Open Distal Gastrectomy Research Articles

Learning curve and short-term outcomes of modularized LADG for advanced gastric cancer: A retrospective study.

Laparoscopy-assisted distal gastrectomy (LADG) is a complicated procedure. To reduce the difficulty of the operation and standardize the surgical procedure, we explored a new operation mode, which we termed modularized LADG (MLADG). To further extend the new operation mode, we conducted this study to evaluate the short-term outcomes of MLADG for advanced gastric cancer, and determine the learning curve.Data from 100 consecutive patients who received LADG between October 2016 and October 2017 were retrospectively analyzed. Short-term outcomes, such as operation time and intraoperative blood loss, were evaluated, and the learning curve was calculated.For MLADG, the mean operation time was 168.2 ± 13.0 minutes, the mean intraoperative blood loss was 93.6 ± 29.1 ml, the mean number of harvested lymph nodes was 28.6 ± 4.2, and conversion to open surgery occurred in only 1 case. In addition, MLADG had an acceptable postoperative complication incidence and fast postoperative recovery. After the first 20 cases, the operation skill reached a mature and stable level.Our results indicate that MLADG is an oncologically feasible and technically safe surgical procedure. For the trainees with rich experience in open distal gastrectomy, the learning curve is considered to be completed after 20 MLADG cases.

Safety and Feasibility of Robotic Distal Gastrectomy for Stage IA Gastric Cancer: A Phase II Trial

BackgroundConventional laparoscopic and open distal gastrectomy procedures have inherent limitations such as restricted movement of straight forceps and tremor of the tip of the devices that can potentially be overcome using robotic distal gastrectomy (RDG). This single-institutional phase II trial aimed to evaluate the safety and feasibility of RDG with lymph node dissection for clinical stage IA gastric cancer. MethodsThe study included patients with clinical stage IA gastric cancer in the lower two-thirds of the stomach considered to be curatively resected via distal gastrectomy. The primary end point was the proportion of patients who developed intra-abdominal complications, requiring medical or interventional treatment. The planned sample size was 25, calculated based on an expected complication rate of 3% and a threshold complication rate of 15%, with a one-sided alpha of 10%, power of 70%. ResultsOverall postoperative complications rate was 16%. The proportion of patients who developed intra-abdominal complications, requiring treatment was 0% (90% confidence interval, 0–9.8%). No patient developed in-hospital adverse events of grade 3 or higher. The short-term clinical outcomes were as follows: the median duration of postoperative hospital stay was 7 d, and 10 patients (40.0%) had a body temperature of 38°C or higher during their hospital stay. ConclusionsThis trial confirmed the safety of RDG with limitation by the restriction of dedicated surgeons. A phase III trial to confirm the superiority of RDG to conventional laparoscopic distal gastrectomy is warranted.

Effect of Laparoscopic Distal Gastrectomy vs Open Distal Gastrectomy on Long-term Survival Among Patients With Stage I Gastric Cancer

Laparoscopic distal gastrectomy is gaining popularity over open distal gastrectomy for gastric cancer because of better early postoperative outcomes. However, to our knowledge, no studies have proved whether laparoscopic distal gastrectomy is oncologically equivalent to open distal gastrectomy. To examine whether the long-term survival among patients with stage I gastric cancer undergoing laparoscopic distal gastrectomy is noninferior to that among patients undergoing open distal gastrectomy. The Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) group, which includes 15 surgeons from 13 institutes, conducted a phase 3, multicenter, open-label, noninferiority, prospective randomized clinical trial (KLASS-01) of patients with histologically proven, preoperative clinical stage I gastric adenocarcinoma from January 5, 2006, to August 23, 2010. Survival and recurrence status of the patients was determined in December 2016. Patients were randomly assigned (1:1) to laparoscopic distal gastrectomy (n = 705) or open distal gastrectomy (n = 711). Of these patients, 85 received a surgical approach opposite the one to which they were randomized (63 randomized to the open surgery group and 22 to the laparoscopic group). Difference in 5-year overall survival between the laparoscopic and open distal gastrectomy groups. The noninferiority margin was prespecified as -5% (corresponding hazard ratio of 1.54), with an assumed survival of 90% after 5 years in the open surgery group. Among the 1416 patients (mean [SD] age, 57.3 [11.1] years; 940 [66.4%] male) included in the study, the 5-year overall survival rates were 94.2% in the laparoscopic group and 93.3% in the open surgery group (log-rank P = .64). Intention-to-treat analysis confirmed the noninferiority of the laparoscopic approach compared with the open approach (difference, 0.9 percentage points; 1-sided 97.5% CI, -1.6 to infinity). The 5-year cancer-specific survival rates were similar between the 2 groups (97.1% in the laparoscopic group and 97.2% in the open surgery group, log-rank P = .91; difference, -0.03 percentage points; 1-sided 97.5% CI, -1.8 to infinity). Per-protocol analysis results were consistent with the intention-to-treat results for overall and cancer-specific survival rates. The KLASS-01 trial revealed similar overall and cancer-specific survival rates between patients receiving laparoscopic and open distal gastrectomy. Laparoscopic distal gastrectomy is an oncologically safe alternative to open surgery for stage I gastric cancer. ClinicalTrials.gov identifier: NCT00452751.

