Short-term outcomes of a multicentre randomized clinical trial comparing laparoscopic pylorus-preserving gastrectomy with laparoscopic distal gastrectomy for gastric cancer (the KLASS-04 trial).

BACKGROUND: There remain concerns about the safety and functional benefit of laparoscopic pylorus-preserving gastrectomy (LPPG) compared with laparoscopic distal gastrectomy (LDG). This study evaluated short-term outcomes of a randomized clinical trial (RCT) comparing LPPG with LDG for gastric cancer. METHODS: The Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS)-04 trial was an investigator-initiated, open-label, parallel-assigned, superiority, multicentre RCT in Korea. Patients with cT1N0M0 cancer located in the middle third of the stomach at least 5 cm from the pylorus were randomized to undergo LPPG or LDG. Participants, care givers and those assessing the outcomes were not blinded to group assignment. Outcomes were 30-day postoperative morbidity rate and death at 90 days. RESULTS: Some 256 patients from nine institutions were randomized (LPPG 129 patients, LDG 127 patients) between July 2015 and July 2017 and outcomes for 253 patients were analysed. Postoperative complications within 30 days were seen in 19.3 and 15.5 per cent in the LPPG and LDG groups respectively (P = 0·419). Postoperative pyloric stenosis was observed in nine (7.2 per cent) and two (1·5 per cent) patients in the LPPG and LDG groups (P = 0·026) respectively. In multivariable analysis higher BMI was a risk factor for postoperative complications (odds ratio 1·17, 95 per cent c.i. 1·04 to 1·32; P = 0·011). Death at 90 days was zero in both groups. CONCLUSION: Postoperative complications and mortality was comparable in patients undergoing LPPG and LDG. Registration number: NCT02595086 (http://www.clinicaltrials.gov).

Laparoscopic sentinel node navigation surgery versus laparoscopic gastrectomy with lymph node dissection for early gastric cancer: short-term outcomes of a multicentre randomized controlled trial (SENORITA).

BACKGROUND: Sentinel node navigation surgery reduces the extent of gastric and lymph node dissection, and may improve quality of life. The benefit and harm of laparoscopic sentinel node navigation surgery (LSNNS) for early gastric cancer is unknown. The SENORITA (SEntinel Node ORIented Tailored Approach) trial investigated the pathological and surgical outcomes of LSNNS compared with laparoscopic standard gastrectomy (LSG) with lymph node dissection. METHODS: The SENORITA trial was an investigator-initiated, open-label, parallel-assigned, non-inferiority, multicentre RCT conducted in Korea. The primary endpoint was 3-year disease-free survival. The secondary endpoints, morbidity and mortality within 30 days of surgery, are reported in the present study. RESULTS: A total of 580 patients were randomized to LSG (292) or LSNNS (288). Surgery was undertaken in 527 patients (LSG 269, LSNNS 258). LSNNS could be performed according to the protocol in 245 of 258 patients, and a sentinel node basin was detected in 237 (96·7 per cent) Stomach-preserving surgery was carried out in 210 of 258 patients (81·4 per cent). Postoperative complications occurred in 51 patients in the LSG group (19·0 per cent) and 40 (15·5 per cent) in the LSNNS group (P = 0·294). Complications with a Clavien-Dindo grade of III or higher occurred in 16 (5·9 per cent) and 13 (5·0 per cent) patients in the LSG and LSNNS groups respectively (P = 0·647). CONCLUSION: The rate and severity of complications following LSNNS for early gastric cancer are comparable to those after LSG with lymph node dissection. Registration number: NCT01804998 ( http://www.clinicaltrials.gov).

