Gyu Seok Cho

Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial).

Objective:The aim of this study was to evaluate the safety of this trial with respect to morbidity and mortality. Summary Background Data:Laparoscopic-assisted distal gastrectomy (LADG) is rapidly gaining popularity. However, there is limited evidence regarding its oncologic safety. We therefore conducted a phase III multicenter, prospective, randomized study comparing LADG with open gastrectomy (ODG). Methods:Patient eligibility criteria were pathologically-proven adenocarcinoma, 20 to 80 years of age, preoperative stage I, no history of other cancer, chemotherapy, or radiotherapy. The primary end point was to determine whether there is a difference in overall survival between 2 groups. The morbidity and mortality were compared to evaluate the safety of this trial. The time was decided on the hypothesis that the morbidity of this trial was not significantly different from that of previous reports on open gastric cancer surgeries (17%–20%). This study is registered at ClinicalTrials.gov and carries the following ID number: NCT00452751. Results:A total of 342 patients were randomized (LADG, 179 patients; ODG, 161 patients) between January 1, 2006 and July 19, 2007. There were no significant differences between the 2 groups in age, gender, and comorbidities. The postoperative complication rates of the LADG and ODG groups were 10.5% (17/179) and 14.7% (24/163), respectively (P = 0.137). Reoperations were required in 3 cases each group. The postoperative mortality was 1.1% (2/179) and 0% (0/163) in the LADG and ODG groups (P = 0.497), respectively. Conclusion:There was no significance difference in the morbidity and mortality between the 2 groups. Therefore, we conclude that this trial is safe and is thus ongoing.

Long-Term Results of Laparoscopic Gastrectomy for Gastric Cancer: A Large-Scale Case-Control and Case-Matched Korean Multicenter Study

PURPOSE The oncologic outcomes of laparoscopy-assisted gastrectomy for the treatment of gastric cancer have not been evaluated. The aim of this study is to validate the efficacy and safety of laparoscopic gastrectomy for gastric cancer in terms of long-term survival, morbidity, and mortality retrospectively. PATIENTS AND METHODS The study group comprised 2,976 patients who were treated with curative intent either by laparoscopic gastrectomy (1,477 patients) or open gastrectomy (1,499 patients) between April 1998 and December 2005. The long-term 5-year actual survival analysis in case-control and case-matched population was conducted using the Kaplan-Meier method. The morbidity and mortality and learning curves were evaluated. RESULTS In the case-control study, the overall survival, disease-specific survival, and recurrence-free survival (median follow-up period, 70.8 months) were not statistically different at each cancer stage with the exception of an increased overall survival rate for patients with stage IA cancer treated via laparoscopy (laparoscopic group; 95.3%, open group: 90.3%; P < .001). After matching using a propensity scoring system, the overall survival, disease-specific survival, and recurrence-free survival rates were not statistically different at each stage. The morbidity of the case-matched group was 15.1% in the open group and 12.5% in the laparoscopic group, which also had no statistical significance (P = .184). The mortality rate was also not statistically significant (0.3% in the open group and 0.5% in the laparoscopic group; P = 1.000). The mean learning curve was 42. CONCLUSION The long-term oncologic outcomes of laparoscopic gastrectomy for patients with gastric cancer were comparable to those of open gastrectomy in a large-scale, multicenter, retrospective clinical study.

The impact of comorbidity on surgical outcomes in laparoscopy-assisted distal gastrectomy: a retrospective analysis of multicenter results.

Objective:The purpose of this study was to evaluate the impact of comorbidities on the surgical outcomes in laparoscopy-assisted distal gastrectomy (LADG). Summary Background Data:Although laparoscopic gastrectomy is less invasive than conventional open surgery, surgeons are still concerned with surgical outcomes associated with comorbidity. Methods:We retrospectively collected data on 1324 patients who underwent LADG between April 1998 and December 2005 by 10 surgeons in 10 hospitals. After excluding 87 patients who had an unusual medical history or surgical methods, 1237 patients were enrolled for analysis to evaluate the effect of comorbidities on the surgical outcomes. Results:Seven patients (0.6%) died during their hospitalization, and postoperative complications occurred in 162 (13.1%) of 1237 patients. According to univariate analysis, gender, number of comorbidities, reconstruction type, and the surgeons experience in laparoscopy-assisted gastrectomy (LAG) were related to postoperative local complications; age and comorbidity were related to systemic complications; and comorbidity was the only variable related to hospital mortality. Comorbidity was a predictive risk factor for local complications (odds ratio (OR): 1.79) and systemic complications (OR: 2.89) in multivariate analysis. The patients with pulmonary comorbidity were related to most types of immediate postoperative complications compared with other comorbidities. Conclusions:Our study suggests that comorbidities of patients could be a predictive risk factor for surgical complication after LADG. Therefore, patients with early gastric cancer having comorbidity should be considered for one of the limited surgeries. In addition, surgeons should carefully assess patients with comorbidities with full perioperative attention.

Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer Short-term Outcomes From a Multicenter Randomized Controlled Trial (KLASS-01)

OBJECTIVE To determine the safety of laparoscopy-assisted distal gastrectomy (LADG) compared with open distal gastrectomy (ODG) in patients with clinical stage I gastric cancer in Korea. BACKGROUND There is still a lack of large-scale, multicenter randomized trials regarding the safety of LADG. METHODS A large-scale, phase 3, multicenter, prospective randomized controlled trial was conducted. The primary end point was 5-year overall survival. Morbidity within 30 postoperative days and surgical mortality were compared to evaluate the safety of LADG as a secondary end point RESULTS : A total of 1416 patients were randomly assigned to the LADG group (n = 705) or the ODG group (n = 711) between February 1, 2006, and August 31, 2010, and 1384 patients were analyzed for modified intention-to-treat analysis (ITT) and 1256 were eligible for per protocol (PP) analysis (644 and 612, respectively). In the PP analysis, 6 patients (0.9%) needed open conversion in the LADG group. The overall complication rate was significantly lower in the LADG group (LADG vs ODG; 13.0% vs 19.9%, P = 0.001). In detail, the wound complication rate of the LADG group was significantly lower than that of the ODG group (3.1% vs 7.7%, P < 0.001). The major intra-abdominal complication (7.6% vs 10.3%, P = 0.095) and mortality rates (0.6% vs 0.3%, P = 0.687) were similar between the 2 groups. Modified ITT analysis showed similar results with PP analysis. CONCLUSIONS LADG for patients with clinical stage I gastric cancer is safe and has a benefit of lower occurrence of wound complication compared with conventional ODG.

Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01)

A randomized controlled trial to evaluate the long-term outcomes of laparoscopic distal gastrectomy for gastric cancer is currently ongoing in Korea. Patients with cT1N0M0-cT2aN0M0 (American Joint Committee on Cancer, 6th edition) distal gastric cancer were randomized to receive either laparoscopic or open distal gastrectomy. For surgical quality control, the surgeons participating in this trial had to have performed at least 50 cases each of laparoscopy-assisted distal gastrectomy and open distal gastrectomy and their institutions should have performed more than 80 cases each of both procedures each year. Fifteen surgeons from 12 institutions recruited 1,415 patients. The primary endpoint is overall survival. The secondary endpoints are disease-free survival, morbidity, mortality, quality of life, inflammatory and immune responses, and cost-effectiveness (ClinicalTrials.gov ID: NCT00452751).

Is gastrectomy mandatory for all residual or recurrent gastric cancer following endoscopic resection? a large‐scale Korean multi‐center study

To clarify optimal treatment guidelines for residual or local recurrence after endoscopic resection (ER).

Long-Term Efficacy of Endoscopic Submucosal Dissection Compared with Surgery for Early Gastric Cancer: A Retrospective Cohort Study

Background/Aims This study aimed to compare the outcomes of endoscopic submucosal dissection (ESD) and gastrectomy based on the two sets of indications for ESD, namely guideline criteria (GC) and expanded criteria (EC). Methods Between January 2004 and July 2007, 213 early gastric cancer (EGC) patients were enrolled in this study. Of these patients, 142 underwent ESD, and 71 underwent gastrectomy. We evaluated the clinical outcomes of these patients according to the criteria. Results The complication rates in the ESD and gastrectomy groups were 8.5% and 28.2%, respectively. The duration of hospital stay was significantly shorter in the ESD group than the gastrectomy group according to the GC and EC (p<0.001 and p<0.001, respectively). There was no recurrence in the ESD and gastrectomy groups according to the GC, and the recurrence rates in the ESD and gastrectomy groups were 4.7% and 0.0% according to the EC, respectively (p=0.279). The occurrence rates of metachronous cancer in the ESD and gastrectomy groups were 5.7% and 5.0% according to the GC (p=1.000) and 7.5% and 0.0% according to the EC (p=0.055), respectively. Conclusions Based on safety, duration of hospital stay, and long-term outcomes, ESD may be an effective and safe first-line treatment for EGC according to the EC and GC.