Oncologic outcomes after laparoscopic and open distal gastrectomy for advanced gastric cancer: A propensity score matching analysis.

135 Background: The aim of this study is to investigate the oncologic outcomes as well as short-term outcomes of laparoscopic distal gastrectomy compared with open distal gastrectomy for advanced gastric cancer using propensity-score matching analysis. Methods: A total of 384 patients underwent distal gastrectomy for advanced gastric cancer from July 2006 to November 2016. Data on short- and long-term outcomes were collected prospectively and reviewed. Propensity-score matching was applied at a ratio of 1:1 comparing the laparoscopic distal gastrectomy (LDG) group and open distal gastrectomy (ODG) groups. Results: The LDG group showed longer operative time than the ODG group. However, resumption of diet and length of hospital stay were shorter in the LDG group than in the ODG group (4.7 vs. 5.6 days, p= 0.049 and 9.6 vs. 11.5 days, p= 0.035, respectively).The extent of lymph node dissection in the LDG group was more limited than in the ODG group ( p= 0.002), although there was no difference in the number of retrieved lymph nodes between the two groups. The 3-year overall survival rates were 98% and 86.9% ( p= 0.018), whereas the 3-year recurrence-free survival were 86.3% and 75.3%, p= 0.259) in the LDG and the ODG groups. Conclusions: Laparoscopic distal gastrectomy is safe and feasible for advanced gastric cancer in terms of earlier recovery after surgery and long-term oncologic outcomes.

Oncologic Outcomes after Laparoscopic and Open Distal Gastrectomy for Advanced Gastric Cancer: Propensity Score Matching Analysis.

PurposeThis study aimed to compare the oncologic and short-term outcomes of laparoscopic distal gastrectomy (LDG) and open distal gastrectomy (ODG) for advanced gastric cancer (AGC).Materials and MethodsFrom July 2006 to November 2016, 384 patients underwent distal gastrectomy for AGC. Data on short- and long-term outcomes were prospectively collected and reviewed. Propensity score matching was applied at a ratio of 1:1 to compare the LDG and ODG groups.ResultsThe operative times were longer for the LDG group than for the ODG group. However, the time to resumption of diet and the length of hospital stay were shorter in the LDG group than in the ODG group (4.7 vs. 5.6 days, P=0.049 and 9.6 vs. 11.5 days, P=0.035, respectively). The extent of lymph node dissection in the LDG group was more limited than in the ODG group (P=0.002), although there was no difference in the number of retrieved lymph nodes between the 2 groups. The 3-year overall survival rates were 98% and 86.9% (P=0.018), and the 3-year recurrence-free survival rates were 86.3% and 75.3% (P=0.259), respectively, in the LDG and ODG groups.ConclusionsLDG is safe and feasible for AGC, with earlier recovery after surgery and long-term oncologic outcomes comparable to those of ODG.

