscopic overlap esophagogastric reconstruction procedure with pleural closure is safe and feasible.

Management of Patients Receiving Antiplatelet Therapy During Gastroenterological Surgery: A Multicenter Prospective Cohort Study (GSATT).

OBJECTIVE: This study aimed to evaluate the effect of continuing preoperative aspirin monotherapy on surgical outcomes in patients receiving antiplatelet therapy (APT). SUMMARY BACKGROUND DATA: The effectiveness of continuing preoperative aspirin monotherapy in patients undergoing APT in preventing thromboembolic consequences is mostly unknown. METHODS: This prospective multicenter cohort study on the Safety and Feasibility of Gastroenterological Surgery in Patients Undergoing Antithrombotic Therapy (GSATT study) conducted at 14 clinical centers enrolled and screened patients between October 2019 and December 2021. The participants (n=1,170) were assigned to the continued APT group, discontinued APT group, or non-APT group, and the surgical outcomes of each group were compared. Propensity score matching was performed between the continued and discontinued APT groups to investigate the effect of continuing preoperative aspirin therapy on thromboembolic complications. RESULTS: The rate of thromboembolic complications in the continued APT group was substantially lower than that in the non-APT or discontinued APT groups (0.5% vs. 2.6% vs. 2.9%; P=0.027). Multivariate investigation of the entire cohort revealed that discontinuation of APT (P<0.001) and chronic anticoagulant use (P<0.001) were independent risk factors for postoperative thromboembolism. The post-matching evaluation demonstrated that the rates of thromboembolic complications were significantly different between the continued and discontinued APT groups (0.6% vs. 3.3%; P=0.012). CONCLUSIONS: APT discontinuation following elective gastroenterological surgery increases the risk of thromboembolic consequences, whereas continuing preoperative aspirin greatly reduces this risk. The continuation of preoperative aspirin therapy in APT-received patients is considered one of the best alternatives for preventing thromboembolism during elective gastroenterological surgery.

Dorsal approach for advanced gastric cancer invading the transverse mesocolon.

Minimally invasive gastrectomy is increasingly performed for advanced gastric cancer, but the indication for this procedure for a tumor invading adjacent structures is still limited. In cases with tumors invading the transverse mesocolon, a large tumor together with the involved mesocolon blocks the surgical view, which prevents evaluation of the extent of invasion and makes it difficult to ensure oncologically adequate resection. To solve these technical issues, we established a novel method that uses a dorsal approach. By approaching the transverse mesocolon from the dorsal side, tumor penetration and involvement of the colic vessels or pancreas can be evaluated, and margin-free resection of the tumor becomes easier. In a series of 13 patients with mesocolon invasion, a dorsal approach enabled minimally invasive margin-free resection in 11 cases by resection of the anterior layer of the mesocolon (n = 6); enucleation of the mesocolon (n = 4); or enucleation plus distal pancreato-splenectomy (n = 1). Two patients with broad invasion that obstructed the view underwent combined colectomy by open conversion. A major postoperative complication of pancreatic fistula following distal pancreatectomy occurred in one case. These results suggest that a dorsal approach may be useful for minimally invasive combined resection of gastric cancer invading the transverse mesocolon.

Mesenteric closure after laparoscopic total gastrectomy with Roux-en-Y reconstruction is effective for prevention of internal hernia: a multicenter retrospective study.

