Long-term outcomes of laparoscopy-assisted distal gastrectomy with suprapancreatic nodal dissection for clinical stage I gastric cancer: a multicenter phase II trial (JCOG0703)

Background

Laparoscopic gastrectomy has become a common surgical treatment for gastric cancer in eastern Asian countries. However, a large-scale prospective study to investigate the benefit of laparoscopy-assisted distal gastrectomy (LADG) regarding long-term outcomes has never been reported. We have already reported the short-term outcomes of this study. Here we report long-term outcomes as the secondary endpoints of this study after a 5-year follow-up period.

Methods

This study comprised patients with clinical stage I gastric cancer who were able to undergo a distal gastrectomy. LADG with D1 plus suprapancreatic lymph node dissection was performed by credentialed gastric surgeons who had each conducted at least 30 LADG and 30 open gastrectomy procedures. The primary endpoint was the proportion of patients who developed either anastomotic leakage or pancreatic fistula. The secondary endpoints included overall survival and relapse-free survival.

Results

From November 2007 to September 2008, 176 eligible patients were enrolled, comprising 140 patients with pathological stage IA disease, 23 patients with pathological stage IB disease, 9 patients with pathological stage II disease, and 4 patients with pathological stage IIIA disease. No patients had recurrent disease, and three of the patients died within the follow-up period. The 5-year overall survival was 98.2% (95% confidence interval 94.4–99.4%) and the 5-year relapse-free survival was 98.2% (95% confidence interval 94.4–99.4%).

Conclusions

The long-term outcomes of stage I gastric cancer patients undergoing LADG seem comparable to those of patients undergoing an open procedure, although this result should be confirmed by a randomized control trial. We have already completed accrual of 921 patients for a multicenter randomized phase III trial (JCOG0912) to confirm the noninferiority of LADG compared with open gastrectomy in terms of relapse-free survival.

     

Potentially fatal complications for elderly patients after laparoscopy-assisted distal gastrectomy

Background

The safety of surgery for gastric cancer in the elderly has been shown previously. However, potentially fatal complications based on an established severity grading system were not well described, and associated risk factors have not been assessed. The present study sought to examine severity-dependent postoperative complications after laparoscopy-assisted distal gastrectomy (LADG) in elderly patients and risk factors of potentially fatal postoperative complications.

Methods

The study included 189 patients aged 70 years or older and who underwent LADG for early gastric cancer. Patient characteristics, perioperative outcomes, postoperative complications including severity assessment using the Clavien–Dindo classification, and risk factors related to postoperative complications were analyzed.

Results

The overall complication rate was 24.9 % (47/189). The most frequent complication was abdominal fluid collection (9 cases, 4.8 %). Severe complications classified as grade III or above in the Clavien–Dindo grading system were found in 20 (10.6 %) patients. Multivariate analysis identified preoperative serum albumin concentration (odds ratio, 5.200; 95 % CI, 1.706–15.850), Roux-en-Y reconstruction (odds ratio, 3.611; 95 % CI, 1.103–11.817), and simultaneous cholecystectomy (odds ratio, 5.008; 95 % CI, 1.378–18.201) as independent predictors of a higher rate of severe postoperative complications after LADG in elderly patients.

Conclusion

The incidence of severe complications after LADG in the elderly was quite acceptable considering the risks associated with radical surgery with extensive lymphadenectomy. Preoperative serum concentrations of albumin (<4.0 g/dl), Roux-en-Y reconstruction, and simultaneous cholecystectomy are independent risk factors for severe postoperative complications in these patients.     

Short-term surgical outcomes from a phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric cancer: Japan Clinical Oncology Group Study JCOG0912

Backgrounds

No confirmatory randomized controlled trials (RCTs) have evaluated the efficacy of laparoscopy-assisted distal gastrectomy (LADG) compared with open distal gastrectomy (ODG). We performed an RCT to confirm that LADG is not inferior to ODG in efficacy.

Methods

We conducted a multi-institutional RCT. Eligibility criteria included histologically proven gastric adenocarcinoma in the middle or lower third of the stomach, clinical stage I tumor. Patients were preoperatively randomized to ODG or LADG. This study is now in the follow-up stage. The primary endpoint is relapse-free survival (RFS) and the primary analysis is planned in 2018. Here, we compared the surgical outcomes of the two groups. This trial was registered at the UMIN Clinical Trials Registry as UMIN000003319.

Results

Between March 2010 and November 2013, 921 patients (LADG 462, ODG 459) were enrolled from 33 institutions. Operative time was longer in LADG than in ODG (median 278 vs. 194 min, p < 0.001), while blood loss was smaller (median 38 vs. 115 ml, p < 0.001). There was no difference in the overall proportion with in-hospital grade 3–4 surgical complications (3.3 %: LADG, 3.7 %: ODG). The proportion of patients with elevated serum AST/ALT was higher in LADG than in ODG (16.4 vs. 5.3 %, p < 0.001). There was no operation-related death in either arm.