Short-term surgical outcomes of laparoscopy-assisted versus open D2 distal gastrectomy for locally advanced gastric cancer in North China: a multicenter randomized controlled trial

BackgroundAlthough laparoscopic surgery has been recommended as an optional therapy for patients with early gastric cancer, whether patients with locally advanced gastric cancer (AGC) could benefit from laparoscopy-assisted distal gastrectomy (LADG) with D2 lymphadenectomy remains elusive due to a lack of comprehensive clinical data. To evaluate the efficacy of LADG, we conducted a multi-institutional randomized controlled trial to compare laparoscopy-assisted versus open distal gastrectomy (ODG) for AGC in North China.MethodsIn this RCT, after patients were enrolled according to the eligibility criteria, they were preoperatively assigned to LADG or ODG arm randomly with a 1:1 allocation ratio. The primary endpoint was the morbidity and mortality within 30 postoperative days to evaluate the surgical safety of LADG. The secondary endpoint was 3-year disease-free survival. This trial was registered at ClinicalTrial.gov as NCT02464215.ResultsBetween March 2014 and August 2017, a total of 446 patients with cT2-4aN0-3M0 (AJCC 7th staging system) were enrolled. Of these, 222 patients underwent LADG and 220 patients underwent ODG were included in the modified intention-to-treat analysis. The compliance rate of D2 lymph node dissection was identical between the LADG and ODG arms (99.5%, P = 1.000). No significant difference was observed regarding the overall postoperative complication rate in two groups (LADG 13.1%, ODG 17.7%, P = 0.174). No operation-related death occurred in both arms.ConclusionsThis trial confirmed that LADG performed by credentialed surgeons was safe and feasible for patients with AGC compared with conventional ODG.

Comparison of Laparoscopic Distal Gastrectomy With Open Distal Gastrectomy for Patients With Advanced Gastric Cancer: A Single-Center Analysis From a Community Hospital

Objective: This study is aimed to investigate the safety and efficacy of laparoscopic distal gastrectomy (LDG) at the community hospital. Summary of Background Data: Although various clinical trials have shown that laparoscopic distal gastrectomy was feasible in patients with early gastric cancer, its safety and efficacy for patients with advanced gastric cancer need to be elucidated. Methods: Patients with pathological Stage IB-III gastric cancer who underwent open distal gastrectomy (ODG) or LDG with D1+ or more extended lymph node (LN) dissection between 2007 and 2014 were eligible for this retrospective study. Patient characteristics, clinicopathologic factors, and post-treatment recurrence were recorded. To evaluate the safety of the surgery, surgical outcomes and postoperative complication were investigated. Results: 638 patients underwent gastrectomy for gastric cancer, with 67 patients included in ODG group and 61 included in LDG group. Patients in the ODG group showed significantly more progressive disease than those in the LDG group. Postoperative infectious complications, [≥Clavien-Dindo (C-D) classification grade III] occurred 6% in all patients, and there was no significant difference between groups. Hospital stay (median, range) was (9, 6–45) in ODG and (7, 5–58) in LDG, with significantly shorter stays in the LDG group (<0.001). Conclusions: LDG could be safely performed for advanced gastric cancer in a community hospital. However, long-term outcomes, including types of postoperative recurrence, need further evaluation.

Surgical treatment strategy for advanced gastric cancer

There are large amount of gastric cancer patients in China, and because of current medical care situation in China, most of the patients have been diagnosed with advanced stage. Surgery is still an important method for patients with advanced gastric cancer, to cure or improve their survival. For lymph node dissection of resectable advanced gastric cancer, D2 radical resection as a standard progressive lymph node dissection of gastric cancer is gradually accepted by East Asian countries and more and more western countries. As recommended by the 8th AJCC-TNM staging, ≥16 lymph nodes for pathological examination are needed to provide better survival, and ≥30 lymph nodes allows better evaluation for prognosis. After years of research, surgical experts have found that D1+ is not suitable for advanced gastric cancer. The III phase clinical trials for advanced gastric cancer, JLSSG 0901 in Japan and KLASS-02 in Korea, have been carried out to confirm that the long-term survival of laparoscopic surgery is no worse than traditional open surgery. CLASS-01 III phase study performed by Chinese laparoscopic gastroenterological study group compared the efficacy between laparoscopic and open distal gastrectomy with D2 lymph node dissection for advanced gastric cancer. The short-term report showed that the laparoscopic surgery has favorable safety, effectiveness, and satisfactory oncologic effect. With the development of conversion therapy, IV stage gastric cancer was divided into 4 types: potential resectable metastasis, borderline resectable metastasis, incurable metastasis and unresectable metastasis. And it is proposed that patients of the 2nd, and some of the 3rd and 4th types are suitable for conversion therapy. Surgery should be performed when tumor has maximal response to chemotherapy. In addition, palliative resection or short circuited surgery may be selected for patients who are refractory to conversion therapy or have some complications such as pyloric stenosis or obstruction, perforation of the tumor, or massive hemorrhage that cannot be alleviated.