BACKGROUND: Internal hernia (IH) is one of the critical complications after gastrectomy with Roux-en-Y reconstruction, which can be prevented by closing mesenteric defects. However, only few studies have investigated the incidence of IH after laparoscopic total gastrectomy (LTG) with Roux-en-Y reconstruction for gastric cancer till date. This study aimed to assess the efficacy of defect closure for the prevention of IH after LTG. METHODS: This multicenter, retrospective cohort study collected data from 714 gastric cancer patients who underwent LTG with Rou-en-Y reconstruction between 2010 and 2016 in 13 hospitals. We evaluated the incidence of postoperative IH by comparing closure and non-closure groups of Petersen's defect, jejunojejunostomy mesenteric defect, and transverse mesenteric defect. RESULTS: The closure group for Petersen's defect included 609 cases, while the non-closure group included 105 cases. The incidence of postoperative IH in the closure group for Petersen's defect was significantly lower than it was in the non-closure group (0.5% vs. 4.8%, p < 0.001). The closure group for jejunojejunostomy mesenteric defect included 641 cases, while the non-closure group included 73 cases. The incidence of postoperative IH in the closure group of jejunojejunostomy mesenteric defect was significantly lower than that in the non-closure group (0.8% vs. 4.1%, p = 0.004). Out of 714 patients, 41 underwent retro-colic reconstruction. No patients in the transverse mesenteric defect group developed IH. CONCLUSION: Mesenteric defect closure after LTG with Roux-en-Y reconstruction may reduce postoperative IH incidence. Endoscopic surgeons should take great care to prevent IH by closing mesenteric defects.

A long-term follow-up study of minimally invasive Ivor Lewis esophagectomy with linear stapled anastomosis.

BACKGROUND: Minimally invasive esophagectomy (MIE) is increasingly performed to expect lower complication rate compared to open esophagectomy. Studies of minimally invasive Ivor Lewis esophagectomy (MIILE) with circular staplers have reported better outcomes compared to MIE with cervical anastomosis, but frequent anastomotic complications have also been reported. MIILE with linear staplers is a promising alternative, but the long-term functional and oncological outcomes are uncertain. METHODS: To evaluate the functional and oncological outcomes of MIILE with linear stapled anastomosis, a retrospective cohort study was performed in 104 patients who underwent MIILE with linear stapled anastomosis for esophageal malignant tumors. The primary endpoints were the overall complication and anastomotic leak rates. The secondary endpoints were late complications, overall and disease-free survival, and nutritional status at 6 and 12 months after MIILE. RESULTS: Anastomotic leak occurred in 4 patients (3.8%). The short-term complication rate of grade IIIb or higher was 6.7%. During a median 57-month follow-up period, anastomotic stricture occurred in one patient, 7 required hiatal hernia repair, and 2 underwent conduit revision surgery. The 5-year overall survival and disease-free survival rates were 69.3% and 59.5%, respectively. Status of reflux esophagitis at the time of most recent evaluation was grade N/A/B/C/D in 52/10/10/13/8 among 93 patients who had follow-up endoscopy. The mean body weight loss at 6 and 12 months after MIILE was 11.3 and 11.8% with maintenance of the serum albumin level. CONCLUSIONS: MIILE with linear stapled anastomosis is a safe procedure with a low anastomotic complication rate and favorable long-term functional and survival outcomes.

Chronological Changes in Skeletal Muscle Mass Two Years after Minimally Invasive Esophagectomy: A Prospective Cohort Study.

BACKGROUND: Preoperative loss of skeletal muscle mass, defined as sarcopenia, has been reported to be associated with higher incidence of complications following esophagectomy in patients with esophageal cancer. Although skeletal muscle loss promotes disability and reduced quality of life (QOL), only a few studies have focused on changes in skeletal muscle mass after surgery. This prospective cohort study aimed to evaluate the chronological changes in skeletal muscle mass after minimally invasive esophagectomy (MIE). METHODS: Patients with esophageal cancer scheduled to undergo MIE at our institution were prospectively registered. Skeletal muscle mass was evaluated before and 2, 6, 12, and 24 months after surgery. The effects of preoperative sarcopenia on surgical outcomes and chronological changes in skeletal muscle mass were evaluated. RESULTS: Among the 71 eligible preoperative patients, 29 (40.8%) were diagnosed with sarcopenia. Patients with sarcopenia had significantly higher incidences of total (79.3% vs 52.4%, p = 0.026) and gastrointestinal (37.9% vs 11.9%, p = 0.019) complications and a significantly longer length of hospital stay (31 vs 23 days, p = 0.005) than those without sarcopenia. The median skeletal muscle mass index (kg/m2) was 7.09 before surgery, which decreased to 6.46 two months after surgery (- 7.2%, P < 0.01). Thereafter, values of 6.90, 6.86, and 7.06 were reported at 6, 12, and 24 months after surgery, respectively. CONCLUSION: Patients with preoperative sarcopenia developed more postoperative complications than those without it. Additionally, patients experienced a decrease in skeletal muscle mass during the early postoperative period following MIE. Further research on perioperative countermeasures to prevent skeletal muscle loss during the early postoperative period and to prevent postoperative complications is necessary for patients undergoing MIE.