Conclusions

This trial confirmed that LADG was as safe as ODG in terms of adverse events and short-term clinical outcomes. LADG may be an alternative procedure in clinical IA/IB gastric cancer if the noninferiority of LADG in terms of RFS is confirmed.

     

Comparison of surgical performance and short-term clinical outcomes between laparoscopic and robotic surgery in distal gastric cancer

Aims

The authors aimed to compare the surgical performance and the short-term clinical outcomes of robotic assisted laparoscopic distal gastrectomy (RADG) with laparoscopy-assisted distal gastrectomy (LADG) in distal gastric cancer patients.

Method

From April 2009 to August 2010, 62 patients underwent LADG and 30 patients underwent RADG for preoperative stage I distal gastric cancer by one surgeon at the National Cancer Center, Korea. Surgical performance was measured using lymph node (LN) dissection time and number of retrieved LNs, which were viewed as surrogates of technical ease and oncologic quality.

Results

In clinicopathologic characteristics, mean age, depth of invasion and stage were significantly different between the LADG and RADG group. Mean dissection time at each LN station was greater in the RADG group, but no significant intergroup difference was found for numbers of retrieved LNs. Furthermore, proximal resection margins were smaller, and hospital costs were higher in the RADG group. In terms of the RADG learning curve, mean LN dissection time was smaller in the late RADG group (n = 15) than in the early RADG group (n = 15) for 4sb/4d, 5, 7-12a stations, but numbers of retrieved LNs per station were similar.

Conclusion

With the exception of operating time and cost, the numbers of retrieved LNs and the short-term clinical outcomes of RADG were found to be comparable to those of LADG, despite the surgeon’s familiarity with LADG and lack of RADG experience. Further studies are needed to evaluate objectively ergonomic comfort and to quantify the patient benefits conferred by robotic surgery.     

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.     

Does a laparoscopic approach attenuate the body weight loss and lean body mass loss observed in open distal gastrectomy for gastric cancer? a single-institution exploratory analysis of the JCOG 0912 phase III trial

Background

Laparoscopy-assisted distal gastrectomy (LADG) for gastric cancer may prevent the loss of body weight and lean body mass resulting from reduced surgical stress in comparison to open distal gastrectomy (ODG). A multicenter phase III trial conducted by the Japan Clinical Oncology Group (JCOG0912 trial) was performed to confirm the non-inferiority of LADG to ODG for stage I gastric cancer in terms of relapse-free survival.

Methods

This study was performed as a single-institution exploratory analysis using the data of the patients from our hospital who were enrolled in the JCOG0912 phase III trial. Body weight and lean body mass were evaluated using a bioelectrical impedance analyzer within 1 week before and at 1 week, 1 month, and 3 months after surgery.

Results

One-hundred six patients were randomized to undergo ODG (54 patients) or LADG (51 patients). Body weight loss at 1 week, 1 month, and 3 months was ?3.0%, ?4.9%, and ?5.4%, respectively, in the ODG group and ?2.7%, ?4.3%, and ?5.7%, respectively, in the LADG group; the differences were not statistically significant (p = 0.330, 0.166, and 0.656, respectively). Lean body mass loss at 1 week, 1 month, and 3 months was ?2.8%, ?4.1%, and ?2.3%, respectively, in the ODG group and ?2.7%, ?2.9%, and ?3.0%, respectively, in the LADG group; the differences were not statistically significant (p = 0.610, 0.413, and 0.925, respectively).

Conclusions

The laparoscopic approach did not attenuate the loss of body weight and lean body mass in comparison to patients who underwent open distal gastrectomy for gastric cancer.

     

Clinical significance of CA125 and CA72-4 in gastric cancer with peritoneal dissemination

Background  

Serum tumor markers have been shown to correlate with the clinical status of patients with advanced gastric cancer. However, the clinical significance of each tumor marker in patients with peritoneal dissemination has not been fully verified.     

Major combined electrolyte deficiency during therapy with low-dose Cisplatin, 5-Fluorouracil and Interferon alpha: report on several cases and review of the literature [ISRCTN62866759]

Background  

Low-dose Cisplatin and Interferon alpha treatment of solid tumors rarely has been associated with severe hypocalcaemia. To the authors knowledge the phenomenon has not been reported previously in patients with pancreatic carcinoma.     