Introduction of minimally invasive surgery for distal and total gastrectomy: a population-based study

BackgroundMinimally invasive gastrectomy has been introduced in Western populations during the last decade. As minimally invasive distal gastrectomy (MIDG) versus total gastrectomy (MITG) are procedures with a different complexity, outcomes may differ. The aim of this population-based cohort study was to evaluate the safety of MIDG and MITG. Materials and methodsAll patients who underwent potentially curative gastrectomy for gastric adenocarcinoma were included from the Dutch Upper GI Cancer Audit (2011–2016). Propensity score matching was applied to create comparable groups of patients receiving open distal gastrectomy (ODG) versus MIDG and open total gastrectomy (OTG) versus MITG, using patient and tumor characteristics. Postoperative outcomes and short-term oncological outcomes were appraised. ResultsOf the 1970 eligible patients, 1138 underwent distal gastrectomy and 832 underwent total gastrectomy. For distal gastrectomy, 390 ODG were matched to 288 MIDG patients. Although overall postoperative morbidity and mortality were similar, patients who underwent MIDG encountered less intra-abdominal abscesses (4% vs. 1%, p = 0.039) and wound complications (6% vs. 2%, p = 0.021). The median hospital stay was shorter after MIDGs (9 vs. 7 days, p < 0.001). For total gastrectomy, 323 OTG patients were matched to 258 MITG patients. Overall postoperative morbidity, mortality and hospital stay were similar, whereas the anastomotic leakage rate was higher after MITGs (11% vs. 17%, p = 0.030). Short-term oncological outcomes between both groups were equal for distal and total gastrectomy. ConclusionBenefits of MIG during the early introduction were demonstrated for distal gastrectomy but not for total gastrectomy. An increased anastomotic leakage rate was encountered for MITG.

Laparoscopic or open distal gastrectomy after neoadjuvant chemotherapy for advanced gastric cancer: study protocol for a randomised phase II trial

IntroductionCurrent guidelines recommend open gastrectomy with D2 lymph node dissection and adjuvant chemotherapy as the standard treatment for advanced gastric cancer. However, the prognosis is not satisfactory. Perioperative chemotherapy has...

Long-term outcomes of laparoscopy-assisted distal gastrectomy versus open distal gastrectomy for gastric cancer: a 10-year single-institution experience.

Laparoscopy-assisted distal gastrectomy (LADG) for gastric cancer has been widely applied; however, its oncologic efficacy has yet been well established. The study aimed to compare the long-term oncologic outcomes of LADG versus open distal gastrectomy (ODG) on gastric cancer. The clinicopathologic data of gastric cancer patients who underwent distal gastrectomy with curative intent from October 2004 through September 2014 were included and analyzed in a retrospective cohort. The last follow-up was September 2016. 769 eligible patients (LADG 414 vs. ODG 355) were included in the study. No significant difference was observed between the groups in 5-year DFS (LADG 61.2% vs. ODG 59.1%; p = 0.384) and OS rates (LADG 65.8% vs. ODG 66.3%; p = 0.750). During surgery, though LADG group had longer operating time, the blood loss was less than ODG group. LADG group had faster postoperative recovery course including shorter time to oral intake, ambulation, and discharge time. Postoperative complication rate within 30days showed no significant difference between the groups (LADG 15.7% vs. ODG 13.0%; p = 0.281). Age over 65years old, blood loss > 200ml, postoperative complication, and advanced T and N stage were identified as independent risk factors for DFS and OS. LADG could yield similar oncologic outcomes compared with ODG in treating distal gastric cancer. However, the findings need to be further confirmed through ongoing prospective randomized controlled trials.