Long-Term Outcomes of Laparoscopic Radical Gastrectomy for Highly Advanced Gastric Cancer: Final Report of a Prospective Phase II Trial (KUGC04).

BACKGROUND: This is the final report evaluating the long-term outcomes of a single-arm phase II clinical trial that demonstrated the short-term efficacy of laparoscopic gastrectomy (LG) for highly advanced gastric cancer (AGC) [KUGC04]. PATIENTS AND METHODS: Seventy-three patients with histologically confirmed gastric adenocarcinoma and diagnosed with clinical stage II or higher, who potentially underwent curative resection between August 2009 and November 2014, were prospectively enrolled. Long-term outcomes with 5-year progression-free survival (PFS) and 5-year overall survival (OS) were evaluated according to clinical or pathological stages. Recurrence and progression patterns were also investigated. These outcomes were compared with those of previous reports to assess the applicability of LG for highly advanced gastric cancer (HAGC). RESULTS: The median observation period of all surviving patients was 75.1 months. The 5-year PFS and 5-year OS of all patients was 47.4% and 54.4%, respectively. Clinical stage-specific 5-year PFS and 5-year OS was 75.0, 69.1, 53.9, 39.4, 40.0 and 9.1, and 75.0, 68.8, 61.5, 45.0, 60.0 and 27.3, respectively, in stages IIA, IIB, IIIA, IIIB, IIIC, and IV, respectively. Pathological stage-specific 5-year PFS and 5-year OS, including ypStage with preoperative chemotherapy, was 100, 80.0, 100, 62.5, 80.0, 51.3, 16.7, 22.2 and 12.5, and 100, 80.0, 100, 75.0, 80.0, 64.2, 25.0, 33.3 and 12.5, respectively, in stage X (no residual tumor with preoperative chemotherapy), IA, IB, IIA, IIB, IIIA, IIIB, IIIC, and IV, respectively. Recurrence or progression was observed in 30 patients (41.1%). CONCLUSION: LG for HAGC performed by experienced surgeons is safe and oncologically acceptable.

PTEN is a predictive biomarker of trastuzumab resistance and prognostic factor in HER2-overexpressing gastroesophageal adenocarcinoma.

Poor trastuzumab (Tmab) response of patients with human epidermal growth factor receptor 2-overexpressing gastric or gastroesophageal junction adenocarcinoma (HER2-GEA) is associated with the inhibition of phosphatase and tensin homolog (PTEN) expression. In this multicenter, retrospective observational study, pathological samples of patients with HER2-GEA receiving Tmab-combined chemotherapy were immunohistochemically analyzed for PTEN expression. The primary endpoints were disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). We assessed the effect of conventional chemotherapy and Tmab alone or combined with PI3K pathway inhibitors in vitro in HER2-GEA cells with or without PTEN expression. Twenty-nine and 116 patients were in the PTEN-loss and PTEN-positive groups, respectively. In patients with the target region, DCR was significantly lower in PTEN-loss patients than in PTEN-positive patients (67% and 87%, respectively, p = 0.049). The multivariate analysis demonstrated that PTEN loss was significantly associated with shorter PFS (HR = 1.63, p = 0.035) and OS (HR = 1.83, p = 0.022). PTEN knockdown did not affect the cytostatic effect of 5-FU and cisplatin, whereas Tmab combined with the PI3K/mTOR inhibitor NPV-BEZ235 suppressed PTEN-knockdown cell proliferation. In patients with HER2-GEA, PTEN loss is a predictive biomarker of Tmab resistance and prognostic factor. Molecular-targeted therapy with a PI3K/mTOR inhibitor would be effective for HER2-GEA with PTEN loss.

