Results of interim analysis of the multicenter randomized phase III SENORITA trial of laparoscopic sentinel node oriented, stomach-preserving surgery versus laparoscopic standard gastrectomy with lymph node dissection in early gastric cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4028-4028 ◽  
Author(s):  
Keun Won Ryu ◽  
Young Woo Kim ◽  
Jae Seok Min ◽  
Hong Man Yoon ◽  
Ji Yeong An ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Early Gastric Cancer ◽  
Sentinel Node ◽  
Lymph Node Dissection ◽  
Interim Analysis ◽  
Phase Iii ◽  
Complication Rates ◽  
Node Dissection

4028 Background: The benefits and hazards of laparoscopic sentinel node oriented stomach-preserving surgery, compared to those of laparoscopic standard gastrectomy with lymph node dissection in early gastric cancer (EGC), are unknown. The SENORITA trial investigated the clinical impact of laparoscopic sentinel node oriented stomach-preserving surgery in EGC. Methods: Other than those with absolute indication for endoscopic resection, eligible patients had EGC confined to the mucosa and submucosa, with diameter ≤ 3cm, regardless of histology on preoperative evaluation. Patients were randomized for laparoscopic standard gastrectomy or laparoscopic stomach-preserving surgery. Patients were stratified based on depth (mucosa vs. submucosa) and size (≤ 2cm vs. 2 < ≤ 3cm) of the EGC and by participating institution. The primary endpoint was 3-year disease-free survival (3yDFS). The expected 3yDFS was 97% and non-inferior margin was 5%. 580 patients and 24 events were needed to show non-inferiority with 80% power. One interim analysis was planned after 12 events (50%) occurred. Using the O’Brien-Fleming error spending function, the two-sided nominal significance level for the interim analysis would be 0.0054. Results: From March 2013 to May 2016 462 patients were randomized; analysis was performed in 421 after a dropout of 41 patients. Laparoscopic stomach-preserving surgery was possible in 75.6% by study protocol. Interim analysis was conducted based on 12 events (median follow-up: 15.89 months). The 3yDFS in the laparoscopic standard gastrectomy arm was 96%; the 3yDFS in the laparoscopic stomach-preserving surgery arm was 93%, (99.46% CI: -3.18%, 9.18%). The postoperative complication rates were 15.0% and 12.9%, respectively (p = 0.542). Conclusions: In this interim analysis, laparoscopic sentinel node oriented stomach-preserving surgery did not show non-inferiority for 3yDFS. The follow-up time was not mature enough to evaluate non-inferiority. Further follow-up will elucidate the role of laparoscopic sentinel node oriented stomach-preserving surgery. Clinical trial information: NCT01804998.

Laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy with lymph node dissection in early gastric cancer: Final three-year survival results of multicenter randomized controlled phase III trial (SENORITA trial).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4510-4510
Author(s):  
Keun Won Ryu ◽  
Young Woo Kim ◽  
Jae Seok Min ◽  
Ji Yeong An ◽  
Hong Man Yoon ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Early Gastric Cancer ◽  
Sentinel Node ◽  
Lymph Node Dissection ◽  
Node Dissection ◽  
Navigation Surgery ◽  
Sentinel Node Navigation Surgery ◽  
Free Survival ◽  
Randomized Controlled