Feasibility of Laparoscopic Distal Gastrectomy for Stage I Gastric Cancer in Patients Outside of Clinical Trials

BackgroundRandomized controlled trials, including the Japan Clinical Oncology Group (JCOG) 0912 trial, have shown the safety of laparoscopy-assisted distal gastrectomy (LADG) for select healthy patients. It is unclear whether LADG is feasible in patients who do not meet trial eligibility criteria. MethodsThe present study retrospectively reviewed 547 patients with clinical stage I gastric cancer who underwent distal or pylorus-preserving gastrectomy. Of these, 185 were identified as not fulfilling the eligibility criteria of JCOG 0912; the short-term surgical outcomes between LADG and open distal gastrectomy (ODG) were compared in this group before and after propensity score matching. ResultsPatients who were not eligible for inclusion in the trial comprised 33.8% of the total. After matching, there were 59 patients each in the LADG and ODG groups, with an improved balance of confounding factors between the two groups. LADG was associated with significantly longer operation time, less blood loss, and shorter postoperative hospital stay than ODG. The rate of overall postoperative complications of Clavien–Dindo Grade II or higher did not differ significantly between the LADG and ODG groups (23.7 vs. 18.6%, respectively; p=0.653). The incidence of pneumonia (6.8 vs. 5.1%), intra-abdominal infectious complications (5.1 vs. 3.4%), and stasis syndrome (5.1 vs. 3.4%) was also comparable between the two groups. ConclusionLADG was as safe as ODG in patients who did not meet the eligibility criteria of JCOG 0912. LADG could be a standard treatment option for patients with stage I gastric cancer, regardless of their general condition.

Morbidity and mortality of elderly patients with advanced gastric cancer after laparoscopy-assisted or open distal gastrectomy: a randomized-controlled trial.

Laparoscopy-assisted distal gastrectomy (LDG) combined with D2 lymphadenectomy may be safely performed in patients with advanced gastric cancer (AGC) by experienced surgeons at specialized high-volume institutions as shown in the Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS)-01. However, studies focusing on the use of LDG in patients with gastric cancer older than 65 years are rare. This study was designed to investigate the morbidity and mortality of elderly patients with gastric cancer who underwent laparoscopic-assisted or open distal gastrectomy (ODG). In this prospective, randomized, open, parallel controlled trial, patients older than 65 years with tumor located at the middle or lower part of the stomach will be enrolled in this study. Patients will be randomly divided into a laparoscopic group and an open surgery group. The early post-operative complications, intra-operative complications and post-operative recovery will be compared between the two groups. This trial will provide valuable clinical evidence for the objective assessment of the feasibility, short-term safety, and potential benefits of LDG compared with ODG for gastric cancer in the elderly patients. This trial has been registered on ClinicalTrials.gov. (Identifier: NCT02246153.) in September 22, 2014.

Midterm body composition changes after open distal gastrectomy for early gastric cancer.

PurposeThis study evaluated midterm changes in body composition after open distal gastrectomy for early gastric cancer.MethodsData from 138 gastric cancer patients who underwent open distal gastrectomy at Kyungpook National University Chilgok Hospital between January 2011 and December 2012 were collected and reviewed. Patients with pathological stage I gastric cancer and with no comorbidities at diagnosis were enrolled. Body composition data from segmental multifrequency bioelectrical impedance analysis were obtained preoperatively and at 1, 2, and 3 years after surgery.ResultsThe mean body weight losses at 1 and 3 years after surgery were 6.1 kg and 5.8 kg, respectively (P < 0.001). The protein mass, skeletal muscle mass, and fat-free mass decreased continuously until 3 years after surgery (0.5 kg, 1.6 kg, and 2.4 kg, respectively; P < 0.001). The average body fat mass and visceral fat area loss at 1 year after surgery were 4.7 kg and 20.5 cm2, respectively (P < 0.001). After 1 postoperative year, the body fat mass and visceral fat areas increased continuously, up to 12.2 kg and 74.2 cm2 at 3 years after surgery, respectively (+1.4 kg and +1.2 cm2, respectively).ConclusionMore intense nutritional and exercise programs may be important after gastric cancer surgery, especially during the first postoperative year.

Surgical outcomes of laparoscopic distal gastrectomy compared to open distal gastrectomy: A retrospective cohort study based on a nationwide registry database in Japan.