Comparison of short-term outcomes between robotic and laparoscopic gastrectomy for gastric cancer: a propensity score-matching analysis.

Robotic gastrectomy (RG) is increasingly performed based on expected benefits in short-term outcomes. However, it is still unclear if RG has any advantages over laparoscopic gastrectomy (LG). A retrospective cohort study was performed in patients who underwent minimally invasive gastrectomy between January 2012 and January 2020. A total of 366 patients were enrolled and short-term outcomes were compared between RG and LG. Propensity score matching was conducted to reduce selection bias based on age, sex, body mass index, performance status, physical status, clinical T, clinical N, clinical M, tumor location, neoadjuvant chemotherapy, type of gastrectomy, and extent of lymphadenectomy. A propensity score-matching algorithm was used to select 93 patients for each group. Estimated blood loss was smaller (0 vs. 37 mL, P = 0.001), length of hospital stay was shorter (10 vs. 12 days, P = 0.012), and the time until starting a soft diet was shorter (3 vs. 4 days, P = 0.001) in RG compared to LG. The overall complication rate was also lower in RG (9.7% vs 14.0%), but the difference was not significant. There was no mortality in either group. Total gastrectomy was an independent risk factor for postoperative complications. RG can be safely performed with a similar complication rate to that in LG and may permit faster postoperative recovery and a shorter hospital stay.

Comparative Outcomes of Laparoscopic Gastrectomy and Open Gastrectomy for Scirrhous Gastric Cancer: A Multicenter Retrospective Cohort Study.

Objective: A multicenter retrospective cohort study was performed to compare the outcomes of laparoscopic gastrectomy (LG) versus open gastrectomy (OG) for scirrhous gastric cancer (GC) as a unique subtype also known as type 4 gastric cancer or linitis plastica. Background: Although data on the efficacy and safety of LG as an alternative to OG are emerging, the applicability of LG to scirrhous GC remains unclear. Methods: Patients with clinical type 4 GC undergoing gastrectomy at 13 hospitals from 2005 to 2015 were retrospectively reviewed. As the primary endpoint, we compared overall survival (OS) between the LG and OG groups. To adjust for confounding factors, we used multivariate Cox regression analysis for the main analyses and propensity-score matching for sensitivity analysis. Short-term outcomes and recurrence-free survival were also compared. Results: A total of 288 patients (LG, 62; OG, 226) were included in the main analysis. Postoperative complications occurred in 25.8% and 30.1%, respectively (P = 0.44). No significant difference in recurrence-free survival was observed (P = 0.72). The 5-year OS rates were 32.4% and 31.6% in the LG and OG groups, respectively (P = 0.60). The hazard ratio (LG/OG) for OS was 0.98 (95% confidence interval [CI], 0.65-1.43) in the multivariate regression analysis. In the sensitivity analyses after propensity-score matching, the hazard ratio for OS was 0.92 (95% CI, 0.58-1.45). Conclusions: Considering the hazard ratios and 95% CIs for OS, LG for scirrhous GC was not associated with worse survival than that for OG.

Educational application of intraoperative records from an energy device in laparoscopic gastrectomy: a preliminary report.

