Hong Man Yoon

Long-term survival after endoscopic resection versus surgery in early gastric cancers.

BACKGROUND AND STUDY AIM Endoscopic resection for early gastric cancers that meet the expanded indication is considered to be an investigational treatment. The study aim was to evaluate long-term outcomes of endoscopic resection compared with surgery for early gastric cancers meeting the expanded indication. METHODS We retrospectively reviewed data from patients who underwent endoscopic resection or surgery for gastric cancers meeting the expanded indication between 2001 and 2009. Overall survival rate was the primary outcome; gastric cancer recurrence rates and complication rates were secondary outcomes. RESULTS Among 457 patients included, 165 underwent endoscopic resection and 292 surgery, with median follow-up duration of 58.6 months. The 5-year overall survival rates were 97.5 % and 97.0 % for endoscopic resection and surgery, respectively; Kaplan-Meier analysis showed no significant difference (P = 0.425). The 5-year gastric cancer recurrence rate was higher for endoscopic resection than for surgery (4.8 % vs. 0.3 %; P < 0.001) mainly because of metachronous cancers which developed only in the endoscopic resection group (9/165, 5.5 %). Most of the metachronous cancers (88.9 %) were curatively treated with endoscopic resection. Early complication rates were similar between the groups (P = 0.557), but the endoscopic resection group had more grade III or higher complications according to the Clavien-Dindo classification compared with the surgery group (4.8 % vs. 1.4 %, P = 0.026). Late complications occurred only following surgery (4.8 %, P = 0.004), and most (92.9 %) were grade III or higher. CONCLUSIONS Endoscopic resection may be an optimal alternative to surgery for gastric cancers that meet the expanded indication criteria, because of a comparable long-term overall survival rate.

Is the New Seventh AJCC/UICC Staging System Appropriate for Patients with Gastric Cancer?

BACKGROUND The purpose of this study was to compare the clinical usefulness of the seventh Union Internationale Contre le Cancer/American Joint Committee on Cancer (AJCC/UICC) staging system vs the sixth AJCC/UICC staging system in patients with gastric cancer. STUDY DESIGN Included were 1,799 patients who underwent surgery for gastric cancer between January 2001 and June 2005 at the National Cancer Center (South Korea). For the sixth and seventh AJCC/UICC staging systems, survival outcomes stratified by stage, by T classification, and by N classification were summarized using Kaplan-Meier curves and compared statistically using a log rank test; survival differences were quantified using hazard ratios estimated from a Cox regression model. The 2 systems were compared in terms of prognostic performances using the linear trend chi-square test, likelihood ratio chi-square test, and Akaike information criterion (AIC) in the Cox regression analysis. RESULTS Significant survival differences between each stage were not found using the seventh staging system, especially for stages IB, IIA, and IIB (p = 0.14 and p = 0.11). The sixth staging system had higher linear trend chi-square score and likelihood ratio chi-square score, which means better discriminatory ability, monotonicity, and homogeneity, and had smaller AIC, which indicates better optimistic prognostic stratification, especially in the N classification. The modified staging system combining the T classification of the seventh AJCC/UICC system and the N classification of the sixth system showed better prognostic performance compared with each separate version (sixth or seventh) of the staging system. CONCLUSIONS The seventh AJCC/UICC staging system is not more clinically useful than the sixth system in surgically treated patients with gastric cancer because of an inappropriate N classification. A new TNM system is required with a different N classification.