To clarify the safety profile of laparoscopic distal gastrectomy (LDG) for gastric cancer patients, the short‐term outcome of LDG was compared to that of open distal gastrectomy (ODG) by propensity score matching using data from the Japanese National Clinical Database (NCD). We conducted a retrospective cohort study of patients undergoing distal gastrectomy between January 2012 and December 2013. Using the data for 70 346 patients registered in the NCD, incidences of mortality and morbidities were compared between LDG patients and ODG patients in the propensity score matched stage I patients (ODG: n = 14 386, LDG: n = 14 386) and stage II‐IV patients (ODG: n = 3738, LDG: n = 3738), respectively. There was no significant difference in mortality rates between LDG and ODG at all stages. Operating time was significantly longer in LDG compared to ODG, whereas blood loss and incidences of superficial surgical site infection (SSI), deep SSI, and wound dehiscence were significantly higher in ODG at all stages. Interestingly, pancreatic fistula was found significantly more often in LDG (1%) compared to ODG (0.8%) (P = .01) in stage I patients; however, it was not different in stage II‐IV patients. The length of postoperative stay was significantly longer in patients undergoing ODG compared to LDG at all stages. LDG in general practice might be a feasible therapeutic option in patients with both advanced gastric cancer and those with early gastric cancer in Japan.

Higher incidence of pancreatic fistula in laparoscopic gastrectomy. Real-world evidence from a nationwide prospective cohort study.

Laparoscopic distal gastrectomy (LDG) is becoming the standard procedure for gastric cancer. However, supporting evidence thus far has been derived primarily from randomized control trials conducted by centers of excellence. In the present study we used the National Clinical Database (NCD) in Japan to prospectively accumulate data from diverse types of hospitals and examine whether LDG is a safe and valid standard procedure. From the NCD, 169 institutions were selected to form a cohort that was considered to be representative of Japan. From August 2014 to July 2015, 5288 patients who underwent LDG were registered prospectively, and clinical data were acquired through the NCD. To compare surgical outcomes between open distal gastrectomy (ODG) and LDG, we adjusted for confounding factors using propensity score matching, ultimately retrieving data from 1067 patients in each group. There were no significant differences in the number of in-hospital deaths in the ODG and LDG groups (3/1067 vs. 6/1067; P=0.51) or in the number of reoperations (20/1067 vs. 29/1067; P=0.19). However, the length of hospital stay was significantly shorter in the LDG. Although wound infection and dehiscence were more common in the ODG group, LDG was more often associated with grade B or higher pancreatic fistulas. The safety and minimal invasiveness of LDG were confirmed in the present Japanese nationwide survey. However, care must be taken to prevent the formation of pancreatic fistulas with LDG, and further improvements in surgical quality are warranted in this regard.

Laparoscopic Distal Gastrectomy is Feasible in Very Elderly Patients as Compared with Open Distal Gastrectomy

ABSTRACTLaparoscopic gastrectomy was shown to be feasible even in elderly patients in many retrospective case-controlled studies. However, the definition of elderly differed among those studies, such as an age of 65, 70, or 75 years or older. This study was conducted to elucidate the advantages of laparoscopic distal gastrectomy (LDG) in very elderly (≥80 years) patients, and comprised 70 patients, 45 of whom underwent LDG and 25 underwent open distal gastrectomy (ODG) between 2004 and September 2016. LDG had significantly less estimated blood loss (p < .01), earlier flatus (p < .01), earlier food intake (p < .01), and shorter hospitalization (p < .01) as compared with ODG. No significant difference between LDG and ODG was found in the incidence of postoperative surgical complications (p = .40), although LDG tended to reduce overall and medical postoperative complications (p = .11 and .09, respectively). LDG might be a feasible, beneficial treatment with good short-term outcomes in very elderly patients with gastric cancer.

Short-term outcomes from a multi-institutional, phase III study of laparoscopic versus open distal gastrectomy with D2 lymph node dissection for locally advanced gastric cancer (JLSSG0901).