PURPOSE: Video review is a reliable method for surgical education in laparoscopic gastrectomy (LG), but more objective methods are still needed. The purpose of this study was to determine whether the energy device records reflected surgical competency, and thereby may improve surgical education. METHODS: A total of 16 patients who underwent LG for gastric cancer using the Thunderbeat® device were preliminarily retrospectively analyzed. This device has the function of 'intelligent tissue monitoring' (ITM), a safety assist system stopping energy output, and can record ITM detections and firing time during surgery. The number of ITM detections and firings, and the total firing time during gastrocolic ligament dissection and infrapyloric dissection were compared between trainees (n = 9 by 5 surgeons) and experts (n = 7 by 5 surgeons). The non-edited videos (n = 16) were scored, and the correlations between the scores and the records were then analyzed. RESULTS: Significantly more ITM detections, firings, and a longer total firing time were observed in trainees than in experts. The number of ITM detections and firing had negative correlations with the scores of the operation speed, the use of the non-dominant hand, and the use of an energy device. CONCLUSIONS: Our preliminary study suggested that the above described energy device records reflected surgical competency, and thereby may improve surgical education.

A patient with superior mesenteric artery lymph node metastasis after laparoscopic gastrectomy for gastric cancer with Adachi type VI vascular anomaly: A case report.

INTRODUCTION: Due to recent advances in surgical procedures and instruments, laparoscopic gastrectomy for gastric cancer has been widely performed, and previous studies reported laparoscopic surgery for gastric cancer with Adachi type VI vascular anomaly. In Adachi type VI patients, the common hepatic artery (CHA) originates from the superior mesenteric artery (SMA); therefore, the route of lymph flow differs from the normal route, and the supra- and infrapyloric lymph nodes (LN) may reach SMA LN. However, metastasis has not yet been reported. A case of SMA LN metastasis 3 years after laparoscopic distal gastrectomy for gastric cancer with Adachi type VI CHA anomaly, which was diagnosed using preoperative computed tomography (CT), was described herein. PRESENTATION OF CASE: The patient was a 77-year-old male. Laparoscopic distal gastrectomy and D2 + 14v LN dissection for gastric cancer with Adachi type VI vascular anomaly were performed. Three years after surgery, periodic CT revealed swelling of regional and mediastinal SMA LN, leading to a diagnosis of recurrent gastric cancer. A histopathological examination of the resected specimen showed metastases to the greater curvature right group and infrapyloric LN. DISCUSSION: Metastasis to LN No. 6 may have reached SMA LN via the gastroduodenal artery and CHA, but not the celiac artery. CONCLUSION: If preoperative diagnostic imaging suggests metastasis to the greater curvature right group and pyloric regions in gastric cancer patients with Adachi type VI vascular anomaly, LN dissection along CHA originating from SMA and the hepatomesenteric trunk needs to be considered.

Mesenteric excision of upper esophagus: a concept for rational anatomical lymphadenectomy of the recurrent laryngeal nodes in thoracoscopic esophagectomy.

BACKGROUND: The recurrent laryngeal nerve (RLN) lymph nodes are among the most frequently involved lymph nodes in esophageal cancer. Surgical removal of these lymph nodes is considered beneficial for postoperative prognosis, especially in patients with squamous cell carcinoma. Unfortunately, the precise surgical anatomy of the upper mediastinum is not well understood and no distinct high-resolution images are currently available. METHODS: In this article, we provide a simple intuitive concept of upper mediastinal surgical anatomy that could facilitate rational anatomical lymphadenectomy of the RLN lymph nodes. The essential concept of this mesenteric excision is to mobilize mesoesophagus including RLN in an en bloc fashion and to save RLN laterally by incising visceral sheath. This is applicable identically to both right and left upper mediastinum. RESULTS: Between January 2009 and December 2017, thoracoscopic esophagectomy with upper mediastinal lymphadenectomy for primary esophageal cancer was performed in 189 patients. Median thoracoscopic procedure time was 297 (range 205-568) min and median intraoperative blood loss was 70 ml (range unmeasurable up to 2545 ml). Median number of harvested upper mediastinal lymph nodes was 12. Postoperative complication of Clavien-Dindo classification grade III or higher events was observed in 14% of patients. RLN palsy of grade II or higher occurred in 20 patients (11%). CONCLUSION: The mesoesophagus in the upper mediastinum is an anatomical unit surrounded by fibrous connective tissue containing the esophagus, trachea, tracheoesophageal vessels, lymphatic tissue, and RLNs. Thus, mesenteric excision of esophagus is defined to resect this area by sparing trachea and RLNs for rational anatomical lymphadenectomy. We believe that this concept makes upper mediastinal lymphadenectomy safer and more appropriate.

