Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results : RefluxStop™ device; a new method in acid reflux surgery obtaining CE mark.

BACKGROUND: RefluxStop™ is an implantable, non-active, single use device used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original, anatomically correct position. This new device restores normal anatomy, leaving the food passageway unaffected. METHODS: In a prospective, single arm, multicentric clinical investigation analyzing safety and effectiveness of the RefluxStop™ device to treat GERD, 50 subjects with chronic GERD were operated using a standardized surgical technique between December 2016 and September 2017. They were followed up for 1 year (CE-mark investigation 6-months). Primary safety outcome was prevalence of serious adverse events related to the device, and primary effectiveness outcome reduction of GERD symptoms based on GERD-HRQL score. Secondary outcomes were prevalence of adverse events other than serious adverse events, reduction of total acid exposure time in 24-h pH monitoring, and reduction in average daily PPI usage and subject satisfaction. RESULTS: There were no serious adverse events related to the device. Average GERD-HRQL total score at 1 year improved 86% from baseline (p < 0.001). 24-h pH monitoring compared to baseline showed a mean reduction percentage of overall time with pH < 4 from 16.35 to 0.80% at the 6-month visit (p < 0.001), with 98% of subjects showing normal 24-h pH. At 1 year: No new cases of dysphagia were recorded, present in 2 subjects, which existed already at baseline. Regular daily PPI usage occurred in all 50 subjects at baseline. At 1-year follow-up, only 1 subject took regular daily PPIs due to a too low placement of the device thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in 7 subjects. CONCLUSION: The new principle of RefluxStop™ is safe and effective to treat GERD according to investigation results. At 1-year follow-up, both the GERD-HRQL score and 24-h pH monitoring results indicate success for the new treatment principle. In addition, with the dynamic treatment for acid reflux, which avoids compressing the food passageway, prevalence of dysphagia and gas bloating are significantly reduced. TRIAL REGISTRATION: ClinicalTrials.gov , NCT02759094 . Registered 3 May, 2016.

[Role of a computer program in gastric cancer surgery - beyond the evidence]. / A számítógépes program szerepe a gyomortumor-sebészetben ­ Túl az evidencián.

INTRODUCTION: Forty percent of patients with gastric cancer have an unnecessarily extended lymph node dissection with a higher rate of morbidity and mortality. While the Maruyama computer program (MCP) can estimate the lymph node involvement before the surgery, the Maruyama Index (MI) could be a good predictor of overall and disease free survival. METHODS: To measure the probability calculations by MCP, we had to define different "cut-off" levels, with using the calculation of the receiver-operating characteristics analysis. The long term oncological results, as the overall survival (OS) and disease free survival (DFS) were calculated in correlation with the extension of lymphadenectomy (D1 versus D2) and Maruyama Index (MI < 5 versus MI ≥ 5). RESULTS: 74 patients were investigated by the Maruyama computer program preoperatively for the short-term results, and the data of 101 patients were eligible for evaluation of the long-term oncological outcomes. The MCP had a 90.2% of sensitivity, 63.3% of specificity and 78.4% of accuracy. The positive predictive value was 75.5% and the negative predictive value was 84%. In D1 group the DFS was 93.6 months and 68.7 months in D2 group (p = 0.41; HR = 1.34), and the OS was 74.6 and 72.2 months respectively (p = 0.66; HR = 0.87). In patients with MI < 5 the DFS was 92 months and 62.5 months in patients with MI ≥ 5 (p = 0.31; HR = 1.4), while the OS was 86 months and 60.4 months (p = 0.17; HR = 1.52). CONCLUSIONS: Our results proved, that the computerized prediction of LN metastases is efficient and the long term results suggest, that the MI < 5 has a better impact on survival, than the D-level guided surgery.

[First outcomes, since being full member of Eurotransplant. A single center experience of cadaveric kidney transplantation]. / Eredményeink a teljes jogú Eurotransplant-tagság óta. A Debreceni Vesetranszplantációs Központ tapasztalatai.

INTRODUCTION: The first renal transplantation was completed in 1991 at the University of Debrecen. In 2013 Hungary joined Eurotransplant. AIM: The authors retrospectively compared the trends. METHOD: Comparison between Period A (from January 1, 2008 to August 31, 2013) and Period B (from September 1, 2013 to October 22, 2015). RESULTS: The proportion of living transplants rose from 3.5% to 9.1 %. During period B over 25% of utilized donors were over 60 years of age. Recipients with body mass index above 30 kg/m(2) increased from 12% to 31%. Prevalence of diabetes among recipients rose twofold. Uretero-neocystostomy was used during period A (99%) while in period B end to side uretero-ureteral anastomosis has also gained popularity (68%). In 2013 the authors introduced routine use of induction treatment. Acute rejection rate decreased from 34% to 8%. The rate of surgical complications did not change. Acute bacterial infections decreased from 41% to 33%. Cumulative renal allograft 1, 3 and 5 year survival rates were 86.6%, 85% and 82.7% in group A vs. projected rates 88%, 84% and 84% in group B, respectively. CONCLUSIONS: Despite the growing proportion of expanded criteria donors, the authors were able to maintain a low incidence of delayed graft function and a favorable graft survival. Since 2013 the authors introduced treatments for acute humoral rejection according to international standards.