Emerging Role of Robot-assisted Gastrectomy: Analysis of Consecutive 200 Cases

Purpose Robotic surgery for gastric cancer is a promising alternative to laparoscopic surgery, but the data are limited. We aimed to evaluate whether gaining experience in robotic gastrectomy could improve surgical outcomes in the treatment of gastric cancer. Materials and Methods Two hundred and seven consecutive cases of patients with clinical stage I gastric cancer who underwent robotic surgery at the National Cancer Center of Korea between February 2009 and February 2012 were retrospectively reviewed. Surgical outcomes were analyzed and compared between the initial 100 and later 100 cases. Results Seven patients required conversion to open surgery and were excluded from further analysis. The mean operating time for all patients was 248.8 minutes, and mean length of hospitalization was 8.0 days. Twenty patients developed postoperative complications. Thirteen were managed conservatively, while 6 had major complications requiring invasive procedures. One mortality occurred owing to myocardial infarction. Operating time was significantly shorter in the latter 100 cases than in the initial 100 cases (269.9 versus 233.5 minutes, P<0.001). The number of retrieved lymph nodes was significantly greater in the latter cases (35.9 versus 39.9, P=0.032). The hospital stay of patients with complications was significantly longer in the initial cases than in the latter cases (16 versus 7 days, P=0.005). Conclusions Increased experience with the robotic procedure for gastric cancer was associated with improved outcomes, especially in operating time, lymph node retrieval, and shortened hospital stay of complicated patients. Further development of surgical techniques and technology might enhance the role of robotic surgery for gastric cancer.

Laparoscopy Assisted versus Open Distal Gastrectomy with D2 Lymph Node Dissection for Advanced Gastric Cancer: Design and Rationale of a Phase II Randomized Controlled Multicenter Trial (COACT 1001)

Purpose Laparoscopy-assisted distal gastrectomy for early gastric cancer has gained acceptance and popularity worldwide. However, laparoscopy-assisted distal gastrectomy for advanced gastric cancer is still controversial. Therefore, we propose this prospective randomized controlled multi-center trial in order to evaluate the safety and feasibility of laparoscopy assisted D2-gastrectomy for advanced stage gastric cancer. Materials and Methods Patients undergoing distal gastrectomy for advanced gastric cancer staged cT2/3/4 cN0/1/2/3a cM0 by endoscopy and computed tomography are eligible for enrollment after giving their informed consent. Patients will be randomized either to laparoscopy-assisted distal gastrectomy or open distal gastrectomy. Sample size calculation revealed that 102 patients are to be included per treatment arm. The primary endpoint is the non-compliance rate of D2 dissection; relevant secondary endpoints are three-year disease free survival, surgical and postoperative complications, hospital stay and unanimity rate of D2 dissection evaluated by reviewing the intraoperative video documentation. Discussion Oncologic safety is the major concern regarding laparoscopy-assisted distal gastrectomy for advanced gastric cancer. Therefore, the non-compliance rate of clearing the N2 area was chosen as the most important parameter for the technical feasibility of the laparoscopic procedure. Furthermore, surgical quality will be carefully reviewed, that is, three independent experts will review the video records and score with a check list. For a long-term result, disease free survival is considered a secondary endpoint for this trial. This study will offer promising evidence of the feasibility and safety of Laparoscopy-assisted distal gastrectomy for advanced gastric cancer.Trial Registration: NCT01088204 (international), NCCCTS-09-448 (Korea).

Improved survival after adding dissection of the superior mesenteric vein lymph node (14v) to standard D2 gastrectomy for advanced distal gastric cancer

BACKGROUND Extended lymph node dissection in gastric cancer (D3) was proven to have no survival benefit compared with a D2 dissection, but whether adding the superior mesenteric nodes (No. 14v) to the dissection provides survival benefit for gastric cancer patients remains controversial. METHODS From April 2001 to June 2007, 1,661 patients underwent curative resection for middle or lower third gastric cancer. Patients were grouped according to No. 14v lymphadenectomy (14vD+/14vD-). Clinicopathologic characteristics and treatment-related factors were compared between the groups. Overall survival according to the clinical stage (Union for International Cancer Control tumor-node-metastasis staging 6th edition) was analyzed using the Cox proportional hazard model. RESULTS The incidence of No. 14v lymph node metastasis was 5.0%. There was no difference in morbidity or mortality between the 14vD+ and the 14vD- groups. The proportion of locoregional recurrence was greater in 14vD- group (P = .018). In clinical stages I and II, 14v lymph node dissection did not affect overall survival; in contrast, 14v lymph node dissection was an independent prognostic factor in patients with clinical stage III/IV gastric cancer (hazard ratio, 0.58; 95% confidence interval, 0.38-0.88; P = .01). CONCLUSION Extended D2 gastrectomy including No. 14v lymph node dissection seems to be associated with improved overall survival of patients with clinical stage III/IV gastric cancer in the middle or lower third of the stomach.