ANTECEDENTES: La cirugía de navegación del ganglio centinela (sentinel node navigation surgery, SNNS) reduce la extensión de la resección gástrica y ganglionar, y puede mejorar la calidad de vida. Se desconoce el beneficio y el daño de la cirugía de navegación del ganglio centinela por vía laparoscópica (laparoscopic sentinel node navigation surgery, LSNNS) para el cáncer gástrico precoz. El ensayo clínico SENORITA investigó los resultados patológicos y quirúrgicos de LSNNS en comparación con la gastrectomía laparoscópica estándar (laparoscopic gastrectomy, LSG) con disección ganglionar (lymph node dissection, LND). MÉTODOS: El ensayo SENORITA fue un ensayo multicéntrico aleatorizado y controlado, iniciado por investigadores, abierto, con asignación a grupos paralelos y de no inferioridad llevado a cabo en Corea. El resultado primario fue la supervivencia libre de enfermedad a los 3 años. En el presente estudio, se describen los resultados secundarios correspondientes a morbilidad y mortalidad a los 30 días del postoperatorio. RESULTADOS: Un total de 580 pacientes fueron aleatorizados a LG (n = 292) o LSNNS (n = 288). La cirugía se realizó en 527 pacientes (LG 269, LSNNS 258). LSNNS pudo ser realizada de acuerdo con el protocolo en 245 de 258 pacientes y en 237 de 245 pacientes (96,7%) se detectó un ganglio centinela. La cirugía con preservación del estómago se realizó en 210 de 258 pacientes (81,4%). Las complicaciones postoperatorias se presentaron en 51 pacientes del grupo LSG (19,0%) y en 40 pacientes (15,5%) del grupo LSNNS (P = 0,294). Las complicaciones grado III o mayor de Clavien-Dindo se detectaron en 16 (5,9%) y 13 pacientes (5,0%) de los grupos LSG y LSNNS, respectivamente (P = 0,647). CONCLUSIÓN: El porcentaje y la gravedad de las complicaciones tras LSNNS para cancer gástrico precoz son comparables a la LSG con LND.

Percutaneous nephrostomy placement in infants and young children.

PURPOSE: The purpose of this study was to evaluate the feasibility, safety, and clinical effectiveness of ultrasound and fluoroscopy-guided percutaneous nephrostomy (PCN) placement in infants and young children. MATERIALS AND METHODS: Between January 2000 and December 2015, 57 patients had a total of 66 fluoroscopically guided PCN placement procedures. There were 37 boys and 20 girls with a mean age 8.6±15.3 (SD) months (range: 1 day-75.5months). The most common underlying disease was upper-urinary-tract obstruction, including ureteropelvic-junction stenosis (27/66, 40.9%) and ureterovesical-junction stenosis (16/66, 24.2%). Technical success, complications, clinical effectiveness, and radiation exposure were retrospectively analyzed. Technical success was defined as completion of PCN catheter in the renal calyx or proximal ureter. Complications were graded in severity using the Common Terminology Criteria for Adverse Event (version 4.03). Clinical effectiveness was evaluated with presence of decompression of the hydronephrosis on follow-up ultrasonography. RESULTS: All PCN placement procedures were technically successful. A total of 37 complications were identified in 33/37 procedures (89.2%), with transient gross hematuria (n=28) being most common (mean hematuria duration 2.2±1.4 [range: 1-6] days), which were grade 1 Postprocedural fever occurred after eight procedures; four and three patients were graded 1 and 2, respectively. Complete hydronephrosis decompression was achieved in 35/53 kidneys (66%), incomplete hydronephrosis decompression in 17/55 kidneys (32.1%), and progression of hydronephrosis was noted in 1/55 kidney (1.9%). Dose-area-product (DAP) was 44.86±89 (SD) (range: 3.7-464) µGycm2 and cumulative dose was 10.3±20.4 (SD) (range: 0.3-97.9) mGy. CONCLUSION: PCN is a feasible and effective treatment option to relieve urinary obstruction, and can serve as a bridging procedure until definitive corrective surgery in pediatric patients.

Alpha-fetoprotein is a significant prognostic factor for gastric cancer: Results from a propensity score matching analysis after curative resection.

BACKGROUND: Prognosis of alpha-fetoprotein positive gastric cancer (AFPP-GC) remains elusive so far due to disparities in cohort size and baseline characteristics in previous studies. A propensity score matching (PSM) analysis as well as multivariable model was performed for unbiased evaluation of the outcome in AFPGC. METHODS: Among 3034 gastric cancer patients who underwent curative gastric cancer surgery (R0, M0) at the National Cancer Center, Korea between 2002 and 2007, we identified 97 patients being positive for AFP either by elevation of serum-AFP levels >10 µg/L or by immunohistochemical staining. Due to marked disparities in baseline characteristics and cohort size, propensity-score-matching was performed which matched 87 AFPP-GC patients to the same number of AFP-negative gastric cancer (AFPN-GC) patients. Baseline characteristics were compared using χ2-test. Survival curves were compared using the Kaplan-Meier-method and multivariable regression analysis was performed to evaluate the effect of AFP-positivity while adjusting the effects of confounding variables. RESULTS: AFPP-GC and AFPN-GC patients revealed marked disparities in patient cohorts. After PSM, groups were balanced for age, sex, tumor size, BMI, tumor location, grade of differentiation, presence of lymphatic vessel infiltration (LVI), Lauren histologic type and stage distribution. In multivariable regression analysis of the PSM-groups, only AFP-positivity and pathologic stage were predictive for overall survival (HR 2.98, CI 95% {1.7-5.1}, p < 0.0001). Five-year-survival rates were significantly worse for AFPP-GC patients (57.9% vs. 76.1%, p = 0.014). Recurrence was significantly more frequent in AFPP-GC patients (p = 0.003). CONCLUSION: AFP can be considered as an independent negative predictor of overall and recurrence-free survival in patients with gastric cancer.