Linear or circular stapler? A propensity score-matched, multicenter analysis of intracorporeal esophagojejunostomy following totally laparoscopic total gastrectomy.

BACKGROUND: Presently, there is no consensus as to what procedure of intracorporeal esophagojejunostomy (EJS) in totally laparoscopic total gastrectomy (TLTG) is best to reduce postoperative complications. The aim of this study was to demonstrate the superiority of linear stapled reconstruction in terms of anastomotic-related complications for EJS in TLTG. METHODS: We collected data on 829 consecutive gastric cancer patients who underwent TLTG reconstructed by the Roux-en-Y method with radical lymphadenectomy between January 2010 and December 2016 in 13 hospitals. The patients were divided into two groups according to reconstruction method and matched by propensity score. Postoperative EJS-related complications were compared between the linear stapler (LS) and the circular stapler (CS) groups. RESULTS: After matching, data from 196 patients in each group were analyzed. The overall incidence of EJS-related complications was significantly lower in the LS group than in the CS group (4.1% vs. 11.7%, p = 0.008). The incidence of EJS anastomotic stenosis during the first year after surgery was significantly lower in the LS group than in the CS group (1.5% vs. 7.1%, p = 0.011). The incidence of EJS bleeding did not differ significantly between the groups, although no bleeding was observed in the LS group (0% vs. 2.0%, p = 0.123). The incidence of EJS leakage did not differ significantly between the groups (2.6% vs. 3.6%, p = 0.771). CONCLUSION: The use of linear stapled reconstruction is safer than the use of circular stapled reconstruction for intracorporeal EJS in TLTG because of its lower risks of stenosis.

A Randomized Phase II Study of S-1 Adjuvant Chemotherapy With or Without Hochu-ekki-to, a Japanese Herbal Medicine, for Stage II/III Gastric Cancer: The KUGC07 (SHOT) Trial.

Objectives: A multicenter randomized phase II study was conducted to evaluate the effects of Hochu-ekki-to (TJ-41) for reducing adverse reactions and increasing compliance with S-1 adjuvant therapy for advanced gastric cancer. Methods: The eligibility criteria were pathological stage II/III after R0 resection. Patients received adjuvant therapy with S-1 alone (group S) or S-1 with TJ-41 (group ST) for 1 year. The primary endpoint was the completion rate of S-1. Secondary endpoints were adverse events, relative dose intensity, relapse-free survival (RFS), and overall survival (OS). Results: We randomly assigned 56 patients to group ST and 57 patients to group S. The completion rates of S-1 were 54.5 and 50.9%, the median relative dose intensities were 89.2 and 71.9%, and adverse events of grade 3 or 4 occurred in 45.5 and 54.5% in groups ST and S, respectively. There was no significant difference in 3-year OS or RFS between the two groups. Conclusions: TJ-41 does not increase relative dose and completion rate of S-1 significantly. J-41 may reduce toxic effects, but our findings do not support routine use of TJ-41 after gastrectomy.

Feasibility of robotic radical gastrectomy using a monopolar device for gastric cancer.

PURPOSES: Laparoscopic gastrectomy using ultrasonic devices occasionally causes postoperative pancreatic fistula. Robotic gastrectomy using monopolar scissors may reduce intraoperative injury to the pancreas. We evaluated the safety and feasibility of robotic gastrectomy. METHODS: A multicenter prospective study was conducted to evaluate the surgical outcomes of robotic gastrectomy. The primary endpoints were the incidence of intraoperative and postoperative complications and operative mortality. RESULTS: A total of 115 patients were enrolled. The clinical T stages were T1 in 68 patients and T2 or higher in 47 patients. The types of surgery included distal gastrectomy (n = 72), total gastrectomy (n = 39), and proximal gastrectomy (n = 4). Two patients developed intraoperative complications (1.7%), but no cases required conversion to open surgery. The amylase concentration in drainage fluid was higher in cases with pancreatic compression, especially in those with compression for longer than 20 min. Postoperative complications of Clavien-Dindo grade ≥ II occurred in 11 patients (9.6%). There was no mortality. A multivariate analysis indicated that a high body mass index and pancreatic compression by an assistant for longer than 20 min were independent risk factors for postoperative complications (P = 0.029 and P = 0.010). CONCLUSIONS: Robotic gastrectomy using monopolar scissors is safe and feasible. Robotic dissection without compression of the pancreas may reduce postoperative complications.