Retrospective analysis of prognostic outcome of gastric cancer in young patients

Background  

It has been suggested that gastric cancer in young patients has a worse prognosis than in older patients, but this is controversial. This retrospective investigation was undertaken to understand the clinicopathological features and identify the prognostic factors of gastric cancer in young patients.     

Classical homeopathy in the treatment of cancer patients - a prospective observational study of two independent cohorts

Background  

Many cancer patients seek homeopathy as a complementary therapy. It has rarely been studied systematically, whether homeopathic care is of benefit for cancer patients.     

Hyperfibrinogenemia is associated with lymphatic as well as hematogenous metastasis and worse clinical outcome in T2 gastric cancer

Background  

Abnormal hemostasis in cancer patients has previously been described, however the correlation between the plasma fibrinogen level and cancer metastasis and prognosis has not been reported in a large-scale clinical study.     

Gemcitabine and docetaxel as a second-line treatment in advanced soft tissue sarcomas

Objective  

Promising anti-tumor activity in patients with metastatic or unresectable soft tissue sarcomas has been reported with gemcitabine and/or docetaxel.     

Laparoscopic Diagnosis of Annular Pancreas in a Patient with Mucinous Cystoadenoma of the Body of the Pancreas

Introduction  

Annular pancreas (AP) is a rare anomaly due to malrotation of the pancreatic ventral bud during embryologic development. AP has been extensively described in the pediatric population; however, in adults, the incidence has been reported to be only 1 in 22,000 patients with only a few cases presenting with simultaneous mucinous cystadenoma described in the recent literature.     

Adjuvant radiotherapy and chemotherapy in breast cancer: 30 year follow-up of survival

Background  

The long term outcome (more than 15 years) of adjuvant treatment in patients with primary operable breast cancer has rarely been examined.     

Health-related quality of life in glioma patients in China

Background  

Health-related quality of life (HRQOL) has been increasingly emphasized in cancer patients. There are no reports comparing baseline HRQOL of different subgroups of glioma patients prior to surgery.     

Questionnaire survey of the current status of radical trachelectomy in Japan

Background  

The number of young patients with cervical cancer has been increasing recently in Japan. Radical trachelectomy is a potential option for patients who wish to preserve their fertility, but its status is not clear. The present survey was conducted to clarify the status of radical trachelectomy in Japan.     

Safety and efficacy of S-1 monotherapy in elderly patients with advanced gastric cancer

Background  

Although S-1 is effective against advanced gastric cancer (AGC), its efficacy in elderly patients has not yet been investigated sufficiently. We assessed the efficacy and safety of S-1 monotherapy in elderly patients with AGC.     

An audit of nephroureterectomy for upper tract urothelial carcinoma

Background

The boundary of nephroureterctomy has been revisited and lymph node dissection has been recommended recently. We investigated the role of synchronous ipsilateral adrenalectomy in treating patients with upper tract urothelial carcinoma.

Methods

110 patients with clinically localized upper tract urothelial carcinoma treated by nephroureterectomy and bladder cuff resection were retrospectively evaluated. 70 patients underwent nephroureterectomy without concomitant ipsilateral adrenalectomy, whereas nephroureterectomy and ipsilateral adrenalectomy was performed in other 40 patients. Cancer specific, metastasis and local recurrence free survival during a follow-up of median 46 months were analyzed.

Results

No patient had adrenal metastasis among the 40 adrenalectomized patients. A total of 4 patients developed local recurrences; including 1 of the 70 adrenalectomy-sparing and 3 of the 40 adrenalectomized patients (p = 0.102, chi-square test). Five patients with adrenalectomy and four without adrenalectomy had distant metastases (p = 0.212, chi-square test). The five-year local recurrence free survival (p = 0.09, log-rank test), metastasis-free survival (p = 0.292, log-rank test), and cancer-specific survival (p = 0.117, log-rank test) did not have significant difference between both groups.

Conclusions

This is the only study in recent 2 decades to evaluate the necessity of synchronous adrenalectomy in treating localized upper tract urothelial carcinoma. Adrenal-sparing nephroureterectomy seems justified for clinically localized upper tract urothelial carcinoma.     

Glioblastoma multiforme with oligodendroglial component (GBMO): favorable outcome after post-operative radiotherapy and chemotherapy with nimustine (ACNU) and teniposide (VM26)

Background  

The presence of an oligodendroglial component within a glioblastoma multiforme (GBM) is considered a prognostically favorable factor, but the clinical outcome of patients with glioblastoma multiforme with oligodendroglial component (GBMO) after combined post-operative radiotherapy and chemotherapy has rarely been reported.     

Safety and feasibility of S-1 adjuvant chemotherapy for gastric cancer in elderly patients

Background  

The safety and feasibility of administering S-1 adjuvant chemotherapy for gastric cancer has not been fully evaluated in elderly patients.