[Allograft nephrectomy - a single-center experience]. / Graftectomiák a debreceni vesetranszplantációs programban.

INTRODUCTION: Indication and timing of allograft nephrectomy is still uncertain in some cases. AIM: The aim of the authors was to summarize their experience with graftectomies. METHOD: Data from patients who underwent kidney transplantation between January 1, 2004 and December 31, 2015 were retrospectively analyzed. Frequency, indications, timing, complications as well as early and late allograft nephrectomies were reviewed. RESULTS: From 480 renal transplants, 55 graftectomies were performed (11%). Frequent indications included chronic allograft nephropathy (47%), arterial blood supply complications (13%), ureter complications (9%). 22 cases (40%) of allograft nephrectomies were urgent while 33 cases (60%) were elective. 24% of graftectomies were performed within 30 days after transplantation and 76% thereafter. CONCLUSIONS: The main indications for early graftectomies were arterial complications (31%) and chronic allograft nephropathy (62%) in cases of late graftectomies. The majority of the graftectomies were elective. Leading indication was chronic allograft nephropathy. Early and late graftectomies have different characteristics.

Prospective, comparative study for the evaluation of lymph node involvement in gastric cancer: Maruyama computer program versus sentinel lymph node biopsy.

BACKGROUND: Stage-adapted surgery guarantees the best outcome for patients with gastric cancer. Successful identification of lymph node involvement may help to reduce the number of extended lymphadenectomies. Preoperative diagnostic tools have low sensitivity and specificity for determining lymph node involvement. Evaluation of sentinel lymph nodes (SLNs) intraoperatively has good results, while the accuracy of the Maruyama computer program (MCP) is controversial. METHODS: We investigated 40 patients by the Maruyama computer model and labeled lymph nodes with blue dye for SLN mapping. To compare the probability calculations by MCP and the results of SLN mapping, we had to define a cutoff level; we did this using receiver-operating characteristics analysis. Sentinel lymph nodes were examined in frozen sections intraoperatively and by standard hematoxylin and eosin staining postoperatively. RESULTS: A total of 795 lymph nodes were removed and examined. The Maruyama computer model had a sensitivity of 91.3 %, specificity of 64 %, and accuracy of 80 % by the best cutoff point. The false-negative rate was 8.7 %. The sensitivity of SLN mapping was 95.7 %, the false-negative rate was 4.3 %, and the specificity was 100 %. The accuracy of SLN mapping was 97.4 %. Only the sensitivity of MCP and SLN biopsy was proven equivalent. CONCLUSIONS: Our results suggest that intraoperative SLN examination is superior to preoperative estimation with the MCP. Correct definition of lymph node involvement helps in planning the best stage-adapted surgery in gastric cancer.

[Prospective comparative study of sentinel lymph node mapping in gastric cancer -- submucosal versus subserosal marking method]. / Gyomortumorok orszemnyirokcsomó-jelölésének prospektív, összehasonlító vizsgálata -- submucosus kontra subserosus jelölés.

BACKGROUND: Forty percent of patients with gastric cancer undergo unnecessary extended lymph node dissection which may result in higher rate of morbidity and mortality. Successful sentinel lymph node (SLN) mapping may help to reduce the number of extended lymphadenectomy. Various marking methods are in use to detect the sentinel lymph node in gastric cancer. METHODS: Forty consecutive patients underwent open gastric resection with blue dye mapping and modified D2 lymph node dissection. Sixteen patients (group A) were marked submucosally with endoscopy and 24 patients (group B) were labelled by the surgeon subserosally. The staining method and the lymphadenectomy were supervised by the same surgeon. RESULTS: A total of 795 lymph nodes were removed and examined. The mean number of blue nodes was 4.1 per patient in group A and 4.8 in group B. The false negative rate was 0% in group A and 7.7% in group B. The sensitivity and specificity of SLN mapping was 100% in the submucosal group. The specificity of subserosal marking method was 100%, while the seínsitivity was 92.3%. Submucosal and subserosal marking methods were proven to be equivalent in detection rate, sensitivity and specificity based on 90% confidence interval of the ratio of indicators. CONCLUSIONS: Our results suggest that sentinel lymph node mapping with blue dye alone represents a safety procedure and seems to be adaptable with high sensitivity and specificity, especially in cases of T1 and T2 tumors.