Intrahepatic Splenosis Mimicking Liver Metastasis in a Patient with Gastric Cancer

A 54 year old man was referred to our hospital with gastric cancer. The patient had a history of splenectomy and a left nephrectomy as a result of a traffic accident 15 years earlier. The endoscopic findings were advanced gastric cancer at the lower body of the stomach. Abdominal ultrasonography (USG) and magnetic resonance imaging demonstrated a metastatic nodule in the S2 segment of the liver. Eventually, the clinical stage was determined to be cT2cN1cM1 and a radical distal gastrectomy, lateral segmentectomy of the liver were performed. The histopathology findings confirmed the diagnosis of intrahepatic splenosis, omental splenosis. Hepatic splenosis is not rare in patients with a history of splenic trauma or splenectomy. Nevertheless, this is the first report describing a patient with gastric cancer and intrahepatic splenosis that was misinterpreted as a liver metastatic nodule. Intra-operative USG guided fine needle aspiration should be considered to avoid unnecessary liver resections in patients with a suspicious hepatic metastasis.

Transvaginal Endoscopic Appendectomy

Since Kalloo and colleagues first reported the feasibility and safety of a peroral transgastric approach in the porcine model in 2004, various groups have reported more complex natural orifice transluminal endoscopic surgery (NOTES) procedures, such as the cholecystectomy, splenectomy and liver biopsy, in the porcine model. Natural orifice access to the abdominal cavity, such as transgastric, transvesical, transcolonic, and transvaginal, has been described. Although a novel, minimally invasive approach to the abdominal cavity is a peroral endoscopic transgastric approach, there are still some challenging issues, such as the risk of infection and leakage, and the method of gastric closure. Hybrid-NOTES is an ideal first step in humans. Human hybrid transvaginal access has been used for years by many surgeons for diagnostic and therapeutic purposes. Here, we report a transvaginal flexible endoscopic appendectomy, with a 5-mm umbilical port using ultrasonic scissors in a 74-year-old woman with acute appendicitis.

Conventional Linear versus Purse-string Skin Closure after Loop Ileostomy Reversal: Comparison of Wound Infection Rates and Operative Outcomes.

Purpose Wound infection after an ileostomy reversal is a common problem. To reduce wound-related complications, purse-string skin closure was introduced as an alternative to conventional linear skin closure. This study is designed to compare wound infection rates and operative outcomes between linear and purse-string skin closure after a loop ileostomy reversal. Methods Between December 2002 and October 2010, a total of 48 consecutive patients undergoing a loop ileostomy reversal were enrolled. Outcomes were compared between linear skin closure (group L, n = 30) and purse string closure (group P, n = 18). The operative technique for linear skin closure consisted of an elliptical incision around the stoma, with mobilization, and anastomosis of the ileum. The rectus fascia was repaired with interrupted sutures. Skin closure was performed with vertical mattress interrupted sutures. Purse-string skin closure consisted of a circumstomal incision around the ileostomy using the same procedures as used for the ileum. Fascial closure was identical to linear closure, but the circumstomal skin incision was approximated using a purse-string subcuticular suture (2-0 Polysorb). Results Between group L and P, there were no differences of age, gender, body mass index, and American Society of Anesthesiologists (ASA) scores. Original indication for ileostomy was 23 cases of malignancy (76.7%) in group L, and 13 cases of malignancy (77.2%) in group P. The median time duration from ileostomy to reversal was 4.0 months (range, 0.6 to 55.7 months) in group L and 4.1 months (range, 2.2 to 43.9 months) in group P. The median operative time was 103 minutes (range, 45 to 260 minutes) in group L and 100 minutes (range, 30 to 185 minutes) in group P. The median hospital stay was 11 days (range, 5 to 4 days) in group L and 7 days (range, 4 to 14 days) in group P (P < 0.001). Wound infection was found in 5 cases (16.7%) in group L and in one case (5.6%) in group L (P = 0.26). Conclusion Based on this study, purse-string skin closure after a loop ileostomy reversal showed comparable outcomes, in terms of wound infection rates, to those of linear skin closure. Thus, purse-string skin closure could be a good alternative to the conventional linear closure.