Randomized clinical trial of preoperative skin antisepsis with chlorhexidine gluconate or povidone-iodine.

BACKGROUND: Skin antiseptic agents are used to prevent surgical-site infection (SSI); few trials have reported the superiority of any specific agent in clean-contaminated abdominal surgery. This RCT was designed to compare the effectiveness of chlorhexidine gluconate and povidone-iodine. METHODS: Consecutive patients who underwent clean-contaminated upper gastrointestinal or hepatobiliary-pancreatic open surgery between 2011 and 2014 were assigned randomly to either chlorhexidine gluconate or povidone-iodine. The primary endpoint was the occurrence of SSI within 30 days of surgery. Secondary endpoints included causative organisms and risk factors for SSI. RESULTS: A total of 534 patients were randomized; 31 (5·8 per cent) developed an SSI. There was no difference in the overall SSI rate in the chlorhexidine gluconate and povidone-iodine groups: 15 of 267 (5·6 per cent) and 16 of 267 (6·0 per cent) respectively (P = 0·853). The most common causative organism was Enterococcus faecalis. In subgroup analysis, biliary-pancreatic surgery had a higher SSI rate (26 of 127, 20·5 per cent) than upper gastrointestinal (2 of 204, 1·0 per cent) and hepatic (3 of 203, 1·5 per cent) resection. Both age (60 years and over) and type of incision were associated with the risk of SSI. CONCLUSION: No difference was detected between chlorhexidine gluconate and povidone-iodine antiseptics for prevention of SSI. Registration number: NCT01495117 (http://www.clinicaltrials.gov).

Angiographic evaluation of hepatic arterial injury after cisplatin and Gelfoam-based transcatheter arterial chemoembolization for hepatocellular carcinoma in a 205 patient cohort during a 6-year follow-up.

OBJECTIVE: To evaluate the overall and cumulative incidence, degree, interval change and predictors of hepatic arterial injury (HAI) after cisplatin and Gelfoam® (Upjohn, Kalamazoo, MI)-based transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (HCC). METHODS: A total of 205 patients with HCC who underwent three or more sessions of TACE without additional surgical or local treatment were included. HAI was evaluated at each segment of the hepatic artery using a three-grade scale: 1 (slight wall irregularity), 2 (overt stenosis) and 3 (occlusion). HAI interval change was categorized into three groups: progression, stable state and improvement. Cumulative incidence of HAI was analysed using Kaplan- Meier method, and predictors of HAI (patient age, sex, portal vein thrombosis and Child-Pugh classification) were analysed by univariate logistic regression. RESULTS: HAI occurred in 50 of the 205 study patients (24.4%). The cumulative incidence of HAI was 16.0% [95% confidence interval (CI), 10.21-21.77] during 5 sessions of TACE, 52.1% (95% CI, 37.83-66.29) during 10 sessions and 68.0% (95% CI, 67.62-88.46) during 15 sessions. Initial HAI was interpreted as grades 1, 2 and 3 in 11 (22.0%), 17 (34.0%) and 22 (44.0%) patients, respectively. When the interval change was assessed in 48 patients with available follow-up TACE, 40 (83.3%) were included in the progression, 2 (4.2%) in the stable state and 6 (12.5%) in the improvement groups. The univariate analysis used to determine the predictors of HAI revealed no significant predictors. CONCLUSION: In three or more sessions of TACE, the incidence of HAI was 24%. Increasing TACE causes increased incidence of HAI. The initial presentation was most commonly grade 3, and 12.5% of the patients with HAI showed improvement of the HAI grade during follow-up TACE. ADVANCES IN KNOWLEDGE: In patients who underwent three or more sessions of cisplatin and Gelfoam-based TACE, the overall incidence of HAI was 24.4%, and increasing TACE causes increased incidence of HAI.