History of Minimally Invasive Surgery for Gastric Cancer in Korea

Laparoscopic gastrectomy was begun in 1995 in Korea. But, there was 4 years gap to reactivate in 1999. High incidence of gastric cancer and increasing proportion of early cancer through national screening program along with huge effort and enthusiasm of laparoscopic gastric surgeon, and active academic exchange with Japanese doctors contributed development of laparoscopic gastrectomy in Korea. Study group activity of Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) group and Collaborative Action for Gastric Cancer (COACT) group were paramount to evoke large scale multicenter clinical study and various well performed clinical studies. This review encompasses mainly international publications about this area so far in Korea.

Prospective Multicenter Feasibility Study of Laparoscopic Sentinel Basin Dissection for Organ Preserving Surgery in Gastric Cancer: Quality Control Study for Surgical Standardization Prior to Phase III Trial.

AbstractThe clinical application of sentinel node biopsies in early gastric cancer is still controversial even though it appears promising. This study was conducted as a prerequisite quality control for surgical standardization of laparoscopic sentinel basin dissection (SBD) prior to the initiation of a phase III trial.Laparoscopic SBD was performed in patients with preoperative stage T1-2N0 and tumor size <4 cm in diameter. Intraoperative endoscopic submucosal injection of a standardized dual tracer was administered. All retrieved sentinel basin nodes (SBN) were investigated with intraoperative frozen hematoxylin and eosin (H&E) staining. A strict checklist consisting of 7 essential steps was followed during laparoscopic SBD as the quality control study for a phase III trial. Completion of all essential steps in the checklist for 10 cases was used to define a qualified institution.Seven institutions participated and 112 patients were enrolled in this study. However, 4 patients were excluded owing to screening failure. The mean number of cases required for institutional qualification was 15 cases (range, 13–20 cases). Sentinel basins (SB) were detected and dissected in 100 of the 108 patients (92.6%); the median number of SB and SBN was 2 and 7, respectively. Lymph node metastases were detected in 10 patients by postoperative permanent H&E staining and they were detected by SBD in all 10 patients. Frozen results of SBN were compatible with permanent staining reports.Laparoscopic SBD is feasible and demonstrated improved sensitivity in detecting metastatic lymph nodes compared to the previous study. A future phase III randomized trial comparing laparoscopic SBD with organ-preserving gastrectomy and laparoscopic standard gastrectomy seems promising for qualified institutions.

Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response Among Patients With Acute Isovolemic Anemia Following Gastrectomy: The FAIRY Randomized Clinical Trial