A Phase 2 Study of Induction Chemotherapy Using Docetaxel, Cisplatin, and S-1 for Gastric Cancer with Peritoneal Metastasis (KUGC06).

BACKGROUND: The authors previously showed the significant efficacy of S-1 plus cisplatin for gastric cancer with limited peritoneal metastasis. They conducted a phase 2 study to evaluate the safety and efficacy of induction chemotherapy using a docetaxel, cisplatin, and S-1 (DCS) triplet regimen to treat gastric cancer with peritoneal metastasis. METHODS: The key eligibility criteria were gastric cancer with peritoneal metastasis or positive peritoneal cytology but no other distant metastases and capability of oral administration. The patients received three 28-day cycles of DCS (60 mg/m2 of cisplatin, 40 mg/m2 of docetaxel on day 1, and 80 mg/m2 of S-1 from day 1 to day 14), then underwent D2 gastrectomy if R0 was possible. The primary end point was the R0 resection rate. The sample size was determined to have 80% power for detecting a 20% improvement in the R0 resection rate over a 45% baseline for a one-tailed alpha of 0.1. RESULTS: Among 30 enrolled patients, 24 completed three cycles of DCS. The most frequent grade 3 or 4 toxicity was neutropenia (60%). A complete response of peritoneal metastasis was observed in 16 patients, and 14 patients achieved R0 resection (47%; 95% confidence interval 28-66%). When the extent of peritoneal metastasis was classified as P0CY1, P1, P2, and P3 according to the Japanese classification, the R0 resection rates were respectively 63%, 60%, 46% and 0%. CONCLUSIONS: Induction chemotherapy with DCS is safe and can achieve R0 resection for some patients with limited peritoneal metastasis or positive peritoneal cytology. The efficacy, however, appears similar to that of S-1 plus cisplatin.

Clinical advantages of robotic gastrectomy for clinical stage I/II gastric cancer: a multi-institutional prospective single-arm study.

BACKGROUND: Robotic gastrectomy (RG) for gastric cancer (GC) has been increasingly performed for a decade; however, evidence for its use as a standard treatment has not yet been established. The present study aimed to determine the safety, feasibility, and effectiveness of RG for GC. METHODS: This multi-institutional, single-arm prospective study, which included 330 patients from 15 institutions, was designed to compare morbidity rate of RG with that of a historical control (conventional laparoscopic gastrectomy, LG). This trial was approved for Advanced Medical Technology ("Senshiniryo") B. The included patients were operable patients with cStage I/II GC. The primary endpoint was morbidity (Clavien-Dindo Grade ≥ IIIa). The specific hypothesis was that RG could reduce the morbidity rate to less than half of that with LG (6.4%). A sample size of 330 was considered sufficient (one-sided alpha 0.05, power 80%). RESULTS: Among the 330 study patients, the protocol treatment was suspended in 4 patients. Thus, 326 patients fully enrolled and completed the study. The median patient age and BMI were 66 years and 22.4 kg/m2, respectively. Distal gastrectomy was performed in 253 (77.6%) patients. The median operative time and estimated blood loss were 313 min and 20 mL, respectively. No 30-day mortality was seen, and morbidity showed a significant reduction to 2.45% with RG (p = 0.0018). CONCLUSIONS: RG for cStage I/II GC is safe and feasible. It may be effective in reducing morbidity with LG.