Combination therapy consisting of ethanol and radiofrequency ablation for predominantly cystic thyroid nodules.

SUMMARY: Predominantly cystic thyroid nodules are often aspirated before radiofrequency ablation to enhance its efficacy; however internal bleeding during the aspiration is a problem. We evaluated the feasibility and safety of ethanol ablation to control internal bleeding that occurred during preparatory aspiration. Between September 2010 and August 2011, 11 of 40 predominantly cystic nodules bled internally during fluid aspiration before radiofrequency ablation. To control the bleeding, 99% ethanol was injected. The efficacy of ethanol in controlling bleeding, final nodule volume and complications were assessed. Control of the bleeding by ethanol ablation and subsequent radiofrequency ablation was feasible in all patients. Ninety-one percent (10/11) could be treated in 1 session. The mean nodule volume dropped from 17.1 to 4.3 mL (P < .018). There were no major complications. Ethanol ablation and radiofrequency ablation combination therapy is a feasible and safe technique for treating predominantly cystic thyroid nodules that exhibit internal bleeding during preparatory aspiration.

Surgical stress after robot-assisted distal gastrectomy and its economic implications.

BACKGROUND: There is a lack of reports evaluating the outcomes of robotic gastrectomy and conventional laparoscopic surgery. The aim of this study was to compare the surgical stress response and costs of robot-assisted distal gastrectomy (RADG) with those of laparoscopy-assisted distal gastrectomy (LADG). METHODS: This prospective study compared a cohort of patients who had RADG with a cohort that underwent conventional LADG for early gastric cancer between March 2010 and May 2011. The surgical outcomes including Eastern Cooperative Oncology Group performance status and complications, surgical stress response and overall costs were compared between the two groups. RESULTS: Thirty patients were enrolled in the RADG group and 120 in the LADG group. There were no conversions. Median duration of operation was longer in the RADG group (218 (interquartile range 200-254) versus 140 (118-175) min; P < 0·001). Postoperative abdominal drain production was less (P = 0·001) and postoperative performance status was worse (P < 0·001) in the RADG group. C-reactive protein (CRP) levels on postoperative days 1 and 3, and interleukin (IL) 6 level on the third postoperative day, were lower in the LADG compared with the RADG group (CRP: P = 0·002 and P = 0·014 respectively; IL-6: P < 0·001). Costs for robotic surgery were much higher than for laparoscopic surgery (difference €3189). CONCLUSION: RADG did not reduce surgical stress compared with LADG. The substantial RADG costs due to robotic system expenses may not be justified.

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.

Percutaneous radiofrequency ablation using internally cooled wet electrodes for treatment of colorectal liver metastases.

AIM: To evaluate the efficacy and safety of internally cooled wet (ICW) electrodes, which provide interstitial infusion of saline and intra-electrode cooling simultaneously, in the percutaneous radiofrequency ablation (RFA) of liver metastases from colorectal cancer. MATERIALS AND METHODS: From February 2008 to October 2010, 27 patients with 35 hepatic metastatic lesions (mean size 1.99cm; range 0.7-3.8cm) underwent RFA using ICW electrodes. Of these 35 tumours, 32 had diameters ≤3cm, and three had diameters of 3-4cm. Moreover, 18 tumours were non-subcapsular and 17 were subcapsular. RESULTS: No patients (0%) had major complications after RFA. During follow-up (median 27 months; range 4.5-36 months), 14 of the 35 treated lesions (40%) showed local tumour progression. The local tumour progression-free survival rates at 1 and 3 years were 73 and 56%, respectively. The local tumour progression-free survival period was significantly longer in patients with tumours ≤2cm than >2cm (p<0.001), but did not differ significantly between patients with non-subcapsular and subcapsular tumours (p=0.454). The overall 1 and 3 year survival rates after RFA were 100 and 77%, respectively. CONCLUSIONS: Percutaneous RFA using ICW electrodes is safe and technically feasible for the treatment of liver metastases from colorectal cancer. It provides effective local tumour control with low complication rates and reduced number of needle placements.