Importance Acute isovolemic anemia occurs when blood loss is replaced with fluid. It is often observed after surgery and negatively influences short-term and long-term outcomes. Objective To evaluate the efficacy and safety of ferric carboxymaltose to treat acute isovolemic anemia following gastrectomy. Design, Setting, and Participants The FAIRY trial was a patient-blinded, randomized, phase 3, placebo-controlled, 12-week study conducted between February 4, 2013, and December 15, 2015, in 7 centers across the Republic of Korea. Patients with a serum hemoglobin level of 7 g/dL to less than 10 g/dL at 5 to 7 days following radical gastrectomy were included. Interventions Patients were randomized to receive a 1-time or 2-time injection of 500 mg or 1000 mg of ferric carboxymaltose according to body weight (ferric carboxymaltose group, 228 patients) or normal saline (placebo group, 226 patients). Main Outcomes and Measures The primary end point was the number of hemoglobin responders, defined as a hemoglobin increase of 2 g/dL or more from baseline, a hemoglobin level of 11 g/dL or more, or both at week 12. Secondary end points included changes in hemoglobin, ferritin, and transferrin saturation levels over time, percentage of patients requiring alternative anemia management (oral iron, transfusion, or both), and quality of life at weeks 3 and 12. Results Among 454 patients who were randomized (mean age, 61.1 years; women, 54.8%; mean baseline hemoglobin level, 9.1 g/dL), 96.3% completed the trial. At week 12, the number of hemoglobin responders was significantly greater for ferric carboxymaltose vs placebo (92.2% [200 patients] for the ferric carboxymaltose group vs 54.0% [115 patients] for the placebo group; absolute difference, 38.2% [95% CI, 33.6%-42.8%]; P = .001). Compared with the placebo group, patients in the ferric carboxymaltose group experienced significantly greater improvements in serum ferritin level (week 12: 233.3 ng/mL for the ferric carboxymaltose group vs 53.4 ng/mL for the placebo group; absolute difference, 179.9 ng/mL [95% CI, 150.2-209.5]; P = .001) and transferrin saturation level (week 12: 35.0% for the ferric carboxymaltose group vs 19.3% for the placebo group; absolute difference, 15.7% [95% CI, 13.1%-18.3%]; P = .001); but there were no significant differences in quality of life. Patients in the ferric carboxymaltose group required less alternative anemia management than patients in the placebo group (1.4% for the ferric carboxymaltose group vs 6.9% for the placebo group; absolute difference, 5.5% [95% CI, 3.3%-7.6%]; P = .006). The total rate of adverse events was higher in the ferric carboxymaltose group (15 patients [6.8%], including injection site reactions [5 patients] and urticaria [5 patients]) than the placebo group (1 patient [0.4%]), but no severe adverse events were reported in either group. Conclusion and Relevance Among adults with isovolemic anemia following radical gastrectomy, the use of ferric carboxymaltose compared with placebo was more likely to result in improved hemoglobin response at 12 weeks. Trial Registration clinicaltrials.gov Identifier: NCT01725789

Is the critical pathway effective for the treatment of gastric cancer

Purpose The present study was conducted to investigate the low compliance rate of the critical pathway (CP) and whether CP is effective for treatment of gastric cancer in radical gastrectomy. Methods The medical records of 631 patients who had undergone radical gastrectomy with D2 lymph node dissection were reviewed. This study compared data from patients in early gastric cancer (EGC) and advanced gastric cancer (AGC) groups, which were further subdivided into general care (non-CP) and CP groups. Results The mean length of preoperative hospital stays were significantly different between the EGC and AGC patients (P < 0.05). However, there was no difference in the mean length of postoperative hospital stays between non-CP and CP groups among either EGC patients or AGC patients (P > 0.05). The postoperative and total cost of hospitalization was not statistically different between either of the groups (P > 0.05); however, the mean preoperative costs were significantly different (P < 0.05). Conclusion We conclude that use of the CP following gastrectomy is unnecessary. To decrease the length of hospital stay and associated costs, preoperative examination and consultation should be performed before admission.

Nonexposure endolaparoscopic full-thickness resection with simple suturing technique.

BACKGROUND AND AIM Current endoscopic full-thickness resection (EFTR) methods are limited by their transmural communication and exposure of tumor to the peritoneum. The aim of this study was to test the feasibility of a new resection technique that does not expose the mucosa to the peritoneum, although it involves an easy and secure suture method, which could be applied in the clinical setting. METHODS The nonexposure endolaparoscopic full-thickness resection with simple suturing technique was performed in four pigs. This new technique includes the steps of laparoscopic seromuscular suturing, which results in inversion of the stomach wall; EFTR of the inverted stomach wall from inside the stomach; and finally, endoscopic mucosal suturing with endoloops and clips. RESULTS En bloc and complete resections were achieved without adverse events in all pigs. The mean (± standard deviation) operation time was 137.0 ± 28.2 minutes. All pigs survived with no clinical evidence of illness until euthanasia. Gross and microscopic examination of the resection site showed healing without evidence of leakage or infection. CONCLUSION The nonexposure endolaparoscopic full-thickness resection with simple suturing technique was feasible in an animal model.