Value of sentinel lymph node mapping using a blue dye-only method in gastric cancer: a single-center experience from North-East Hungary.

BACKGROUND: Forty percent of patients with gastric cancer have unnecessarily extended lymph node dissections with higher rates of morbidity and mortality than those in non-extended procedures. Successful sentinel lymph node (SLN) mapping may help to reduce the number of extended lymphadenectomies. METHODS: SLN mapping was investigated by a blue dye-only method in patients with gastric cancer. The first cohort of patients (n = 16) were marked submucosally by an endoscopist and in the second cohort of patients (n = 23) a subserosal injection was performed by the surgeon. RESULTS: Thirty-nine patients, all Caucasians, underwent gastric resection or total gastrectomy with SLN biopsy using patent blue-dye mapping and modified D2 lymphadenectomy. The mapping procedure and the lymphadenectomy were supervised by the same surgeon. A total of 770 lymph nodes were removed and examined. The mean number of blue nodes was 4.3 per patient. In 22/23 cases at least one SLN showed tumor involvement. The sensitivity of SLN mapping was 95.7%, the false-negative rate was 4.3%, and the specificity was 100%. The negative predictive value was 93.8% and the positive predictive value was 100%. In cases of T1 and T2 tumors the sensitivity was 100%. We found the two marking methods (submucosal vs. subserosal) to be equivalent and there was no side-effect of the blue-dye mapping. CONCLUSIONS: Our results suggest that SLN mapping with blue dye alone represents a safe procedure that seems to be adaptable for non-obese patients undergoing open surgery for gastric cancer in the Eastern European region. The procedure has high sensitivity and specificity, especially in cases of T1 and T2 tumors.

Short-term adaptation of rat intestine to ileostomy: implication for pediatric practice.

BACKGROUND: Surgical neonates with complex intestinal conditions, such as enterocolitis, midgut volvulus with bowel loss and multiple atresias, often require temporary stomas. Little is known on the postsurgical response of the altered gut segments, although adaptation is an important consideration in neonatal postoperative care, particularly after stoma closure. MATERIALS AND METHODS: Rats underwent bowel resection at a point 15 cm proximal to the ileocecal valve, and a split ileostomy was performed. On the 6th postoperative day the mucosal thickness was calculated with Soft Imaging System Analysis Pro, the rate of proliferation was measured following Ki67 immunohistochemistry and the apoptotic index was determined on sections stained with ApopTag Plus. The intestinal motor activity was recorded on isolated gut segments. Neuronal nitric oxide synthase (nNOS) expression and distribution was examined with NADPH-diaphorase histochemistry and Western blot analysis. RESULTS: An increased wet weight of the mucosa and a pronounced mucosal thickening were observed in the proximal functional bowel segment. Enterocyte proliferation rate was increased significantly, while the apoptotic index remained unchanged in the epithelial layer. The dilation of the gut lumen resulted in a morphological change in the nitrergic myenteric network with an overexpression of nNOS. As a consequence of the surgical procedure, the functional proximal gut segment showed strong and frequent contraction waves, with an enhanced responsiveness to cholinergic stimuli. CONCLUSIONS: The dilated functional bowel segment was characterized by hyperplasic changes in the mucosa and stronger mechanical activity with overproduction of nNOS. Although early restoration of intestinal continuity is recommended, our observations on adaptive changes may partly explain intestinal motility disorders after early stoma closure, suggesting the need for a careful approach to a redo-laparotomy.

[Increasing dominance of laparoscopic techniques in the surgery of the spleen in hematologic syndromes]. / A laparoszkópia elterjedése a lépsebészetben haematológiai kórképek esetén.

Parallel with the evolution of minimally invasive techniques more and more organs became the subject of different laparoscopic operations. The spleen was not an exception to this trend, the first laparoscopic splenectomy was performed in 1991. In the present publication the authors give an overview of their own initial experience with the technique. Between the time period of January 1996 and April 2005, 204 splenectomies were carried out at the 1st Dept. of Surgery, University of Debrecen. The indication was haematological in 113 cases, the choice of operation was laparoscopic splenectomy in 18 cases. The male-female ratio was 7 to 11, the mean age was 45.6 years (21-71). The average operation time lasted 106 minutes (60-200 min.), the mean hospital stay was 11.9 days (5-50 days). Laparoscopy had to be converted to open procedure in three cases, because of bleeding and adhesions. In one case, laparoscopic reoperation was necessary with the indication of subphrenic haematoma on the fifth postoperative day. One death occurred in this series from bilateral pneumonia. The authors conclude that laparoscopic splenectomy can be carried out safely, blood loss is limited, and the widely recognized advantages of laparoscopic techniques can be secured for the patients.