4510 Background: The benefits and hazards of laparoscopic sentinel node navigation surgery (LSNNS), compared with laparoscopic standard gastrectomy (LSG) with lymph node dissection in early gastric cancer (EGC), are unknown. The SENORITA trial investigated the clinical impact of LSNNS in EGC in terms of short-term surgical outcomes, long-term survival and quality of life. Methods: This study is a prospective, multicenter, randomized controlled, non-inferiority trial. Patients with preoperatively diagnosed gastric adenocarcinoma with T1N0 of 3 cm or less in diameter, regardless of histology, except absolute indication for endoscopic resection were eligible. Patients were randomized to LSG or LSNNS using dual tracers. The primary endpoint is 3-year disease-free survival (3yDFS). Planned sample size per arm is 290 patients with the non-inferiority margin of 2.737 in hazard ratio (HR) assuming that LSG achieve 97% 3yDFS, 5% of type 1 error and 80% of power. Three-year recurrence-free survival (3yRFS), overall survival (3yOS) and disease specific death rate (3yDSDR) were evaluated as secondary endpoints. Results: From March 2013 to December 2016, 580 patients were randomized (LSG arm 292 vs. LSNNS arm 288). After 53 patients dropped out before surgery, operation was performed in 527 patients (269 vs. 258), representing the full analysis set. LSG was performed in 266 according to the protocol excluding 3 open conversion. After exclusion of 13 without LSNNS due to various reasons, LSNNS was performed in 245 patients according to the protocol. After median follow up of 47.5 months, 3yDFS were 95.5% and 91.8% (HR 1.901, CI 0.911 – 3.967), respectively. The 3yRFS was 98.9% and 95.2% (p=0.019), and 3yOS was 99.2% and 97.6% (p=0.166), and 3yDSDR was 99.5% and 99.1% (p=0.591), respectively. Conclusion: LSNNS in EGC did not show non-inferiority compared with LSG in terms of 3yDFS. However, 3yOS and 3yDSDR of LSNNS were comparable to LSG by the rescue surgery of recurrence. LSNNS might be an alternative surgical option instead of LSG in selected EGC patients. Clinical trial information: NCT01804998 .

Pylorus Preserving Gastrectomy (PPG) with Lymph Node Dissection for Early Gastric Cancer in the Middle Third of the Stomach

1993 ◽  
pp. 324-326
Author(s):  
Hiroshi Minato ◽  
Kiyoshi Sawai ◽  
Tsuguo Fujioka ◽  
Masahide Yamaguchi ◽  
Keisuke Kanemitsu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Early Gastric Cancer ◽  
Lymph Node Dissection ◽  
Node Dissection

Survival of SLNB-positive melanoma patients with and without complete lymph node dissection: A multicenter, randomized DECOG trial.

2015 ◽  
Vol 33 (18_suppl) ◽  
pp. LBA9002-LBA9002 ◽  
Author(s):  
Ulrike Leiter ◽  
Rudolf Stadler ◽  
Cornelia Mauch ◽  
Werner Hohenberger ◽  
Norbert Brockmeyer ◽  
...  
Keyword(s):  
Lymph Node ◽  
Lymph Node Dissection ◽  
Distant Metastases ◽  
Tumor Burden ◽  
Phase Iii ◽  
Node Dissection ◽  
Significant Treatment ◽  
Melanoma Patients ◽  
Complete Lymph Node Dissection

LBA9002 Background: Complete lymph node dissection (CLND) following positive sentinel node biopsy (SLNB) was evaluated in a randomized phase III trial. Methods: 1,258 patients with cutaneous melanoma of the trunk and extremities and with positive SLNB were evaluated. Of these, 483 (39%) agreed to randomization into the clinical trial. 241 patients underwent observation only, 242 received CLND. Both groups had a subsequent 3-years follow-up. Recurrence-free (RFS), distant metastases free (DMFS) and melanoma specific (MSS) survival were analyzed as endpoints. Results: Patient enrolment was performedfrom January 2006 to December 2014. In the intent to treat analysis, both groups did not differ significantly in distribution of age, gender, localization, ulceration, tumor thickness (median 2,4 mm in both groups), number of positive nodes, or tumor burden in the SN. The mean follow-up time was 34 months (SD ± 22.1). No significant treatment-related difference was seen in the 5-years RFS (P = 0.72), DMFS (P= 0 .76) and MSS (P = 0.86) in the overall study population. Conclusions: In this early analysis of trial results, no survival benefit was achieved by CLND in melanoma patients with positive SLNB. A subsequent analysis three years after inclusion of the last patient is planned.