4029 Background: The safety of laparoscopic gastrectomy for advanced gastric cancer is controversial. We conducted a multi-institutional, randomized controlled trial to compare short- and long-term outcomes of laparoscopic distal gastrectomy (LAP) with D2 lymph node dissection for advanced gastric cancer in comparison to open distal gastrectomy (OP) in Japan (UMIN000003420). We herein demonstrate short-term outcomes of this trial. Methods: Patients with potentially curable gastric cancer (T2-T4, N0-2 and M0) by distal gastrectomy were eligible for inclusion. Between November 2009 and July 2016, 507 patients were randomly assigned to either the LAP group (n = 252) or the OP group (n = 255). Only credentialed surgeons in both the procedures from 37 Japanese institutions participated in the study. The primary endpoint was 5-year relapse free survival. Secondary endpoints were 5-year overall survival, adverse events and short-term clinical outcomes. Results: According to study protocol, 47 patients among the total eligible patients were excluded because of distant metastasis or tumor extension intraoperatively. The remaining 460 patients underwent distal gastrectomy with D2 lymph node dissection and were analyzed as per protocol. Estimated blood loss was lower in LAP than in OP (30 vs. 150 ml, P &lt; 0.001) and operative time was longer in LAP than in OP (291 vs. 205 min, P &lt; 0.001). Post-operative analgesics use was less in LAP than in OP (38.3 vs. 53.6 %, P = 0.001), and first day of flatus was shorter in LAP than in OP (2 vs. 3 days, P &lt; 0.001). There were no significant differences in all grade intra-operative complications (LAP 0.9% vs. OP 2.6%, P = 0.285). In addition, there were no significant differences in grade 3 and higher post-operative complications between the two groups (LAP 3.1% vs. OP 4.7%, P = 0.473). Hospital mortality was 0.4 % in each group. Conclusions: Credentialed surgeons could safely perform laparoscopic distal gastrectomy with D2 lymph node dissection for locally advanced gastric cancer. The laparoscopic approach could be accepted without increasing major surgical complications in this setting. Clinical trial information: 000003420.

Safety and efficacy of hand-assisted laparoscopic versus open distal gastrectomy for gastric cancer: A systematic review and meta-analysis

To systematically assess the safety and efficacy of hand-assisted laparoscopic distal gastrectomy (HALG) versus open distal gastrectomy (ODG) for gastric cancer. Chinese or English literature regarding comparison of HALG and ODG were collected by searching in databases (such as PubMed, Cochrane Library, CNKI, Wanfang database) between January 1996 and September 2016. The data of operative time, incision length, blood loss, number of harvested lymph nodes, time to flatus, hospital stay, postoperative complication morbidity and long-term outcomes were compared between the two procedures. Then funnel plot was used to evaluate publication bias and sensitivity analysis was used to evaluate the stability of the results. All these data analyses were performed using the Meta for or Meta package of R version 3.3.1. A total of 7 studies with 835 patients (323 cases in HALG group and 512 cases in ODG group) were included. Compared with ODG, HALG had a longer operative time (WMD=28.93 minutes, 95%CI=9.59 to 48.28, Z=2.93, P=0.000), a shorter incision length (WMD=-10.31 cm, 95%CI=-14.01 to -6.62, Z=-5.47, P=0.000), less blood loss (WMD=-140.08 ml, 95%CI=-215.07 to -65.09, Z=-3.66, P=0.000), faster gastrointestinal recovery (WMD=-1.23 days, 95%CI=-1.89 to -0.56, Z=-3.62, P=0.000), shorter postoperative hospital stay (WMD=-3.24 days, 95%CI=-5.47 to -1.02, Z=-2.85, P=0.000). In subgroup analysis, 3 studies published before 2013 vs. 4 studies published afterwards, the number of harvested lymph nodes (WMD=-0.78, 95%CI=-2.05 to 0.50, Z=-1.19, P=0.235) and postoperative complication morbidity (RR=1.02, 95%CI=0.43 to 2.44, Z=0.05, P=0.961) did not differ significantly between two groups. Compared with ODG, the RR(95%CI) of ileus of HALG was 0.43 (0.07 to 2.82), but the difference was not statistically significant (P=0.383). One study reported the 5-year overall survival rates of HALG and ODG were 81.0% vs 67.5%, and the tumor recurrence rates were 7.1% vs 22%, respectively, but the differences were not statistically significant(all P>0.05). Sensitivity analysis showed that the above results were stable. The funnel plots of the lymph nodes and postoperative complication morbidity did not present significant publication bias. HALG has the advantages of minimal invasiveness such as shorter incision length and quicker recovery. Furthermore, the short-term efficacy of HALG is similar to conventional open surgery. However, the long-term efficacy is lack of support from multicenter long-term follow-up results.

Clinical efficacy of surgical treatment for stage IV gastric cancer after conversion therapy

Clinical efficacy of surgical treatment for stage IV gastric cancer after conversion therapy