Laparoscopically assisted total or distal gastrectomy with lymph node dissection for early gastric cancer

2001 ◽  
Vol 88 (1) ◽  
pp. 128-132 ◽  
Author(s):  
T. Asao ◽  
Y. Hosouchi ◽  
T. Nakabayashi ◽  
N. Haga ◽  
E. Mochiki ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Early Gastric Cancer ◽  
Lymph Node Dissection ◽  
Distal Gastrectomy ◽  
Node Dissection

scholarly journals Precision surgical approach with lymph-node dissection in early gastric cancer

2019 ◽  
Vol 25 (14) ◽  
pp. 1640-1652 ◽  
Author(s):  
Shinichi Kinami ◽  
Naohiko Nakamura ◽  
Yasuto Tomita ◽  
Takashi Miyata ◽  
Hideto Fujita ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Early Gastric Cancer ◽  
Lymph Node Dissection ◽  
Surgical Approach ◽  
Node Dissection

scholarly journals Comparision of Quality of Life Following Gastrectomy with D1 Versus D2 Lymph Node Dissection for Early Gastric Cancer.

1995 ◽  
Vol 28 (12) ◽  
pp. 2242-2247
Author(s):  
Tsuguo Fujioka ◽  
Kiyoshi Sawai ◽  
Miyakatsu Ohara ◽  
Hiroshi Minato ◽  
Yuichi Yada ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Gastric Cancer ◽  
Lymph Node ◽  
Early Gastric Cancer ◽  
Lymph Node Dissection ◽  
Node Dissection ◽  
D2 Lymph Node Dissection

Reliability and Accuracy of Sentinel Node Biopsy in Cutaneous Malignant Melanoma

2002 ◽  
Vol 88 (3) ◽  
pp. S14-S16 ◽  
Author(s):  
P Carcoforo ◽  
G Soliani ◽  
L Bergossi ◽  
E Basaglia ◽  
AR Virgili ◽  
...  
Keyword(s):  
Lymph Node ◽  
Malignant Melanoma ◽  
Sentinel Node ◽  
Lymph Node Dissection ◽  
Cutaneous Malignant Melanoma ◽  
Primary Lesion ◽  
Isosulfan Blue ◽  
Node Dissection ◽  
Positive Slns

Aims and Background The aims of this study were 1) to investigate whether sentinel lymph node (SLN) biopsy could become the method of choice for the early detection of metastatic disease in patients with malignant melanoma and 2) to identify those patients with lymph node metastases who could benefit from regional lymphadenectomy. Methods and Study Design Our study started in March 1998 and involved 110 patients with primary cutaneous malignant melanoma stage I or II (AJCC) in whom the primary lesion had been surgically removed no more than 90 days previously. On the day of lymph node dissection patients were given an intradermal injection of colloid particles of human serum albumin labeled with technetium-99m and an injection of isosulfan blue. The surgical procedure was usually performed with local anesthesia but in some cases locoregional or general anesthesia was preferred. Contralateral and ipsilateral lymphatic areas were scanned with a hand-held gamma camera (Scintiprobe MR 100) to measure the background and identify the hot point indicating the location of the sentinel node to direct the incision. Results The combined use of lymphoscintigraphy, isosulfan blue and gamma probe allowed us to identify sentinel nodes in 108 of 110 patients (98.18%) while the SLN was blue in only 90 cases (81.81%). The SLN was positive for metastases in 13 of the 108 patients (12.03%) and regional and distal lymphadenectomy was performed in all of them. The distribution of positive SLNs by primary lesion thickness was as follows: 0.76-1.5 mm: one positive SLN/44 patients (2.27%); 1.51-4 mm: six positive SLNs/51 patients (11.7%); >4 mm: six positive SLNs/15 patients (40%). Only four of 12 patients with ulcerated cutaneous melanoma had positive SLNs. The patients in our study underwent follow-up visits every four months. The median follow-up was 481 days (range, 97-1271 days). Conclusions In patients with primary cutaneous melanoma the histological status of the SLN accurately reflects the presence or absence of metastatic disease in the relevant regional lymph node basin. Complete lymph node dissection should only be performed in patients with positive SLNs. Patients with lesions >4 mm are likely to develop recurrences and to die of systemic disease, so in these patients the usefulness of SLN biopsy is questionable. In conclusion, sentinel node mapping is a rational approach for the selection of patients who might benefit from early lymph node dissection of the affected basin.

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